SRT Versus SRT+ADT in Prostate Cancer
Recruiting
Phase 3
Interventional Study
Prostate Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 80
- Sex
- Male
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 310 (estimated)
- Sponsor
- Marco Lorenzo Bonu · Other
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About This Trial
To clarify the role of short-term Androgen deprivation therapy (ADT) in the context of intermediate unfavorable and a subclass of high-risk patients treated with prostate Stereotactic radiotherapy (SRT).
In intermediate unfavorable risk group, when choosing standard external beam radiotherapy, short term ADT is superior in terms of biochemical disease free survival (bDFS) to EBRT alone. In high r…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Histological confirmation of prostate acinar adenocarcinoma with a minimum of 10 biopsy cores taken
* Prostate protocol MRI for local staging
* Patients belonging to intermediate unfavorable group according to the D'Amico/NCCN risk group classification:
* -Grade group 3 or/…
Contacts