Status:
RECRUITING
SBRT Versus Hypofractionated Radiotherapy for Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma
Lead Sponsor:
Mayo Clinic
Conditions:
Biochemically Recurrent Prostate Carcinoma
Oligometastatic Prostate Carcinoma
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
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 bac...
Detailed Description
PRIMARY OBJECTIVE: I. To determine if salvage SBRT is non-inferior to moderately hypofractionated radiation therapy regarding treatment related rates of genitourinary (GU) and gastrointestinal (GI) g...
Eligibility Criteria
Inclusion
- 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 ng/mL ≤ 90 days prior to enrollment, obtained ≥ 6 weeks after surgery
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 assessed ≤ 90 days of enrollment
- Patients must sign institutional review board (IRB) approved study specific informed consent
- Patients must complete all required pre-entry tests within the specified time frames
- Patients must be able to start treatment (ADT or radiation) ≤ 120 days of study registration
- Patients must be ≥ 18 years old
- Prostate cancer up to oligometastatic disease, up to 5 sites
Exclusion
- Previous pelvic radiation
- Prior androgen deprivation therapy for prostate cancer and PSA ≥ 0.1 ng/mL
- Active rectal diverticulitis, Crohn's disease affecting the rectum, or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed)
- Prior systemic chemotherapy for prostate cancer
- History of proximal urethral stricture requiring dilatation
- Major medical, addictive, or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (Consent by legal authorized representative is not permitted for this study)
- History of myocardial infarction or decompensated congestive heart failure (CHF) within the last 6 months
- On a transplant list
- More than oligometastatic disease \> 5 metastatic sites
Key Trial Info
Start Date :
January 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 22 2030
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT06205316
Start Date
January 22 2024
End Date
January 22 2030
Last Update
June 11 2025
Active Locations (6)
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1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
2
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, United States, 56007
3
Mayo Clinic Health System - Mankato
Mankato, Minnesota, United States, 56001
4
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905