SBRT Versus Hypofractionated Radiotherapy for Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma
Recruiting
Phase 3
Interventional Study
Biochemically Recurrent Prostate Carcinoma
Oligometastatic Prostate Carcinoma
Recurrent Prostate Adenocarcinoma
Stage IIB Prostate Cancer AJCC v8
Stage IIC Prostate Cancer AJCC v8
Stage III Prostate Cancer AJCC v8
Stage IV Prostate Cancer AJCC v8
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 and older
- Sex
- Male
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 118 (estimated)
- Sponsor
- Mayo Clinic · Other
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About This Trial
This phase III trial tests the side effects of stereotactic body radiation therapy (SBRT) compared to hypofractionated radiotherapy for treating patients with prostate adenocarcinoma that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to a limited number of sites (oligometastatic). SBRT is a type of external radiation therapy t…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Histologically confirmed prostate adenocarcinoma at the time of surgery
* Pathologic stages T2-T3b, Nx or N0-1, M0-1 as staged by the pathology report (American Joint Committee on Cancer \[AJCC\] Criteria 8th edition \[Ed.\])
* PSA post radical prostatectomy ≥ 0.1 and \< 2.0 n…
Contacts