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NCT05557604RecruitingPhase 2

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

Sbrt±sTad for Unfavorable iNtermediate rIsk/High Risk Prostate caNcer (STUNNIN): A Randomized Phase II Study

Source: ClinicalTrials.gov · Last updated 28 Sept 2022 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
146 (estimated)
First submitted
23 Sept 2022
Start date
2 Feb 2021
Primary completion date
2 Feb 2024
Lead sponsor
Regina Elena Cancer Institute
NCT number
NCT05557604

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 146
  • From 2 Feb 2021 to the primary completion date, 2 Feb 2024
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other

  • Impossibility to undergo MRI of the prostate
  • Contraindication to short term AD
  • Prostate volume \>90cc

Who the study is looking for

  • 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;

Age in the registry: 18 years to 90 years · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Regina Elena National Cancer Institute
Coordinator of this site? Confirm its status
RomeItalyRecruiting
Ifo Regina Elena
Coordinator of this site? Confirm its status
RomeItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.