Sbrt±sTad for Unfavorable iNtermediate rIsk/High Risk Prostate caNcer
Recruiting · NCT05557604 · Interventional (participants receive a specific treatment) · Lead sponsor: Regina Elena Cancer Institute
View the official record on ClinicalTrials.gov →Interventions studied
Decapeptyl
What this trial is about
This is a prospective, open, randomized phase II trial.
Who can take part
Age range
18 Years to 90 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
3 locations listed.
- Regina Elena National Cancer Institute - Rome, Italy
- Ifo Regina elena - Rome, Lazio, Italy
- ifo Regina Elena - Rome, RM, Italy