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

Recruiting now · Phase 2

Conditions studied: Prostate Cancer

In brief

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

Key facts

Study ID

NCT05557604

Run by

Regina Elena Cancer Institute

People needed

146

Starts

2021-02-02

Expected to finish

2027-02-02

Last updated by the study team

2022-09-28

Who can join

Age: 18 and older, up to 90. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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

Where it is running

• Ifo Regina elena — Rome, Lazio, Italy (enrolling)
• ifo Regina Elena — Rome, RM, Italy (enrolling)
• Regina Elena National Cancer Institute — Rome, Italy (enrolling)

Full record on ClinicalTrials.gov

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