RecruitingPhase 2NCT06369610

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

Risk Stratified De-Escalated De-Intensified Treatment for High Risk Prostate Cancer Patients Based on Pathologic Criteria, Genetic Score, and Biologic Imaging

Sponsor

Mayo Clinic

Enrollment

110 participants

Start Date

Apr 22, 2024

Study Type

INTERVENTIONAL

Conditions

Prostate Adenocarcinoma Oligometastatic Prostate Carcinoma

Summary

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

Min Age: 18 Years

Inclusion Criteria8

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
Patients must sign institutional review board (IRB) approved study specific informed consent
Patients must complete all required pre-entry tests
Patients must be at least 18 years old
Oligometastatic prostate cancer defined as disease in up to 5 distant or regional areas (group 3 only)

Exclusion Criteria9

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
History of proximal urethral stricture requiring dilatation
Current and continuing anticoagulation with warfarin sodium (Coumadin), heparin, low-molecular weight heparin, clopidogrel bisulfate (Plavix), or equivalent (unless it can be stopped to manage treatment related toxicity, to have a biopsy if needed, or place markers)
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)
Evidence of any other cancer within the past 5 years and \< 50% probability of a 5 year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed)
History of myocardial infarction or decompensated congestive heart failure (CHF) within the last 6 months