Hormone therapy plus precision radiation aims to crush prostate cancer early

NCT ID NCT06067269

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This trial investigates whether adding the hormone therapy apalutamide to high-precision radiation (SBRT) can drive prostate-specific antigen (PSA) levels extremely low in men with intermediate-risk prostate cancer. Participants receive apalutamide to block testosterone that fuels tumor growth, along with image-guided SBRT that delivers focused radiation in fewer sessions. The goal is to see if this combination leads to better early disease control compared to historical outcomes.

What this could mean

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

Active substance
a hormone therapy called apalutamide combined with image-guided stereotactic body radiation therapy (SBRT)
What this could lead to
If successful, this combination could offer a more effective, shorter course of treatment for intermediate-risk prostate cancer, potentially improving long-term disease control.
What could go wrong
This is a phase 2 trial with a moderate number of participants, so results are not definitive. The added hormone therapy may cause side effects, and the approach may not prove better than standard treatments.

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 95 people

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

Started

Mar 2024

Expected to finish

Dec 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

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: * Confirmed diagnosis of prostate adenocarcinoma * Age ≥ 18 * Classified as having National Comprehensive Cancer Network unfavorable intermediate risk prostate cancer (i.e., \[a\] 2 of the following: PSA 10-20 ng/mL, clinical T category 2b-2c, or International Society of Urological Pathology \[ISUP\] grade group 2; \[b\] OR any 1 of \[a\] with ISUP grade group 3 disease; OR \[c\] any 1 of \[a\] with 50% or more cores on systematic biopsy showing prostate cancer) * Have a Decipher genomic classifier score * Have at least one dominant intraprostatic lesion visible on multiparametric MRI (Prostate Imaging-Reporting and Data System \[PI-RADS\] version 2.1 score 4 or 5) * Have underwent a prostate specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) * Have total testosterone \>= 150 ng/dL * Adequate performance status (Eastern Cooperative Oncology Group \[ECOG\] 0-1) * Hemoglobin ≥ 9.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomization (at screening) * Platelet count ≥ 100,000 x 10\^9/uL independent of transfusion and/or growth factors within 3 months prior to randomization (at screening) * Serum albumin ≥ 3.0 g/dL (at screening) * Glomerular filtration rate (GFR) ≥ 45 mL/min (at screening) * Serum potassium ≥ 3.5 mmol/L (at screening) * Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (Note: In subjects with Gilbert's syndrome, if total bilirubin is \> 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 x ULN, subject may be eligible) (at screening) * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 2.5 x ULN (at screening) * Medications known to lower the seizure threshold (see list under prohibited medications) must be discontinued or substituted at least 4 weeks prior to study entry Exclusion Criteria: * Any evidence of spinal cord compression (radiological or clinical) * Prior pelvic malignancy * Prior pelvic radiation * Concurrent malignancy other than adequately treated basal cell or squamous cell skin cancer, non-muscle invasive bladder cancer (NMIBC), or any other cancer in situ currently without evidence of recurrence or progression * Inability to undergo radiotherapy, or hormonal therapy * Primary small cell carcinoma of the prostate (prostate adenocarcinoma with neuroendocrine differentiation is allowed) * Inflammatory bowel disease or active collagen vascular disease * History of any of the following: * Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign central nervous system \[CNS\] or meningeal disease which may require treatment with surgery or radiation therapy) * Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization * Current evidence of any of the following: * Uncontrolled hypertension * Gastrointestinal disorder affecting absorption * Known active infection (eg, human immunodeficiency virus \[HIV\] or viral hepatitis) * Any condition that in the opinion of the investigator would preclude participation in this study * Treatment with CYP2D6 substrates that have a narrow therapeutic index. If an alternative treatment cannot be used, a dose reduction of the CYP2D6 substrate may be considered * Baseline moderate and severe hepatic impairment (Child Pugh class B \& C)

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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

  • UCLA / Jonsson Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90095, United States

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