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

Last updated: September 23, 2022
Sponsor: Regina Elena Cancer Institute
Overall Status: Active - Recruiting

Phase

2

Condition

Prostate Cancer

Urologic Cancer

Prostate Disorders

Treatment

N/A

Clinical Study ID

NCT05557604
RS1399/20(2384) PU
  • Ages 18-90
  • Male

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Previous local treatment of the prostate with surgery (radical prostatectomy orcryotherapy)
  • 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

Total Participants: 146
Study Start date:
February 02, 2021
Estimated Completion Date:
February 02, 2027

Study 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.

Connect with a study center

  • Ifo Regina elena

    Rome, Lazio 00144
    Italy

    Active - Recruiting

  • ifo Regina Elena

    Rome, RM 00144
    Italy

    Active - Recruiting

  • Regina Elena National Cancer Institute

    Rome, 00144
    Italy

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.