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  • 1
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    Stereotactic Body Radiation Therapy and Abiraterone Acetate for Patients Affected by Oligometastatic Castrate-Resistant Prostate Cancer: A Randomized Phase II Trial (ARTO)
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 36 ( 2023-12-20), p. 5561-5568
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 36 ( 2023-12-20), p. 5561-5568
    Abstract: ARTO (ClinicalTrials.gov identifier: NCT03449719 ) is a multicenter, phase II randomized clinical trial testing the benefit of adding stereotactic body radiation therapy (SBRT) to abiraterone acetate and prednisone (AAP) in patients with oligometastatic castrate-resistant prostate cancer (CRPC). MATERIALS AND METHODS All patients were affected by oligometastatic CRPC as defined as three or less nonvisceral metastatic lesions. Patients were randomly assigned 1:1 to receive either AAP alone (control arm) or AAP with concomitant SBRT to all the sites of disease (experimental arm). Primary end point was the rate of biochemical response (BR), defined as a prostate-specific antigen (PSA) decrease ≥50% from baseline measured at 6 months from treatment start. Complete BR (CBR), defined as PSA 〈 0.2 ng/mL at 6 months from treatment, and progression-free survival (PFS) were secondary end points. RESULTS One hundred and fifty-seven patients were enrolled between January 2019 and September 2022. BR was detected in 79.6% of patients (92% v 68.3% in the experimental v control arm, respectively), with an odds ratio (OR) of 5.34 (95% CI, 2.05 to 13.88; P = .001) in favor of the experimental arm. CBR was detected in 38.8% of patients (56% v 23.2% in the experimental v control arm, respectively), with an OR of 4.22 (95% CI, 2.12 to 8.38; P 〈 .001). SBRT yielded a significant PFS improvement, with a hazard ratio for progression of 0.35 (95% CI, 0.21 to 0.57; P 〈 .001) in the experimental versus control arm. CONCLUSION The trial reached its primary end point of biochemical control and PFS, suggesting a clinical advantage for SBRT in addition to first-line AAP treatment in patients with metastatic castration-resistant prostate cancer.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.23.00985
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
    detail.hit.zdb_id: 604914-X
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  • 2
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    Quality of life after radical treatment for muscle invasive bladder cancer: A systematic review and meta-analysis.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 6_suppl ( 2023-02-20), p. 489-489
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 6_suppl ( 2023-02-20), p. 489-489
    Abstract: 489 Background: Radical cystectomy (RC) with or without perioperative chemotherapy is considered the standard treatment option for Muscle invasive bladder cancer (MIBC), despite poor oncological outcomes. However, RC is often burdened by significant impact on quality of life (QoL); Continence preserving methods (e.g continent cutaneous urinary diversion and orthotopic neobladder-ONB), have been proposed as alternatives to improve the postoperative QoL, but real benefit of these approaches is questioned. Bladder sparing approach, such as trimodal therapy (TMT) emerged as an alternative to surgery. Aiming to assess the impact of these treatment options from the patients’ perspective, we undertook a systematic review and meta-analysis of literature, focusing on studies specifically reporting QoL data about each of the above mentioned approaches. Main purpose of this review is to compare available treatment options from the QoL point of view and highlight the potential advantage of a bladder sparing approach if compared to different postoperative urinary diversion methods. Methods: A systematic review was carried out including all prospective and retrospective studies enrolling patients treated with radical intent for non-metastatic MIBC from 1999 to 2021 (either RC or TMT). All studies included specifically reported QoL for one of the main treatment approaches explored (RC followed by ileal conduit urinary diversion-ICUD, ONB or TMT). Review was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement Results: Fifty studies were included in the final analysis, assessing QoL after RC followed by ICUD or ONB in 6 and 15 cases, respectively. Six studies addressed QoL after TMT. ICUD vs ONB and TMT vs ICUD/ONB comparisons were carried out in 21 and 1 studies, respectively. Pooled analysis for EORTC QLQ- C30 and BLM-30 questionnaires showed that ONB yielded a significant advantage if compared to ICUD only for Physical Functioning (pooled mean standardized difference -0.73 SD, p-value 0.019, I 2 =93%) and for Emotional Functioning (pooled mean standardized difference -0.16 SD, p-value 0.029, I 2 =0%). A trend in favour of higher mean reported values after TMT for Global Health Score, Physical Functioning and Role Functioning was found, if compared to both RC approaches. Conclusions: Significant benefit for ONB if compared to ICUD was detected only for specific subdomains of QoL questionnaires. No direct comparison with TMT is available, but data suggest advantage of this approach if compared to both reconstructive scenarios. These data should be used in clinical practice to help well informed patients decision about local treatment choice.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.6_suppl.489
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
    detail.hit.zdb_id: 604914-X
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  • 3
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    PRIMERA trial (NCT04188275), early survival results from a prospective trial exploring impact of circulating tumor cell detection in castrate resistant prostate cancer patients undergoing abiraterone or enzalutamide I line treatment.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 6_suppl ( 2022-02-20), p. 137-137
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 6_suppl ( 2022-02-20), p. 137-137
    Abstract: 137 Background: Circulating tumor cells (CTC) detection and androgen receptor splice variant 7 (ARV7) expression have been shown to be associated with worse clinical outcomes in metastatic castration resistant prostate cancer (mCRPC) patients undergoing androgen receptor targeted agents (ARTA) treatment, paving the way for alternative treatment options for patients with negative predictive factors. Full-length androgen receptor (ARFL), prostate specific membrane antigen and prostate specific antigen (PSA) may further help to refine prognostic models. In our institution, a prospective observational trial testing CTC detection in mCRPC undergoing ARTA treatment (PRIMERA trial, NCT04188275) terminated the planned enrollment in 2020. Here we present early results of the overall cohort. Methods: PRIMERA (NCT04188275) is a prospective, observational trial enrolling mCRPC patients undergoing ARTA treatment. All patients were treated with either abiraterone or enzalutamide in I line setting. Blood samples to detect CTCs were taken before starting ARTA treatment. Reverse transcription - quantitative real-time PCR (RT-qPCR) was used to determine the CTC expression of PSA, PSMA, AR and ARV7. PSA drop (defined as difference between baseline PSA at ARTA treatment start and PSA at nadir under treatment), progression free and overall survival (PFS and OS) and their correlation with CTC detection were reported. Explorative analysis about AR, PSA and PSMA expression in CTC+ patients were conducted. Results: Overall, 44 patients were included. CTC were detected at treatment start in 19 patients (43,2%), of whom 3(15,78%), 9(63,15%), 15(78,94%) and 14 (73.68%) patients expressed ARV7, ARFL, PSA and PSMA, respectively. Biochemical response was significantly improved in CTC+ vs. CTC- patients, with median PSA drop values of 18.5 vs 2.5 ng/ml (p=0.03). After a median follow up of 18 months, 22 (50%) patients progressed. PFS was significantly longer in CTC- patients (not reached vs 16 months, respectively, p=0.02). Eight (18.2%) patients died, a non-significant trend in terms of overall survival was detected in favor of CTC- patients (not reached vs 29 months, respectively, p=0.05). AR, PSA and PSMA expression in CTC+ had no significant impact on PSA drop, PFS or OS. Conclusions: PRIMERA trial confirmed the CTC detection predictive importance in mCRPC patients. Adequately powered studies will be needed to further explore CTC profiling in this setting. Clinical trial information: NCT04188275.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.6_suppl.137
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
    detail.hit.zdb_id: 604914-X
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  • 4
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    Three Months’ PSA and Toxicity from a Prospective Trial Investigating STereotactic sAlvage Radiotherapy for Macroscopic Prostate Bed Recurrence after Prostatectomy—STARR (NCT05455736)
    MDPI AG ; 2023
    In:  Cancers Vol. 15, No. 3 ( 2023-02-03), p. 992-
    Details
    In: Cancers, MDPI AG, Vol. 15, No. 3 ( 2023-02-03), p. 992-
    Abstract: Biochemical recurrences after radical prostatectomy (RP) can be managed with curative purpose through salvage radiation therapy (SRT). RT dose escalation, such as stereotactic RT (SSRT), may improve relapse-free survival in this setting. STARR trial (NCT05455736) is a prospective multicenter study including patients affected by macroscopic recurrence within the prostate bed after RP treated with SSRT. Recurrence was detected with a Choline or PSMA CT-PET. In the current analysis, the early biochemical response (BR) rate and toxicity profile after three months of follow-up were assessed. Twenty-five patients were enrolled, and data about BR and toxicity at three months after treatment were available for 19 cases. Overall, BR was detected after three months in 58% of cases. Four G1–G2 adverse events were recorded; no G ≥ 3 adverse events were detected. SSRT appears feasible and safe, with more than half of patients experiencing BR and an encouraging toxicity profile. The STARR trial is one of the few prospective studies aimed at implementing this promising treatment strategy in this scenario.
    Type of Medium: Online Resource
    ISSN: 2072-6694
    URL: Article
    DOI: 10.3390/cancers15030992
    Language: English
    Publisher: MDPI AG
    Publication Date: 2023
    detail.hit.zdb_id: 2527080-1
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  • 5
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    ARTO trial-(NCT03449719): Early results from a phase II randomized trial testing stereotactic body radiation therapy in patients with oligometastatic castration-resistant prostate cancer undergoing I line treatment with abiraterone acetate.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 6_suppl ( 2022-02-20), p. 100-100
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 6_suppl ( 2022-02-20), p. 100-100
    Abstract: 100 Background: ARTO (NCT03449719) is a multicentre, randomized trial started in January 2019 and currently running in 16 Italian centres, testing the benefit of adding stereotactic body radiation therapy (SBRT) to Abiraterone Acetate (AA) in oligometastatic Castrate Resistant Prostate Cancer (CRPC) patients. Seventy-nine per cent of the target accrual population has been currently enrolled. Here we present a report about early efficacy results of SBRT+AA combination. Methods: Data from patients with ≥ 6 months of follow up were reported. All patients were affected by oligometastatic CRPC, defined as ≤ 3 non-visceral metastatic lesions. Patients were randomized 1:1 to receive either AA alone (control arm) or associated with concomitant SBRT on all sites of disease (treatment arm). Primary endpoint of the trial is rate of biochemical response (BR, defined as a PSA decrease ≥ 50% from baseline measured within 6 months from treatment start). Complete biochemical response (CBR, defined as PSA at 6 months ≤ 0.2 ng/ml) is a secondary endpoint of the trial. Results: Overall, 123 patients have been currently enrolled in ARTO trial. To date, 98 patients had ≥ 6 months of follow-up and were evaluable for the present analysis. BR was detected in 75 (76.5%) patients (82.2% vs. 71.7% in treatment vs. control arm, respectively), with an unadjusted odds ratio (OR) equal to 1.83 (95% CI 0.69-4.82, p-value 0.22). After adjustment for baseline PSA and the number of metastatic sites ( 〉 1 vs. 1), the OR for BR was 2.23 (95% CI 0.74-6.73, p-value 0.15). CBR was detected in 36 (36.7%) patients (46.7% vs. 28.3% in treatment vs. control arm, respectively), with an unadjusted OR of 2.22 (95% CI 0.96-5.12, p-value 0.06), and an adjusted OR of 2.31 (95% CI 0.90-5.92, p-value 0.08). In multivariable models, baseline PSA and the number of metastatic sites 〉 1 were non-statistically associated with CBR, with OR equal to 0.92 (95% CI 0.85-1.01, p-value 0.06) and 1.20 (95% CI 0.46-3.09, p-value 0.71), respectively. Conclusions: Results showed promising efficacy of SBRT+AA combination if compared to systemic treatment alone for oligometastatic CRPC, OR for BR and CBR were doubled in treatment vs. control arm, even if statistical significance is not yet reached. Interestingly, baseline burden of disease seems to predict increased outcome after SBRT, suggesting that selection criteria for local treatment may be further refined. Complete results for primary endpoint are awaited in 2022, after enrollment and follow-up completion of whole cohort, and may confirm these early outcomes in a larger population. Clinical trial information: NCT03449719.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.6_suppl.100
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
    detail.hit.zdb_id: 604914-X
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  • 6
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    Impact of stereotactic body radiotherapy vs palliative radiotherapy on oncologic outcomes of patients with metastatic kidney cancer concomitantly treated with immune checkpoint inhibitors: a preliminary, multicentre experience
    Springer Science and Business Media LLC ; 2022
    In:  Clinical and Translational Oncology Vol. 24, No. 10 ( 2022-06-23), p. 2039-2043
    Details
    In: Clinical and Translational Oncology, Springer Science and Business Media LLC, Vol. 24, No. 10 ( 2022-06-23), p. 2039-2043
    Abstract: To explore the benefit yielded by radiotherapy (RT), we report a series of metastatic renal cell carcinoma (RCC) patients treated with concomitant RT plus Nivolumab. Methods/patients Patients undergoing Nivolumab treatment plus concomitant RT (ablative or palliative) were included. RT was defined Ablative if 〉 5 Gy/fraction were delivered. Results Ablative RT intent was the only independent predictor of both progression free and overall survival (HR 3.51, 95% CI 1.6–7.5, p  = 0.0012 and HR 2.8, 95% CI 0.99–8.07, p  = 0.05, respectively). Conclusion Ablative RT may improve oncologic outcomes in selected patients with metastatic RCC treated with Nivolumab as compared to palliative RT.
    Type of Medium: Online Resource
    ISSN: 1699-3055
    URL: Article
    DOI: 10.1007/s12094-022-02844-5
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
    detail.hit.zdb_id: 2420460-2
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  • 7
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    ARTO trial (NCT03449719), a randomized phase II trial enrolling oligometastatic castration-resistant prostate cancer patients treated with first-line abiraterone acetate with or without stereotactic body radiation therapy: Preliminary results comprehensive of biochemical outcomes and circulating tumor cells analysis.
    American Society of Clinical Oncology (ASCO) ; 2021
    In:  Journal of Clinical Oncology Vol. 39, No. 6_suppl ( 2021-02-20), p. 118-118
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 6_suppl ( 2021-02-20), p. 118-118
    Abstract: 118 Background: Androgen Receptor Targeted Agents (ARTA) represent one of the main treatment options for metastatic castrate resistant prostate cancer (mCRPC). Addition of stereotactic radiation therapy (SBRT) to ablate metastatic foci may improve clinical outcomes in oligometastatic setting. ARTO trial (NCT03449719) is a randomized phase II trial testing the benefit of upfront SBRT on all sites of metastatic disease in oligo-mCRPC patients undergoing I line therapy with Abiraterone Acetate (AA). In this preliminary analysis, we report results after 6 months of follow up, together with an exploratory analysis of androgen receptor splice variants (ARV7/ARFL) Prostate Specific Antigen (PSA) and Prostate Specific Membrane Antigen (PSMA) expression on Circulating Tumor Cells (CTCs) detected in this cohort of patients. Methods: 31 patients affected by oligo-mCRPC (defined as 〈 3 non-visceral metastatic lesions) were randomized to receive I line AA therapy with or without SBRT on all metastatic sites. Baseline blood samples to detect CTCs and evaluate their ARV7, ARFL, PSA and PSMA expression were taken before AA treatment start. Assessments comprehensive of clinical examination and serum PSA were performed every three months. Toxicity was assessed by the Common Terminology Criteria for Adverse Events toxicity scale (CTCAE v.4.03). Results: Thirteen and 18 patients were enrolled in the treatment and control arm, respectively. Nineteen metastatic lesions were treated with SBRT in the treatment arm. At 6 months, complete response (defined as a serum PSA level 〈 0.2 ng/dl) and biochemical response (defined as a PSA reduction 〉 50% if compared to baseline) were achieved in 6 vs 4 and in 10 vs 8 patients in the treatment vs control arm, respectively. One patient in the treatment arm died for other causes, 1 biochemical progression occurred in the control arm. No adverse events occurred in both arms of treatment. CTCs analysis was available for 10 patients, out of whom 4 were found positive for CTCs (1 and 3 from the treatment and control arm, respectively). ARV7 and ARFL were expressed in 1 patient from the control arm, PSMA was expressed in all CTC positive patients, PSA was expressed in 2 patients from the control and one from the treatment arm. Conclusions: SBRT+AA in oligo-mCRPC patients was safe and yielded promising biochemical results. CTCs detection in this selected cohort of oligo-mCRPC was lower if compared to historical data of unselected mCRPC patients. Data about ARV7, ARFL, PSA and PSMA expression represent an interesting snapshot of biomarker arrangement in this setting. Clinical trial information: NCT03449719.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2021.39.6_suppl.118
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2021
    detail.hit.zdb_id: 2005181-5
    detail.hit.zdb_id: 604914-X
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  • 8
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    Prospective assessment of AR splice variant and multi-biomarker expression on circulating tumor cells of mCRPC patients undergoing androgen receptor targeted agents: interim analysis of PRIMERA trial (NCT04188275)
    Springer Science and Business Media LLC ; 2022
    In:  Medical Oncology Vol. 39, No. 8 ( 2022-08)
    Details
    In: Medical Oncology, Springer Science and Business Media LLC, Vol. 39, No. 8 ( 2022-08)
    Type of Medium: Online Resource
    ISSN: 1559-131X
    URL: Article
    DOI: 10.1007/s12032-022-01756-2
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
    detail.hit.zdb_id: 2008172-8
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  • 9
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    Study protocol and preliminary results from a mono-centric cohort within a trial testing stereotactic body radiotherapy and abiraterone (ARTO-NCT03449719)
    Springer Science and Business Media LLC ; 2022
    In:  La radiologia medica Vol. 127, No. 8 ( 2022-08), p. 912-918
    Details
    In: La radiologia medica, Springer Science and Business Media LLC, Vol. 127, No. 8 ( 2022-08), p. 912-918
    Abstract: ARTO trial was designed to evaluate the difference in terms of outcomes between patients affected by oligo metastatic castrate resistant prostate cancer (mCRPC) treated with Abiraterone acetate and randomized to receive or not SBRT on all sites of disease. Here, we present a preliminary analysis conducted on patients enrolled at promoting institution. Objective To present a preliminary overview about population features, clinical outcomes, adverse events, quality of life and explorative translational research. Design, setting, and participants ARTO (NCT03449719) is a phase II trial including patients affected by oligo mCRPC, randomized to receive standard of care (GnRH agonist or antagonist plus abiraterone acetate 1000 mg and oral prednisone 10 mg daily) with or without SBRT on all metastatic sites of disease. All subjects have  〈  3 bone or nodal metastases. All patients are treated in I line mCRPC setting, no previous lines of treatment for mCRPC are allowed. Outcome measurements and statistical analysis Data about a mono-centric cohort of 42 patients enrolled are presented in the current analysis, with focus on baseline population features, PSA drop at 3 months, biochemical response, and quality of life outcomes. Descriptive statistics regarding translational research are also presented. Results and limitation Significant difference in terms of PSA drop at three months was not detected ( p  = 0.68). Biochemical response (PSA reduction  〉  50%) was reported in 73.7 versus 76.5% of patients in control vs SBRT arm, respectively ( p  = 0.84). All patients are alive. Progression occurred in 1 versus 0 patients in the control versus SBRT arm, respectively. After 3 months, an average decrease of 13 points in terms of Global Health Score was reported for the overall population. However, complete recovery was noticed at 6 months. Circulating tumor cells detection rate was 40%. Conclusions SBRT + Abiraterone treatment was safe and well tolerated, non-significant trend in terms of PSA drop and biochemical response at 3 months was detected in SBRT arm. Interestingly, CTCs detection in this selected cohort of oligo-mCRPC was lower if compared to historical data of unselected mCRPC patients.
    Type of Medium: Online Resource
    ISSN: 1826-6983
    URL: Article
    DOI: 10.1007/s11547-022-01511-7
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
    detail.hit.zdb_id: 2225828-0
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  • 10
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    Early biochemical outcomes following PSMA-guided approach for biochemical relapse after prostatectomy: PSICHE trial.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 6_suppl ( 2023-02-20), p. 137-137
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 6_suppl ( 2023-02-20), p. 137-137
    Abstract: 137 Background: Main approach for early biochemical relapse (BR) after radical prostatectomy (RP) is prostate bed salvage radiotherapy (SRT). PSICHE is a prospective trial aimed to explore oncological results of a 68Ga-PSMA-11 PET/CT tailored strategy based on a pre-defined treatment algorithm. We present results focusing on early biochemical outcomes after therapy. Biochemical response was defined as Complete (CBR) or Partial (PBR) if a PSA 〈 0.2 or 〈 50% of baseline was reached. Methods: Enrolled patients were affected by BR (defined as PSA 〉 0.2 ng/ml) after RP +/- postoperative SRT. PSA 〉 1 at recurrence or PSA persistence after surgery (PSA 〉 0.2 ng within 16 weeks from RP) were exclusion criteria. All patients underwent centralized 68Ga-PSMA PET/CT and treatment approach was performed according to predefined criteria. Observation and re-staging at further PSA progression were proposed to patients with negative PSMA and previous postoperative RT. Prostate bed SRT was proposed to all patients with negative staging or positive imaging within the prostate bed. Stereotactic body radiotherapy (SBRT) to all sites of disease was proposed to patients with pelvic nodal recurrence (nodal disease 〈 2 cm under aortic bifurcation) or oligometastatic disease ( 〈 3 non visceral metastatic lesions). Non oligometastatic disease was treated with Androgen deprivation therapy +/- other systemic treatment. Results: Enrollment started on 19/03/2021 and 104 patients have been enrolled, with a median baseline PSA of 0.39 ng/ml. Overall, PSMA results were negative/positive in prostate bed in 75 patients (72.1%), while pelvic nodal or extrapelvic metastatic disease were detected in 23 (22.1%) and 6 (5.76%) patients, respectively. Twenty-two patients were observed after re-staging and were excluded from the current analysis. Treatment provided was SRT, SBRT or ADT in 50 (48.1%), 29 (27.8%) and 3 (2.9%) patients, respectively. Data about biochemical response at 3 months after treatment were available for 53 patients. Of these, 33 (62.3%) had a PBR, out of whom CBR was detected in 29 (54.7%). Any reduction in PSA if compared to baseline was detected in 44 patients, for an overall biochemical response rate of 83%. Five patients had biochemical progression and underwent a second PSMA re-staging with distant metastases detection. Only 2 patients experienced G2 Genitourinary toxicity, no G2 Gastrointestinal toxicity was recorded. Chi square test did not detect impact of ISUP score ( 〈 or 〉 3) or time to recurrence (measured between surgery and biochemical relapse) on CBR rate. Conclusions: A PSMA targeted salvage treatment strategy offered promising results in terms of early biochemical response, with optimal toxicity profile, and avoided unnecessary overtreatment in this setting. Longer follow up is needed to explore biochemical relapse free and progression free survival after this approach. Clinical trial information: NCT05022914 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.6_suppl.137
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
    detail.hit.zdb_id: 604914-X
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