NCT06369610 · Mayo Clinic
Risk Stratified De-escalated Hormone Therapy With Radiation Therapy for the Treatment of Prostate Cancer
What this study 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.
View original scientific description
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.
Interventions
DRUG
Abiraterone Acetate
Given abiraterone acetate
PROCEDURE
Biospecimen Collection
Undergo blood sample collection
PROCEDURE
Computed Tomography
Undergo CT
BIOLOGICAL
Gonadotropin-releasing Hormone Analog
Given SC or IM
PROCEDURE
Magnetic Resonance Imaging
Undergo MRI
PROCEDURE
Positron Emission Tomography
Undergo PET
OTHER
Questionnaire Administration
Ancillary studies
RADIATION
Radiation Therapy
Undergo radiation therapy
Primary outcome measures
Hormonal domain scores
Time frame: At baseline and up to 2 years
Measured by the Expanded Prostate Cancer Index Composite. Comparison will be made using a one-sided, paired-difference t-test, with a Type I error rate of 0.025.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Scottsdale, Arizona
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 14, 2025 · Source of record for eligibility and locations