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Oligometastatic Prostate CarcinomaPhase 2NCT06369610

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

A Phase 2 study testing Abiraterone Acetate, Biospecimen Collection and Computed Tomography in people with Oligometastatic Prostate Carcinoma and Prostate Adenocarcinoma, run by Mayo Clinic at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Abiraterone Acetate, Biospecimen Collection and Computed Tomography
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteUnited States
Study dates
22 Apr 2024to 29 Jul 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

Other trials in United States

About this study

Official title: Risk Stratified De-Escalated De-Intensified Treatment for High Risk Prostate Cancer Patients Based on Pathologic Criteria, Genetic Score, and Biologic Imaging

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. Recovery of the Expanded Prostate Cancer Index Composite (EPIC) hormonal domain to baseline levels at 2-years.

EXPLORATORY OBJECTIVES:

  1. After completion of radiation therapy, determine the incidence of:

Ia. Grade 2 or greater genitourinary (GU) and gastrointestinal (GI) toxicity at 6 months (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0); Ib. Grade 3 or greater GU and GI toxicity at 6 months (CTCAE version 5.0); Ic. Patient-reported quality of life; Id. Impotence after the use of radiation therapy at 3 years; Ie. Freedom from biochemical failure (FFBF) at 5 years; If. Clinical failure: local and/or distant at 5 years; Ig. Salvage androgen deprivation use (SAD) at 5 years; Ih. Progression free survival: using clinical, biochemical and SAD as events at 5 years; Ij. Overall survival at 5 years; Ik. Disease-specific survival at 5 years. II. Determine overall GI and GU toxicity.

OUTLINE: Patients are assigned to 1 of 3 risk groups.

GROUP I (LOW RISK): Patients undergo radiation therapy to the prostate bed over 2 - 6 weeks.

GROUP II (INTERMEDIATE RISK): Patients receive ADT subcutaneously (SC) or intramuscularly (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.

GROUP III: (HIGH RISK): 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 positron emission tomography (PET), computed tomography (CT) or magnetic resonance imaging (MRI), and blood sample collection throughout the trial.

After completion of study treatment, patients are followed up at months 3 and 12, then yearly for up to year 5 followed by every 2 years.

Being tested
Abiraterone Acetate, Biospecimen Collection, Computed Tomography, Gonadotropin-releasing Hormone Analog, Magnetic Resonance Imaging

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abiraterone AcetateDrug

    Also called BR9004, BR9004-1, CB7630, JNJ-212082

    Given abiraterone acetate

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • Gonadotropin-releasing Hormone AnalogBiological

    Also called GnRH Agonist, GnRH Analog, Gonadotropin-Releasing Hormone Agonist, Gonadotropin-Releasing Hormone Analogue

    Given SC or IM

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET

  • Questionnaire AdministrationOther

    Ancillary studies

  • Radiation TherapyRadiation

    Also called Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate

    Undergo radiation therapy

Study groups in NCT06369610
Study groupRoleWhat they receive
Group I (radiation therapy)ExperimentalPatients 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.
Receives: 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)ExperimentalPatients 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.
Receives: 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)ExperimentalPatients 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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At baseline and up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2024
  2. Study start22 Apr 2024
  3. Primary completion29 Jul 2028 (estimated)
  4. Study completion29 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06369610
Sponsor's protocol ID
GMROA2256
Other IDs
NCI-2024-03020, 22-012591, GMROA2256
Status last verified
Sep 2026
First submitted
12 Apr 2024
Last updated
25 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abiraterone Acetate, Biospecimen Collection and Computed Tomography in people with Oligometastatic Prostate Carcinoma and Prostate Adenocarcinoma, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hormonal domain scores (time frame: At baseline and up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06369610.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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