Can a shorter hormone therapy course be just as effective for High-Risk prostate cancer?

NCT ID NCT07777263

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This phase III trial is investigating whether a shorter course of hormone therapy (12 months) is as effective as the standard longer course (24 months) for certain men with high-risk prostate cancer. The study uses imaging and tumor tests to identify patients who might benefit from less treatment, aiming to reduce side effects without compromising cancer control. Participants will receive radiation therapy plus either the shorter or longer hormone therapy, and the trial will compare outcomes like cancer recurrence and survival.

What this could mean

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

Active substance
Zoladex (goserelin), a hormone therapy that lowers testosterone
What this could lead to
If successful, this could identify patients who can safely receive a shorter course of hormone therapy, reducing side effects while maintaining cancer control.
What could go wrong
The trial is still testing this approach, and it may not work for all patients. Shorter treatment could potentially increase the risk of cancer recurrence in some individuals.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 600 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2040

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

Male participants only

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: * • Able to understand and sign informed consent form (ICF); * Males aged ≥ 18 years; * Histologically confirmed adenocarcinoma of the prostate; * Participants with high-risk prostate cancer according to either of the following: a) High-risk disease - at least one of the following: i. T3a ii. Gleason 8 or less iii. PSA ≤ 30 ng/mL iv. Gleason 9 (4+5) not more than 30% of the biopsy (e.g. a 10-needle biopsy can only have a maximum of 3 x 9 \[4+5\]); * PTEN-proficient tumor confirmed by CLIA-certified immunohistochemistry (IHC); * PSMA-PET within 90 days prior to randomization: negative for nodal or distant disease. * Candidate for definitive radiation to prostate and pelvis; * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 or Karnofsky performance status of ≥70%; * Testosterone ≥150 ng/dL or 5 nmol/L; * Adequate hematologic, renal, liver function (Hemoglobin ≥10 g/dL, Absolute Neutrophil Count ≥1.5x10⁹/L, Platelets ≥100x10⁹/L); * Judged to be medically fit for ADT and RT; * Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up. * Sexually active patients, unless surgically sterile, must agree to use condoms as an effective barrier method and refrain from sperm donation during the study treatment and for 3 months after the end of the study treatment. Exclusion Criteria: * • Prior local or systemic therapy for prostate cancer (e.g. ADT, chemotherapy or novel Androgen Receptor Inhibitors \[ARIs\]); * PSMA-PET positive nodal or distant metastases; * PTEN loss or equivocal by IHC (at least more than 50%); * Evidence of nodal or distant metastases on conventional imaging; * Prior pelvic radiation or prostate surgery interfering with RT (except biopsy/TURP); * Life expectancy \<5 years regardless of the prostate cancer; * Severe concurrent disease, infection, or co-morbidity that would make the patient inappropriate for enrollment (e.g. cardiovascular disease, hypertension, diabetes, etc); * Uncontrolled cardiovascular disease including: * Myocardial infarction within 6 months; * Unstable angina; * Congestive Heart Failure: New York Heart Association (NYHA) class III or IV; * Severe arrhythmia; * Active severe infection or immunocompromised; * Active second malignancy within 5 years with the exception of: * Non-melanoma skin cancer; * Chronic Lymphocytic Leukemia (CLL) that is stable and not actively treated; * Any condition compromising adherence to the protocol.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for High-risk prostate cancer are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

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

  2. 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 ↗

  3. 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

Locations

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.