Comparing two types of radiation therapy for recurrent or limited spread prostate cancer
Randomized Phase III Trial of SBRT Versus Hypofractionated Radiotherapy for Salvage of Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma After Radical Prostatectomy
This study is testing whether a new type of radiation therapy called SBRT is just as good as a different radiation treatment for men with recurring or limited prostate cancer, while also looking at side effects and quality of life.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 118 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 6 sites (Scottsdale, Arizona and 5 other locations) |
| Trial ID | NCT06205316 on ClinicalTrials.gov |
What this trial studies
This phase III trial evaluates the effectiveness and side effects of stereotactic body radiation therapy (SBRT) versus hypofractionated radiotherapy in patients with biochemically recurrent or oligometastatic prostate adenocarcinoma. The study aims to determine if SBRT is as effective as hypofractionated therapy in minimizing treatment-related complications, particularly genitourinary and gastrointestinal toxicities. Participants will undergo radiation therapy and be monitored for disease-free survival, quality of life, and other clinical outcomes over a period of five years. The trial includes comprehensive assessments of treatment impact on both cancer progression and patient well-being.
Who should consider this trial
Good fit: Ideal candidates include men aged 18 and older with histologically confirmed prostate adenocarcinoma that has recurred or spread to a limited number of sites.
Not a fit: Patients who have had previous pelvic radiation or prior androgen deprivation therapy for prostate cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and equally effective treatment option for patients with recurrent or oligometastatic prostate cancer.
How similar studies have performed: Other studies have shown promising results with SBRT, suggesting it may be a viable alternative to traditional radiation therapies, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion 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 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 Criteria: * 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
Where this trial is running
Scottsdale, Arizona and 5 other locations
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States (Recruiting)
- Mayo Clinic Health System in Albert Lea — Albert Lea, Minnesota, United States (Not_yet_recruiting)
- Mayo Clinic Health System - Mankato — Mankato, Minnesota, United States (Not_yet_recruiting)
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Not_yet_recruiting)
- Mayo Clinic Health System-Eau Claire Clinic — Eau Claire, Wisconsin, United States (Not_yet_recruiting)
- Mayo Clinic Health System-Franciscan Healthcare — La Crosse, Wisconsin, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Carlos E. Vargas, MD — Mayo Clinic
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.