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

Launched by MAYO CLINIC · Apr 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat high-risk prostate cancer using less hormone therapy combined with radiation. The goal is to see if giving fewer hormone treatments, based on the patient's specific risk factors, is just as effective as the standard approach that uses more hormone therapy. Hormone therapy helps lower testosterone levels in the body, which can stop cancer cells from growing, while radiation therapy uses high-energy rays to kill cancer cells and shrink tumors. By focusing on a personalized treatment approach, researchers hope to improve outcomes for patients with oligometastatic prostate cancer, which means their cancer has spread to a limited number of areas.

To participate in this trial, patients need to be at least 18 years old and have been diagnosed with high-risk prostate adenocarcinoma that meets certain criteria, such as specific tumor grades or levels of prostate-specific antigen (PSA). Participants will undergo the new treatment approach and will be closely monitored throughout the study. It's important to note that certain health conditions or previous treatments may exclude someone from joining, so potential participants should discuss their medical history with their doctor. This trial is currently recruiting, and those interested should consider speaking with their healthcare provider for more information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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