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

NCT06369610 | Recruiting Phase 2

• 3 other identifiers: GMROA2256NCI-2024-0302022-012591
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Hormonal domain scores

  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.

  At baseline and up to 2 years

Study Arms (3)

Group I (radiation therapy)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Radiation: Radiation Therapy

Group II (ADT, radiation therapy)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Procedure: Computed Tomography; Biological: Gonadotropin-releasing Hormone Analog; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Radiation: Radiation Therapy

Group III (ADT, radiation therapy, abiraterone acetate)

EXPERIMENTAL

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.

Drug: Abiraterone Acetate; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Biological: Gonadotropin-releasing Hormone Analog; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Radiation: Radiation Therapy

Interventions

Abiraterone Acetate DRUG

Given abiraterone acetate

Also known as: BR9004, BR9004-1, CB7630, JNJ-212082, Yonsa, Zytiga

Group III (ADT, radiation therapy, abiraterone acetate)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Group I (radiation therapy); Group II (ADT, radiation therapy); Group III (ADT, radiation therapy, abiraterone acetate)

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

Group I (radiation therapy); Group II (ADT, radiation therapy); Group III (ADT, radiation therapy, abiraterone acetate)

Gonadotropin-releasing Hormone Analog BIOLOGICAL

Given SC or IM

Also known as: GnRH Agonist, GnRH Analog, Gonadotropin-Releasing Hormone Agonist, Gonadotropin-Releasing Hormone Analogue, LH-RH agonist, LH-RH Analogs, LHRH Agonist, luteinizing hormone-releasing hormone agonist, Luteinizing Hormone-Releasing Hormone Analog

Group II (ADT, radiation therapy); Group III (ADT, radiation therapy, abiraterone acetate)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Group I (radiation therapy); Group II (ADT, radiation therapy); Group III (ADT, radiation therapy, abiraterone acetate)

Positron Emission Tomography PROCEDURE

Undergo PET

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

Group I (radiation therapy); Group II (ADT, radiation therapy); Group III (ADT, radiation therapy, abiraterone acetate)

Questionnaire Administration OTHER

Ancillary studies

Group I (radiation therapy); Group II (ADT, radiation therapy); Group III (ADT, radiation therapy, abiraterone acetate)

Radiation Therapy RADIATION

Undergo radiation therapy

Also known as: Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation

Group I (radiation therapy); Group II (ADT, radiation therapy); Group III (ADT, radiation therapy, abiraterone acetate)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Abiraterone Acetate; Specimen Handling; Gonadotropin-Releasing Hormone; Magnetic Resonance Spectroscopy; Radiotherapy; Radiation

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Spectrum Analysis; Chemistry Techniques, Analytical; Therapeutics; Physical Phenomena

Study Officials

• Carlos E. Vargas, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 17, 2024
• Study Start: April 22, 2024
• Primary Completion (Estimated): April 22, 2027
• Study Completion (Estimated): April 22, 2027
• Last Updated: November 14, 2025

Record last verified: 2025-11

Locations

US (1)