Stereotactic Body Radiotherapy Versus Hypofractionated Radiotherapy for Salvage of Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma After Radical Prostatectomy

Overview

About this study

The purpose of this study is to determine if salvage stereotactic body radiotherapy (SBRT) is non-inferior to moderately hypofractionated radiation therapy (HFRT) regarding treatment related rates of genitourinary (GU) and gastrointestinal (GI) Grade 3 or higher within 2-years.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 (AJCC Criteria 8th Ed.).
  • PSA post radical prostatectomy ≥ 0.1 and < 2.0 ng/mL within 90 days prior to enrollment, obtained at least 6 weeks after surgery.
  • ECOG performance status 0-2 assessed within 90 days of enrollment.
  • Patients must sign IRB approved study specific informed consent.
  • Patients must complete all required pre-entry tests listed in section 4.0 within the specified time frames.
  • Patients must be able to start treatment (ADT or radiation) within 120 days of study registration.
  • Patients must be at least 18 years old.

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 CHF within the last 6 months.
  • On a transplant list.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 8/31/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Carlos Vargas, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available