NCT06369610Active, not recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 110 (actual)
- First submitted
- 12 Apr 2024
- Start date
- 22 Apr 2024
- Primary completion date
- 29 Jul 2028
- Lead sponsor
- Mayo Clinic
- Diseases
- Prostate cancer
- NCT number
- NCT06369610
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 110
- From 22 Apr 2024 to the primary completion date, 29 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous pelvic radiation
- Prior androgen suppression therapy for prostate cancer for more than 6 months
- Prior systemic chemotherapy for prostate cancer
- 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)
Other illness
- 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)
- 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 congestive heart failure (CHF) within the last 6 months
Lab values
- 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)
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Arizona Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.