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

Phase 2RecruitingNCT05557604

Regina Elena Cancer Institute146 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

146

Conditions

Prostate Cancer

Interventions

DecapeptylDRUG

STAD androgen deprivation

Eligibility

Sex: MALEMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (3)

Ifo Regina elena

Rome, Lazio, Italy

RECRUITING

ifo Regina Elena

Rome, RM, Italy

RECRUITING

Regina Elena National Cancer Institute

Rome, Italy

RECRUITING

Outcomes

Primary Outcomes

3-yr bNED survival

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.

Time frame: 3 years

Central Contacts

Giuseppe Sanguineti, Professor

CONTACT

0652663015 giuseppe.sanguineti@ifo.it

Data from ClinicalTrials.gov

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