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  • 1
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    Long-term follow-up from STAMP, a phase II trial, evaluating sipuleucel-T and concurrent (CON) vs sequential (SEQ) abiraterone acetate + prednisone in metastatic castration-resistant prostate cancer patients (pts).
    American Society of Clinical Oncology (ASCO) ; 2017
    In:  Journal of Clinical Oncology Vol. 35, No. 6_suppl ( 2017-02-20), p. 190-190
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 35, No. 6_suppl ( 2017-02-20), p. 190-190
    Abstract: 190 Background: The optimal sequence and combination of life-extending anticancer therapies in mCRPC pts remains unknown. Sipuleucel-T (sip-T), an autologous cellular immunotherapy approved for the therapy of asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC) pts, was evaluated in combination with abiraterone acetate and prednisone (abi) in the phase II STAMP trial (NCT01487863), with pts randomly assigned to receive CON sip-T + abi or SEQ sip-T followed by abi. The combination was well-tolerated and did not alter the immune response parameters that correlate with overall survival (OS) (Small Clin Can Res 2015). Here, we present long-term follow-up of clinical outcomes, including OS. Methods: mCRPC pts were randomized 1:1 to CON or SEQ therapy with sip-T and abi. Abi began 1 day after (CON) or at wk 10 (SEQ) after the first sip-T infusion and continued for 26 wk of therapy, after which continued abi therapy was permitted. Long-term clinical outcomes included OS, disease-specific death (DSS), progressive disease (PD), time to first anticancer intervention (tACI), and safety. Results: 69 pts were enrolled (35 CON; 34 SEQ). Median OS was 34.0 mo (95% CI, 24.4-not estimable [NE]; 30.0 mo CON; 34.2 mo SEQ; p = 0.921), and median time to DSS was not reached (CON vs SEQ; p = 0.733). Median time to PD was 17.3 mo (95% CI, 9.7–NE; 17.7 mo CON vs 13.9 mo SEQ; p = 0.914; consistent with higher rates of abi discontinuation due to PD in SEQ [26.5% vs 14.3% in CON] ). tACI was similar between arms at 15.4 mo (95% CI, 11.0–19.9). No new safety signals were observed with the combination, and no discernable difference in clinical outcomes was observed with CON or SEQ treatments. Conclusions: Long-term follow-up data confirm that sip-T + CON or SEQ abi is well-tolerated, with no new safety signals. No clear differences were observed in clinical outcomes between arms, although the study was not powered to detect these differences. Future and more appropriately powered studies on the effect of sip-T + continuous abi for responding pts may provide further insights on the benefit of combination therapy. Clinical trial information: NCT01487863.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2017.35.6_suppl.190
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2017
    detail.hit.zdb_id: 2005181-5
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  • 2
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    Validation of the total illness burden index for prostate cancer (TIBI-CaP) in men with castration-resistant prostate cancer (CRPC): Data from TRUMPET.
    American Society of Clinical Oncology (ASCO) ; 2017
    In:  Journal of Clinical Oncology Vol. 35, No. 6_suppl ( 2017-02-20), p. 256-256
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 35, No. 6_suppl ( 2017-02-20), p. 256-256
    Abstract: 256 Background: The TRUMPET registry is a prospective, observational cohort study of patients (pts) with CRPC designed to evaluate treatment patterns and health-related quality of life (HRQoL) outcomes associated with CRPC and its management in a real-world setting. Comorbidities may influence how physicians approach CRPC treatment; therefore, evaluation of comorbidity presence and severity is important. The TIBI-CaP questionnaire measures comorbidity, with the aim of this analysis to validate TIBI-CaP in CRPC. Methods: Data were collected from 302 enrolled CRPC pts treated in academic and community-based sites under routine care. Baseline data collected included clinical history and self-reported demographics, comorbidities, and HRQoL. TIBI-CaP scores were analyzed based on correlation analysis and analysis of variance (ANOVA). Estimated correlations were used to verify the association of TIBI-CaP scores to scores on the SF-12v2 and FACT-P questionnaires. ANOVA models were run with SF-12v2 and FACT-P as response and quartile ranges for TIBI-CaP scores as predictor. Results: Mean age was 73.7 years. 84.7% were white; 13.9% were black. 87.8% had M1 CRPC at study entry. Mean (SD) TIBI-CaP score was 5.3 (2.72) [range 0-13], with 42.4% of CRPC pts presenting with moderate/severe comorbidity burden (higher scores). TIBI-CaP scores had statistically significant (p value 〈 0.0002) negative correlations with all SF-12v2 composite and domain scores. Correlation estimates for physical condition and mental condition scores were -0.46 and -0.23, respectively. TIBI-CaP scores also had statistically significant (p value 〈 0.02) negative correlations with FACT-P total scores and all subscales. FACT-P total scores had a -0.44 correlation estimate. F-tests showed significant differences across the four quartiles of TIBI-CaP scores and SF-12v2 and FACT-P (all p values 〈 0.05). Conclusions: At baseline, TIBI-CaP scores were negatively correlated with CRPC pts baseline functional status as measured by the SF-12v2 and FACT-P questionnaires. TIBI-CaP was strongly associated with HRQoL physical subscales. This analysis demonstrates validity of TIBI-CaP in CRPC pts.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2017.35.6_suppl.256
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2017
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  • 3
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    Use of circulating tumor DNA (ctDNA) to complement tumor tissue homologous recombination repair (HRR) gene alteration testing in TALAPRO-2, a phase 3 study of talazoparib (TALA) + enzalutamide (ENZA) versus placebo (PBO) + ENZA as first-line (1L) treatment in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC).
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 16_suppl ( 2023-06-01), p. 5056-5056
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. 5056-5056
    Abstract: 5056 Background: In TALAPRO-2 (NCT03395197), pts unselected for tumor genetic alterations in DNA damage repair pathways, directly or indirectly involved with HRR, received TALA + ENZA (n=402) or PBO + ENZA (n=403) as 1L treatment for mCRPC. HRR status was informed by tumor tissue for 804 pts (99.9%), by tumor tissue and ctDNA for 114 (14.2%), and by ctDNA only for 1 (0.1%). TALA + ENZA demonstrated statistically significant and clinically meaningful improvements in imaging-based progression-free survival over standard of care PBO + ENZA regardless of HRR gene alteration status (presented by Agarwal N at ASCO-GU 2023). Here we assessed the overall agreement of solid tissue vs ctDNA-based testing in assessing tumor HRR gene alteration status. Methods: HRR status for pts randomized in TALAPRO-2 was determined prospectively by testing for the presence of HRR gene alterations using FoundationOne CDx and/or FoundationOne Liquid CDx. Pts were considered HRR-deficient if they had ≥1 alteration in ≥1 of 12 HRR genes by either test. Plasma samples collected at screening were retrospectively tested using FoundationOne Liquid CDx to examine retrospective test performance and to support exploratory resolution of pts with unknown prospective HRR status. Results were reported as HRR-deficient, non-HRR-deficient, or unknown. Results: In prospective testing, high concordance in HRR status was observed between ctDNA and tumor tissue sample results: 95% agreement (90/95) between tests was observed in pts evaluable as either HRR-deficient or non-HRR-deficient by both tests. Retrospective ctDNA test results were reported for 739 pts (207 [28%] with a status of HRR-deficient, 480 [65%] non-HRR-deficient, and 52 [7%] unknown; 66 pts had samples not collected or reported). There was high concordance in pt-level alteration status between prospective molecular profiling (mainly based on solid tumor tissue per above) and retrospective ctDNA testing: the agreement was 84% (438/519) between tests for pts evaluable as HRR-deficient or non-HRR-deficient both prospectively and retrospectively (421/501 [84%] for prospective tumor tissue only vs retrospective ctDNA). Conclusions: Results show 95% agreement between prospective tissue and ctDNA-based HRR status using FoundationOne, consistent with tumor vs ctDNA results recently reported (Tukachinsky. Clin Cancer Res. 2021;27:3094–3105). The high agreement between prospective test results based primarily on tumor tissue and retrospectively assessed ctDNA collected at screening is supportive of exploratory retrospective testing of ctDNA to inform the HRR status of pts whose alteration status is unknown based on prospective testing. Clinical trial information: NCT03395197 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.16_suppl.5056
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
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  • 4
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    Outcomes of patients (pts) with de novo metastatic hormone-sensitive prostate cancer (mHSPC) who progressed to metastatic castration-resistant prostate cancer (mCRPC): A post-hoc analysis of the TRUMPET registry.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 16_suppl ( 2023-06-01), p. e17085-e17085
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. e17085-e17085
    Abstract: e17085 Background: Significant lack of treatment (Tx) intensification is seen in clinical practice for pts with mHSPC until progression to mCRPC. The TRUMPET registry enabled a post-hoc analysis of clinical outcomes in pts with mCRPC, initially diagnosed with de novo mHSPC vs nmHSPC. Methods: TRUMPET, a prospective, observational study of US pts with CRPC, enrolled male adults (03/2015-09/2018) who began first or second-line Tx for M0/M1 CRPC. For this post hoc, pts with M1 CRPC at enrollment initially diagnosed with de novo mHSPC (clinical TNM1 stage) were compared to M1 CRPC pts initially diagnosed with nmHSPC (clinical TNM0 stage). Clinical outcomes (radiographic progression-free survival [rPFS], prostate specific antigen [PSA] progression, time to opiate initiation [OI], mortality) were analysed with Kaplan–Meier and Cox proportional hazards models. An exploratory subanalysis investigated outcomes in de novo mHSPC pts who received Tx intensification (docetaxel or abiraterone) with androgen-deprivation therapy (ADT) as primary Tx prior to mCRPC vs pts who did not. Results: M1 CRPC pts initially diagnosed with de novo mHSPC (n = 199) or nmHSPC (n = 254) were included; median age: 70.0 vs 73.0 years, duration from initial PC diagnosis to baseline mCRPC visit: 1.62 vs 6.72 years, PSA at PC diagnosis: 113.1 vs 10.1 ng/mL, Gleason score: 9.0 vs 8.0, respectively. In the de novo mHSPC and nmHSPC groups, initial CRPC Tx was chemotherapy in 9.0% vs 5.9% of pts, novel hormonal therapy (enzalutamide or abiraterone) in 55.3% vs 59.1%, immunotherapy in 35.2% vs 42.9%, respectively. No differences were seen in rPFS or PSA progression (table). The de novo mHSPC group showed a trend toward shorter time to OI and significantly increased risk of mortality (37%) with 6.6 months shorter median survival vs nmHSPC. The subanalysis included 44 (22.1%) de novo mHSPC pts who received Tx intensification with ADT at initial diagnosis. A trend towards improved survival was seen in the Tx-intensified vs nonintensified subgroup (median time to death [95%CI] ; 47.7 months [22.18, NE] vs 37.3 months [28.35, 43.01] ). Conclusions: At mCRPC diagnosis, pts with de novo mHSPC have significantly higher mortality risk than pts with nmHSPC, indicating a need to delay progression of de novo mHSPC to mCRPC. The trend for improved survival benefit in pts with Tx-intensified de novo mHSPC further underlines the need for early Tx intensification. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.16_suppl.e17085
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
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  • 5
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    Baseline covariates impacting overall survival (OS) in a phase III study of men with bone metastases from castration-resistant prostate cancer.
    American Society of Clinical Oncology (ASCO) ; 2012
    In:  Journal of Clinical Oncology Vol. 30, No. 15_suppl ( 2012-05-20), p. 4642-4642
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. 4642-4642
    Abstract: 4642 Background: Prognostic models of OS in men with metastatic castrate-resistant prostate cancer (M+CRPC), have been limited. Here we present an analysis of baseline covariates associated with OS from an international phase 3 study that demonstrated superiority of denosumab over zoledronic acid for prevention of skeletal-related events (SRE) in this population (Fizazi et al., Lancet 2011;377:813-822). Methods: Patients had confirmed bone metastases (BM) from CRPC (a rising PSA despite castrate testosterone levels) and no prior bone anti-resorptive therapy. Proportional hazards modeling with various selection strategies was used to assess the prognostic significance of baseline covariates in multivariate analyses. Study-specified factors (previous SRE [Y vs N], PSA level [ 〈 10 vs ≥10 ng /mL]) and additional variables (Cook et al., Clin Cancer Res 2006;12:3361-3367; Halabi et al., J Clin Oncol 2003;21:1232-1237; Halabi et al., J Clin Oncol 2008;26:2544-2549) were explored. As no difference in OS was observed between treatment arms, analyses were performed using the pooled overall patient population. Results: Analyses included all randomized subjects with available baseline covariate data (n=1745). At the primary analysis date (median study duration 12.2 months), OS was 51%. Various selection strategies produced consistent results. In multivariate analysis, bone-specific alkaline phosphatase (BAP) ≥146 μg/L (p 〈 0.0001) and corrected urinary N-telopeptide (uNTx) 〉 50 nmol/mmol (p=0.0008) were associated with shorter OS, as were prior SRE (p=0.0002), PSA ≥10 ng /mL (p 〈 0.0001), visceral metastases (p=0.0002), greater time from either diagnosis to first BM or first BM to randomization (p 〈 0.0001 for both), ECOG performance status 2 vs. 0/1 (p=0.017), BPI-SF pain score 〉 4 (p 〈 0.0001), age (p=0.008), alkaline phosphatase 〉 143 U/L (p 〈 0.0001), and hemoglobin ≤128 g/L (p 〈 0.0001). Conclusions: Besides known factors previously associated with OS in men with CRPC (Halabi et al., 2003), we show that bone-associated covariates (pain, prior SRE, BAP, and uNTx) are also important and independent prognostic factors for OS.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2012.30.15_suppl.4642
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2012
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  • 6
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    Rate of occult metastases in patients (pts) with biochemically-recurrent prostate cancer (BRPC) from a phase 2 trial of sipuleucel-T and androgen deprivation therapy (STAND).
    American Society of Clinical Oncology (ASCO) ; 2017
    In:  Journal of Clinical Oncology Vol. 35, No. 15_suppl ( 2017-05-20), p. e16516-e16516
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 35, No. 15_suppl ( 2017-05-20), p. e16516-e16516
    Abstract: e16516 Background: Identifying occult metastases in men with BRPC is critical, as treatment depends on disease state (biochemical recurrence vs oligometastatic disease). It is prudent to investigate pts for metastases, even men with low prostate-specific antigen (PSA) levels, to select appropriate salvage, local or systemic treatments. We evaluated baseline parameters of BRPC pts with occult metastases identified during screening for STAND (phase 2, NCT01431391). Methods: STAND eligibility criteria included prostate cancer primary therapy and PSA doubling time (PSADT) ≤12 months. Pts with metastases were excluded. We compared pts with and without metastases. Results: Of 99 screened pts, 68 entered STAND with non-metastatic BRPC, 11 (11%) failed screening due to metastases and 20 (20%) due to other reasons. In this small sample, no baseline parameters were identified that clearly distinguished between pts with or without metastases. For pts with metastases vs STAND pts, median age was similar (66 vs 65 y); all were Caucasian. Baseline median (range) PSA levels were numerically higher (4.3 [1.7–141.7] vs 2.4 [0.3–47.8] ng/mL) and PSADT values were numerically shorter (3.5 [1.1–7.6] vs 5.1 [1.0–16.4] months) for pts with metastases vs STAND pts, respectively. The proportion of pts with PSA 〉 10 ng/dL was 29% vs 19%, or PSADT 〈 6 months was 80% vs 59% for pts with metastases vs STAND pts, respectively. Baseline lactate dehydrogenase, alkaline phosphatase and hemoglobin levels were similar between groups. Conclusions: A substantial proportion (11%) of BRPC pts with presumed non-metastatic disease had undiagnosed occult metastases at low PSA levels. Such pts may benefit from closer monitoring with improved imaging technology, continuous androgen deprivation therapy or potentially docetaxel. While more rigorous screening (even at low PSA levels) may be advantageous, identifying such pts is challenging as their baseline parameters may not differ significantly vs BRPC pts with no metastases. In the future, detection of oligometastatic disease is likely to increase due to more sensitive imaging modalities, thus, the BRPC state will be reduced. Clinical trial information: NCT01431391.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2017.35.15_suppl.e16516
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2017
    detail.hit.zdb_id: 2005181-5
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  • 7
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    TALAPRO-2: a placebo-controlled phase III study of talazoparib (TALA) plus enzalutamide (ENZA) for patients with first-line metastatic castration-resistant prostate cancer (mCRPC).
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. TPS5598-TPS5598
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. TPS5598-TPS5598
    Abstract: TPS5598 Background: TALA blocks poly(ADP-ribose) polymerase (PARP) activity and traps PARP on single-strand DNA breaks, preventing DNA damage repair (DDR) and causing death of cells with DDR alterations (eg BRCA1/2). a TALA has been approved in multiple countries as monotherapy for germline BRCA1/2-mutated human epidermal growth factor receptor 2-negative advanced breast cancer. ENZA is an androgen receptor (AR) inhibitor and an established therapy for mCRPC. As PARP activity has been shown to support AR function, inhibition of PARP is expected to reduce AR signaling and increase sensitivity to AR-directed therapies. In addition, AR blockade downregulates homologous recombination repair gene transcription which induces ‘ BRCAness ’. Therefore, combining TALA with ENZA in mCRPC may be efficacious regardless of DDR alterations. TALAPRO-2 (NCT03395197) is a Phase III, 2-part study to evaluate efficacy, safety, pharmacokinetics, and patient-reported outcomes (PROs) of TALA combined with ENZA. Methods: Enrollment goal is 1037 patients (19 patients, part 1 dose-finding; 1,018 patients, part 2 placebo-controlled). Key eligibility criteria: age ≥18 years; asymptomatic/mildly symptomatic mCRPC; ECOG performance status ≤1; metastatic disease (no brain metastases); and no prior life-prolonging systemic therapy for nonmetastatic CRPC or mCRPC. Prior therapies (excluding novel AR inhibitors) in the castration-sensitive (CSPC) setting are allowed. ADT must continue throughout the study. The randomized double-blind portion (part 2) will evaluate safety, efficacy, and PROs of TALA (0.5 mg QD) + ENZA (160 mg QD) vs placebo + ENZA (160 mg QD). Patients are stratified by prior novel hormonal therapy or docetaxel for CSPC (yes or no) and DDR alteration status (deficient vs nondeficient/unknown). The primary endpoint is radiographic progression-free survival (rPFS), defined as time to progression in soft tissue per RECIST v.1.1 or in bone per PCWG3 criteria by independent review or death. The key secondary endpoint is overall survival. Efficacy will be assessed radiographically every 8 weeks up to Week 25 and every 8–12 weeks thereafter. rPFS will be compared between the two arms by a 1-sided stratified log-rank test. Patient recruitment is ongoing in multiple regions including US, Europe/Eastern Europe, Israel, South America, South Africa, and Asia-Pacific region. a DDR alterations are defined as known/likely pathogenic variants or homozygous deletions. Funding: Pfizer Inc. Clinical trial information: NCT03395197 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.15_suppl.TPS5598
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
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  • 8
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    Association between patient-reported outcomes (PROs) and changes in prostate-specific antigen (PSA) in patients (pts) with advanced prostate cancer treated with apalutamide (APA) in the SPARTAN and TITAN studies.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 6_suppl ( 2022-02-20), p. 73-73
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 6_suppl ( 2022-02-20), p. 73-73
    Abstract: 73 Background: In phase 3 placebo (PBO)-controlled studies, addition of APA to androgen deprivation therapy (ADT) improved overall survival, resulted in rapid and deep PSA declines, and reduced risk of disease progression while preserving health-related quality of life (HRQoL) in nonmetastatic castration-resistant prostate cancer (nmCRPC; SPARTAN) and metastatic castration-sensitive prostate cancer (mCSPC; TITAN). This post hoc analysis evaluated the association of a deep PSA decline with PROs in these studies. Methods: Pts on ADT were randomized to APA (240 mg QD) or PBO: SPARTAN 2:1 (N = 1,207; APA n = 806), TITAN 1:1 (N = 1,052; APA n = 525). Each cycle was 28 d. PROs were assessed using Functional Assessment of Cancer Therapy-Prostate (FACT-P), Brief Pain Inventory-Short Form (BPI-SF; TITAN only), and Brief Fatigue Inventory (BFI; TITAN only) at baseline, specific cycles during study treatment, and post progression up to 1 yr. A landmark analysis at Month 3 evaluated association between deep PSA decline (≤ 0.2 ng/mL) and time to subsequent deterioration in PROs (defined as decrease ≥ 10 points FACT-P total, ≥ 3 points Physical Wellbeing, ≥ 30% baseline for BPI-SF worst pain, or ≥ 2 points for BFI worst fatigue). At time of the landmark analysis, only pts continuing treatment were included; all deep PSA responses after, and all PRO deterioration events before, were ignored. Time-to-event end points were analyzed by Kaplan-Meier method and Cox proportional hazards model. Results: Median treatment durations were 32.9 mo (SPARTAN) and 39.3 mo (TITAN). Per assessment, 〉 90% (SPARTAN, cycles 1-81) and 〉 50% (TITAN, cycles 1-33) of eligible pts completed FACT-P; BPI-SF and BFI, both 〉 62% (TITAN, cycles 1-33). Pts in either study who achieved PSA ≤ 0.2 ng/mL at Month 3 had a lower risk of deterioration in FACT-P total or Physical Wellbeing (Table). Pts in TITAN with PSA ≤ 0.2 ng/mL at Month 3 had a lower risk of BPI-SF worst pain intensity or BFI worst fatigue intensity progression (Table). Conclusions: Deep and rapid PSA responses with APA were associated with prolonged time to deterioration in HRQoL, FACT-P Physical Wellbeing, BPI-SF worst pain intensity, and BFI worst fatigue intensity in pts with advanced PC. Clinical trial information: NCT02489318 (TITAN); NCT01946204 (SPARTAN). [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.6_suppl.073
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
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  • 9
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    Plain language summary of the design of the TALAPRO-2 study comparing talazoparib and enzalutamide versus enzalutamide and placebo in men with metastatic castration-resistant prostate cancer
    Future Medicine Ltd ; 2022
    In:  Future Oncology Vol. 18, No. 27 ( 2022-09), p. 2979-2986
    Details
    In: Future Oncology, Future Medicine Ltd, Vol. 18, No. 27 ( 2022-09), p. 2979-2986
    Abstract: This summary describes the design of an ongoing research study (also known as a clinical trial) called TALAPRO-2. The TALAPRO-2 trial is testing the combination of two medicines called talazoparib and enzalutamide as a first treatment in adult men with metastatic castration-resistant prostate cancer. The study began in December 2017 and has enrolled 1037 adult men with metastatic castration-resistant prostate cancer from 26 countries. What is metastatic castration-resistant prostate cancer? Metastatic castration-resistant prostate cancer is a type of cancer that has advanced beyond the prostate and continues to grow even when testosterone levels in the blood are suppressed. Which medicines are being tested? The combination of talazoparib plus enzalutamide will be compared with enzalutamide plus placebo. Enzalutamide is approved to treat men with prostate cancer. Talazoparib is not approved to treat men with prostate cancer. A placebo does not contain any active ingredients and is also known as a sugar pill. What are the aims of the TALAPRO-2 trial? The TALAPRO-2 trial will find out if combining talazoparib with enzalutamide increases the length of time the men in the study live without their cancer getting worse compared with enzalutamide plus placebo. The study will also measure how long men in the study live and any side effects the men have while they are taking the study medicines. Researchers are also testing the DNA from the tumor cells of all men in the study to find out if they have faulty DNA repair genes. Clinical Trial Registration: NCT0339519 ( ClinicalTrials.gov )
    Type of Medium: Online Resource
    ISSN: 1479-6694 , 1744-8301
    URL: Article
    DOI: 10.2217/fon-2022-0389
    Language: English
    Publisher: Future Medicine Ltd
    Publication Date: 2022
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  • 10
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    Evaluation of sexual function on a randomized trial of a prostate rectal spacer.
    American Society of Clinical Oncology (ASCO) ; 2017
    In:  Journal of Clinical Oncology Vol. 35, No. 6_suppl ( 2017-02-20), p. 69-69
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 35, No. 6_suppl ( 2017-02-20), p. 69-69
    Abstract: 69 Background: The SpaceOAR phase 3 trial showed that a hydrogel spacer between the prostate and rectum decreased rectal dose and toxicity while improving bowel quality of life (QOL) after image guided prostate IMRT to 79.2 Gy. Here we evaluated dose to penile bulb as well as sexual function on this trial Methods: Sexual QOL was measured with the Expanded Prostate Cancer Index Composite (EPIC) by mean summary scores and the proportion of patients with a minimally important decline (MID) (11 points). Stratification was based on severe erectile dysfunction (ED)(EPIC 〈 = 60) vs not. The single question on “Erections sufficient for intercourse over the preceding 4 weeks” was also evaluated. Results: Median Follow-up was 37 months with 63% of men evaluable at 3 years. With spacer the dose to the penile bulb was reduced for mean (21 vs 11 Gy), Dmax (46 vs 36 Gy), and V10-V30 (all p 〈 0.05). Baseline sexual function was 53 (±24) with 54% having severe ED with no difference between arms (p 〉 0.1). At 3 years average EPIC score was 39.7 (± 23) and 82% had severe ED with no differences between arms (p 〉 0.1). At enrollment 42% had EPIC 〉 60 with average summary of 77 (±8.3) which at 3 years was 53 (±24.8). In this sub-group at 3 years a higher EPIC was observed on the Spacer arm (57.7 (±24.1) vs. 44.6 (± 24.4)) which met the threshold for an MID without statistical significance (p = 0.07). Based on MID and twice that there was a trend favoring Spacer with 53% vs 75% for 11-point decline (p = 0.064) and 41% vs 60% for 22 point decline (p = 0.11). A small number of these men were potent at baseline and evaluable both at baseline and 3 years (n = 49). Of these 37.5% in the Control arm had erections sufficient for intercourse at 3 years as compared to 66.7% (p = 0.07) in the Spacer arm. Power analysis revealed 35% power to detect a change of 11 points between arms and 27% power to detect a difference of 22 points. Conclusions: The use of a hydrogel spacer decreased dose to the penile bulb with a suggestion of a clinically significant improvement in patient reported sexual function and potency. These did not achieve statistical significance potentially due to the high prevalence of ED at baseline and, therefore, the small evaluable sample size. Analysis of penile bulb dose and QOL is ongoing. Clinical trial information: NCT01538628.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2017.35.6_suppl.69
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2017
    detail.hit.zdb_id: 2005181-5
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