Sbrt±sTad for Unfavorable iNtermediate rIsk/High Risk Prostate caNcer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Decapeptyl.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: 18 years — 90 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Sbrt±sTad for Unfavorable iNtermediate rIsk/High Risk Prostate caNcer (STUNNIN): A Randomized Phase II Study
Overview
This is a prospective, open, randomized phase II trial.
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.
Interventions
- Drug Decapeptyl
STAD androgen deprivation
Primary outcome measures
- 3-yr bNED survival [Time frame: 3 years]
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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Italy · 3 centers
- Ifo Regina elena — Rome
- ifo Regina Elena — Rome
- Regina Elena National Cancer Institute — Rome
Identifiers
NCT: NCT05557604 · RS1399/20(2384) PU