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New study: could targeted radiation alone beat prostate cancer without hormone pills?

NCT ID NCT05169970

Disease control Sponsor: Memorial Sloan Kettering Cancer Center Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 15, 2026 · Updated 2 times

Summary

This study tests whether a precise type of radiation (SBRT) alone can control unfavorable intermediate-risk prostate cancer, avoiding the need for hormone therapy. About 215 participants will receive SBRT, with the radiation dose guided by a genetic test (Decipher) to personalize treatment. The goal is to see if this approach prevents cancer from returning or spreading.

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

222 people

The number who actually took part.

Started

Dec 2021

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: * Pathologically proven diagnosis of prostate adenocarcinoma within 12 months of enrollment * Unfavorable intermediate risk prostate cancer by NCCN 2021 risk stratification guidelines, including any of the following clinicopathologic features: * Gleason Score 4+3 * ≥ 50% biopsy cores positive * Two or more of the following risk factors: * Grade Group 2 or 3 * cT2b-T2c * PSA 10 - 20 ng/mL * Able to undergo MRI for initial staging and MR based radiation planning * Sufficient biopsy tissue available for Decipher genomic testing * Prostate volume \< 90cc * IPSS ≤ 20 * Age ≥ 18 * KPS ≥ or ECOG 0-2 * Estimated life expectancy \>5 years * Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization) Exclusion Criteria: * Radiographic T3-T4 detected on staging mpMRI °Must be "consistent with" (\>90% probability) or suspicious for/probable/probably (75%-90% probability) ofT3-T4 disease determined by the reading radiologist. * Evidence of distant metastases as determined by MRI, PET, or CT imaging * Evidence of pelvic lymph node involvement as determined by MRI, PET, or CT imaging * Prior treatment for prostate cancer including chemotherapy, surgery, or hormonal therapy * Prior pelvic radiation * Active second malignancy or past history of malignancies diagnosed within the last 2 years that requires active therapy and/or in remission, with the exception of resected non-melanoma skin cancers, non-muscle invasive bladder cancer, stage I head and neck cancer, or stage I colorectal cancer * TURP or greenlight PVP within 6 months of enrollment * History of Crohn's Disease or Ulcerative Colitis

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Conditions

The condition(s) this trial relates to.

prostate cancer

As listed by the trial registrant

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

Prostate cancer

Contacts and locations

Locations

  • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen (All Protocol Activities)

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Monmouth (All Protocol Activities)

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau (All Protocol Activities)

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Westchester (All Protocol Activities)

    Harrison, New York, 10604, United States

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