Sbrt±sTad for Unfavorable iNtermediate rIsk/High Risk Prostate caNcer

Phase 2

Recruiting

• Conditions: Prostate Cancer
• Interventions: Drug: Decapeptyl

• Registration Number: NCT05557604
• Lead Sponsor: Regina Elena Cancer Institute

Brief Summary

This is a prospective, open, randomized phase II trial.

Detailed Description

Patients will be randomized between SBRT alone (38 Gy in 4 fractions) or SBRT (same schedule) along with short course (6 months) androgen deprivation (STAD). All patients will be treated by intensity modulated radiotherapy. Regarding the combined modality approach, SBRT has to start within 3 months from the first injection of LHRH analogue.

Study Timeline

• Study Start: 2021-02-02
• Status Verified: 2022-09
• Study First Submitted: 2022-09-23
• Study First Submitted QC: 2022-09-23
• Last Update Submitted: 2022-09-23
• Study First Posted: 2022-09-28
• Last Update Posted: 2022-09-28
• Primary Completion: 2024-02-02
• Study Completion: 2027-02-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 146

Inclusion Criteria

• Histologically proven prostate adenocarcinoma
• IR or HR in the NCCN definition
• N0M0 at staging with choline or (preferably) PSMA PET-CT;
• ECOG performance status between 0 and 2;

Exclusion Criteria

• Previous local treatment of the prostate with surgery (radical prostatectomy or cryotherapy)
• Previous radiotherapy to the pelvis
• Previous chemotherapy for malignancy in past 5 years
• Impossibility to implant fiducials for tracking purposes
• Impossibility to undergo MRI of the prostate
• Contraindication to short term AD
• Prostate volume >90cc

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
arm 2	Decapeptyl	SBRT along with short course (6 months) androgen deprivation (STAD)

Primary Outcome Measures

Name	Time	Method
3-yr bNED survival	3 years	The primary objective of the study is 3-yr bNED survival. If bNED survival is not significantly different between the two experimental arms, the one without AD will be chosen in a future comparison with the standard of care.

Trial Locations

Locations (3)

Ifo Regina elena; 🇮🇹 Rome, Lazio, Italy

Regina Elena National Cancer Institute; 🇮🇹 Rome, Italy

ifo Regina Elena; 🇮🇹 Rome, RM, Italy