Recruiting
Phase 2

Hormone Therapy

Sponsor:

Mayo Clinic

Code:

NCT06369610

Conditions

Oligometastatic Prostate Carcinoma

Prostate Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Abiraterone Acetate

Biospecimen Collection

Computed Tomography

Gonadotropin-releasing Hormone Analog

Magnetic Resonance Imaging

Study Details

Brief summary:

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

Oligometastatic Prostate Carcinoma

Prostate Adenocarcinoma

Study ID

NCT06369610

Start date

Apr 22, 2024

Status verified date

Nov, 2025

Completion date

Apr 22, 2027

Anticipated

Primary completion date

Apr 22, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

110 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group I (radiation therapy)

Patients undergo radiation therapy to the prostate bed over 2 - 6 weeks. Additionally, patients undergo PET, CT or MRI and blood sample collection throughout the study.

experimental: Group II (ADT, radiation therapy)

Patients receive ADT SC or IM for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy to the prostate bed over 2 - 6 weeks starting on week 8-10 of ADT hormone therapy. Additionally, patients undergo PET, CT or MRI and blood sample collection throughout the study.

experimental: Group III (ADT, radiation therapy, abiraterone acetate)

Patients receive ADT SC or IM with or without abiraterone acetate for up to 18 months in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy to identified areas over 2 - 6 weeks starting on week 8-10 of ADT hormone therapy. Additionally, patients undergo PET, CT or MRI and blood sample collection throughout the study.

Interventions

Abiraterone Acetate

Given abiraterone acetate

Biospecimen Collection

Undergo blood sample collection

Computed Tomography

Undergo CT

Gonadotropin-releasing Hormone Analog

Given SC or IM

Magnetic Resonance Imaging

Undergo MRI

Positron Emission Tomography

Undergo PET

Questionnaire Administration

Ancillary studies

Radiation Therapy

Undergo radiation therapy

Primary outcome measure

  • Hormonal domain scores [ Time Frame: At baseline and up to 2 years ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Carlos E. Vargas, M.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Nov 14, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2025-11-14.