OncoMatch/Clinical Trials/NCT05019846
SRT Versus SRT+ADT in Prostate Cancer
Is NCT05019846 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Triptorelin Embonate and Bicalutamide 50 mg for prostate cancer.
Treatment: Triptorelin Embonate · Bicalutamide 50 mg — To clarify the role of short-term Androgen deprivation therapy (ADT) in the context of intermediate unfavorable and a subclass of high-risk patients treated with prostate Stereotactic radiotherapy (SRT). In intermediate unfavorable risk group, when choosing standard external beam radiotherapy, short term ADT is superior in terms of biochemical disease free survival (bDFS) to EBRT alone. In high risk disease, results of the combination therapy are even more clear. Prostate SRT has been endorsed as option for primary radical treatment for prostate cancer. In such patients, the benefit of ADT is still unknown and the decision is left to clinical judgement. For these reasons, it seems to be relevant to propose a randomized, open label, phase III clinical trial of prostate SBRT + 6 months ADT versus prostate SBRT alone in intermediate unfavorable and a subgroup of high risk prostate cancer patients.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Required: Stage INTERMEDIATE UNFAVORABLE GROUP (D'AMICO/NCCN), HIGH RISK GROUP SUBCLASS (D'AMICO/NCCN), CT2B, CT2C, CT3A (D'Amico/NCCN)
Excluded: Stage CT3B, PELVIC LYMPH NODE INVOLVEMENT
Grade: Grade group 2Grade group 3ISUP group 4 (GS 4+4, 3+5, 5+3) (ISUP/Grade group)
Patients belonging to intermediate unfavorable group according to the D'Amico/NCCN risk group classification: -Grade group 3 or/and -2-3 risk factors for intermediate category (PSA 10-20 ng/ml/ Grade group 2-3/ cT2b cT2c) or/and -biopsy cores positive ≥50%. Patients belonging to a subclass of high risk group according to the D'Amico/NCCN risk group classification: -ISUP group 4 (GS 4+4, 3+5, 5+3) or -cT3a stage or -PSA>20. cT4a, cT3b or pelvic lymph node involvement [excluded].
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: androgen deprivation therapy
Exception: excluding 5alpha reductase inhibitors
Prior androgen deprivation therapy (excluding 5alpha reductase inhibitors)
Cannot have received: any prior active treatment for prostate cancer
Exception: patients on previous active surveillance are eligible if inclusion criteria are met
Any prior active treatment for prostate cancer; patients on previous active surveillance are eligible if inclusion criteria are met
Cannot have received: pelvic radiation therapy
Previous pelvic RT
Cannot have received: prostate surgery
Exception: other than TURP (at least 6 weeks prior to start of SBRT)
Previous prostate surgery other than TURP (at least 6 weeks prior to start of SBRT)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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