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Risk-Stratified Hormone and Radiation Therapy for Prostate Cancer

This study is looking at how well a risk-based approach to hormone therapy, combined with radiation, works for people with prostate cancer. The study uses abiraterone acetate (Zytiga) and gonadotropin-releasing hormone analogs (LHRH), which are medicines that lower testosterone to help stop cancer growth. Radiation therapy uses high-energy rays to kill cancer cells. The goal is to see if this approach helps patients recover their hormone-related quality of life. This study is for people with high-risk prostate cancer, aged 18 and older, who meet specific health criteria. The study plans to enroll 110 participants, but its current status is unclear.

Study design
This is a Phase II interventional study that plans to enroll 110 participants. Participants are assigned to one of three risk groups.
What's involved
You would undergo blood sample collection, CT scans, and MRI scans. You may also receive hormone therapy for up to 12 months and radiation therapy over 2-6 weeks. Your hormonal quality of life will be measured at baseline and up to 2 years.
Compensation
Not stated in the trial record.
Follow-up
Your hormonal quality of life will be measured up to 2 years. Other outcomes, such as toxicity and survival, will be followed for up to 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06369610

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Mayo Clinic
~110 participants
Updated 2025-11-14 on ClinicalTrials.gov
What's tested:Abiraterone AcetateBiospecimen CollectionComputed TomographyGonadotropin-releasing Hormone AnalogMagnetic Resonance ImagingPositron Emission Tomography

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Hormonal domain scores
Measured over At baseline and up to 2 years

Conditions

Oligometastatic Prostate Carcinoma
Prostate Adenocarcinoma

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Arizona1

Study leadership

  • Carlos E. Vargas, M.D. · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Hormonal domain scoresAt 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.