Prostate Cancer Clinical Trial
Official title:
Stereotactic Prostate Radiotherapy With or Without Androgen Deprivation Therapy, a Phase III, Multi-institutional Randomized-controlled Trial. The SPA 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 risk disease, results of the combination therapy are even more clear. Prostate SRT has been endorsed as option for primary radical treatment for prostate cancer. In such patients, the benefit of ADT is still unknown and the decision is left to clinical judgement. For these reasons, it seems to be relevant to propose a randomized, open label, phase III clinical trial of prostate SBRT + 6 months ADT versus prostate SBRT alone in intermediate unfavorable and a subgroup of high risk prostate cancer patients.
n/a
| NCT number | NCT05019846 |
| Study type | Interventional |
| Source | Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia |
| Contact | Marco Lorenzo Bonù, MD |
| Phone | +390303995285 |
| [email protected] | |
| Status | Recruiting |
| Phase | Phase 3 |
| Start date | September 30, 2021 |
| Completion date | December 1, 2029 |
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