Actively Recruiting
Risk Stratified De-escalated Hormone Therapy With Radiation Therapy for the Treatment of Prostate Cancer
Led by Mayo Clinic · Updated on 2025-11-14
110
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Risk Stratified De-escalated Hormone Therapy With Radiation Therapy for the Treatment of Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed high risk prostate adenocarcinoma
- Pathologic stages T1c-T4, N0-Nx-N1, M0-1 as staged by pathology report (AJCC Criteria 8th Edition)
- One or more high risk features including Gleason 8-10, T3-T4, PSA 20
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Signed informed consent approved by institutional review board
- Completion of all required pre-entry tests
- At least 18 years old
- Oligometastatic prostate cancer with up to 5 distant or regional areas (group 3 only)
You will not qualify if you...
- Previous pelvic radiation
- Prior androgen suppression therapy for prostate cancer exceeding 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 allowed)
- Prior systemic chemotherapy for prostate cancer
- History of proximal urethral stricture requiring dilatation
- Current continuous anticoagulation with warfarin, heparin, low-molecular weight heparin, clopidogrel, or equivalent unless it can be stopped for treatment-related toxicity management
- Major medical, addictive, or psychiatric illness preventing consent or treatment completion (consent by legal representative not permitted)
- Other cancer within past 5 years with less than 50% 5-year survival probability (except basal cell or non-invasive squamous cell skin cancer)
- History of myocardial infarction or decompensated heart failure within last 6 months
AI-Screening
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Trial Site Locations
Total: 1 location
1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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