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Clinical Trials/CTIS2024-511886-12-00
CTIS2024-511886-12-00
Active, not recruiting
Phase 1

Sbrt±sTad for Unfavorable iNtermediate rIsk/high-risk prostate cancer (STUNNIN): A Randomized Phase II Study - 2020-004195-17

I.F.O. Istituti Fisioterapici Ospitalieri0 sites146 target enrollmentFebruary 15, 2024

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
I.F.O. Istituti Fisioterapici Ospitalieri
Enrollment
146
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 15, 2024
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
Male

Investigators

Eligibility Criteria

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

  • T3b disease according to the 8th AJCC classification; \- PSA\>20 ng/ml at any time point \- Gleason Score of 9 or 10 (Grade Grouping V) \- 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

Outcomes

Primary Outcomes

Not specified

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