SBRT Versus Hypofractionated Radiotherapy for Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma

Launched by MAYO CLINIC · Jan 4, 2024

Keywords

ClinConnect Summary

This clinical trial is comparing two types of radiation therapy for men with prostate cancer that has either come back after treatment or spread to a few other places in the body. The trial is specifically looking at stereotactic body radiation therapy (SBRT), which targets tumors very precisely, versus hypofractionated radiotherapy, which delivers higher doses of radiation over a shorter time. The goal is to see if SBRT can be just as effective as the other treatment but with fewer side effects and a shorter treatment schedule.

To participate in this study, men must be at least 18 years old and have been diagnosed with prostate adenocarcinoma that meets certain criteria. This includes having specific cancer stages and a certain level of a blood marker called PSA after surgery. Participants will receive either SBRT or hypofractionated therapy, and they can expect regular check-ups to monitor their health throughout the trial. It’s important to note that some patients may not qualify if they have had previous radiation treatments or certain medical conditions.

Gender

MALE

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 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