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

Sponsor
Regina Elena Cancer Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05557604
Collaborator
(none)
146
3
2
72
48.7
0.7

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
146 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
prospective, open, randomized phase 2 trialprospective, open, randomized phase 2 trial
Masking:
Single (Investigator)
Masking Description:
Subjects who meet all study eligibility criteria will be randomly assigned in a 1:1 ratio. Randomization is centralized at the promoter and takes place according to a specific procedure (in attachment). The randomization schedule will be generated by an independent group of the promoter. Patient study number and result of randomization will be given immediately by email.
Primary Purpose:
Supportive Care
Official Title:
Sbrt±sTad for Unfavorable iNtermediate rIsk/High Risk Prostate caNcer (STUNNIN): A Randomized Phase II Study
Actual Study Start Date :
Feb 2, 2021
Anticipated Primary Completion Date :
Feb 2, 2024
Anticipated Study Completion Date :
Feb 2, 2027

Arms and Interventions

Arm Intervention/Treatment
No Intervention: arm 1

SBRT alone 38 GY in 4 fractions

Experimental: arm 2

SBRT along with short course (6 months) androgen deprivation (STAD)

Drug: Decapeptyl
STAD androgen deprivation
Other Names:
  • Enantone
  • Outcome Measures

    Primary Outcome Measures

    1. 3-yr bNED survival [3 years]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ifo Regina elena Rome Lazio Italy 00144
    2 ifo Regina Elena Rome RM Italy 00144
    3 Regina Elena National Cancer Institute Rome Italy 00144

    Sponsors and Collaborators

    • Regina Elena Cancer Institute

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Giuseppe Sanguineti, Professore, Regina Elena Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT05557604
    Other Study ID Numbers:
    • RS1399/20(2384) PU
    First Posted:
    Sep 28, 2022
    Last Update Posted:
    Sep 28, 2022
    Last Verified:
    Sep 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Giuseppe Sanguineti, Professore, Regina Elena Cancer Institute
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 28, 2022