Risk Stratified De-escalated Hormone Therapy With Radiation Therapy for the Treatment of Prostate Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

This phase II trial tests how well risk based de-escalated hormone therapy (i.e., fewer treatments) with radiation works in treating patients with prostate cancer. Androgen deprivation therapy (ADT), such as gonadotropin-releasing hormone analogs (LHRH) and abiraterone acetate (Zytiga), lower the amount of the male hormone, testosterone, made by the body. This may help kill or stop the growth of tumor cells that need testosterone to grow. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Research has shown that long-term ADT is beneficial for patients with high-risk prostate cancer. However, there are few studies that determine ADT treatment based on risk factors. Giving risk based de-escalated ADT with radiation therapy may be as effective as giving more ADT in treating high-risk prostate cancer.

Eligibility criteria

Qualifiers

Histologically confirmed high risk prostate adenocarcinoma

Pathologic stages T1c-T4, N0-Nx-N1, M0-1 as staged by the pathology report (AJCC Criteria 8th Edition [Ed].)

One or more high risk features including Gleason 8-10, T3-T4, prostate specific antigen (PSA) ≥ 20

Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Disqualifiers

Previous pelvic radiation

Prior androgen suppression therapy for prostate cancer for more than 6 months

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

Trial design

Treatments tested in this trial

  • Abiraterone Acetate
  • Biospecimen Collection
  • Computed Tomography
  • Gonadotropin-releasing Hormone Analog
  • Magnetic Resonance Imaging
  • Positron Emission Tomography
  • Questionnaire Administration
  • Radiation Therapy

Treatment groups

110 Participants
are divided into 3 treatment groups

Sponsors and collaborators