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Could less be more? new trial tests lighter hormone therapy for prostate cancer

NCT ID NCT06369610

Disease control Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial is testing whether giving fewer hormone therapy drugs (abiraterone acetate and GnRH analogs) along with radiation can work as well as longer treatment for high-risk prostate cancer that has spread a little. The goal is to reduce side effects while still controlling the cancer. About 110 participants will receive a risk-tailored, shorter course of hormone therapy plus radiation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
abiraterone acetate (Zytiga) and gonadotropin-releasing hormone analogs
What this could lead to
If successful, this could show that a shorter, less intense hormone therapy combined with radiation is just as effective as longer treatment, with fewer side effects for high-risk prostate cancer patients.
What could go wrong
This is a phase 2 trial with only 110 participants, so results are preliminary. It may not prove that de-escalated treatment is as effective as standard care, and some patients might still need more intensive therapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

metastatic prostate carcinoma prostate adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Oligometastatic prostate carcinoma Prostate adenocarcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Mayo Clinic in Arizona

    RECRUITING

    Scottsdale, Arizona, 85259, United States

    Contact Email: •••••@•••••

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