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New radiation approach may offer shorter, safer treatment for recurrent prostate cancer

NCT ID NCT06205316

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Updated 4 times

Summary

This study tests whether a precise, short-course radiation method (SBRT) works as well as a slightly longer radiation approach (hypofractionated radiotherapy) for men whose prostate cancer has come back or spread to a few spots after surgery. About 118 participants will receive one of the two treatments. The goal is to see if SBRT causes fewer serious side effects while still controlling the cancer.

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

118 people

The number who actually took part.

Started

Apr 2024

Expected to finish

Sep 2028

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: * Histologically confirmed prostate adenocarcinoma at the time of surgery * Pathologic stages T2-T3b, Nx or N0-1, M0-1 as staged by the pathology report (American Joint Committee on Cancer \[AJCC\] Criteria 8th edition \[Ed.\]) * PSA post radical prostatectomy ≥ 0.1 and \< 2.0 ng/mL ≤ 90 days prior to enrollment, obtained ≥ 6 weeks after surgery * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 assessed ≤ 90 days of enrollment * Patients must sign institutional review board (IRB) approved study specific informed consent * Patients must complete all required pre-entry tests within the specified time frames * Patients must be able to start treatment (ADT or radiation) ≤ 120 days of study registration * Patients must be ≥ 18 years old * Prostate cancer up to oligometastatic disease, up to 5 sites Exclusion Criteria: * Previous pelvic radiation * Prior androgen deprivation therapy for prostate cancer and PSA ≥ 0.1 ng/mL * 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 * 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) * History of myocardial infarction or decompensated congestive heart failure (CHF) within the last 6 months * On a transplant list * More than oligometastatic disease \> 5 metastatic sites

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Conditions

The condition(s) this trial relates to.

metastatic prostate carcinoma prostate adenocarcinoma prostate cancer

As listed by the trial registrant

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

Biochemically recurrent prostate carcinoma Oligometastatic prostate carcinoma Recurrent prostate adenocarcinoma Stage IIB prostate cancer ajcc V8 Stage IIC prostate cancer ajcc V8 Stage III prostate cancer ajcc V8 Stage IV prostate cancer ajcc V8

Contacts and locations

Locations

  • Mayo Clinic Health System - Mankato

    Mankato, Minnesota, 56001, United States

  • Mayo Clinic Health System in Albert Lea

    Albert Lea, Minnesota, 56007, United States

  • Mayo Clinic Health System-Eau Claire Clinic

    Eau Claire, Wisconsin, 54701, United States

  • Mayo Clinic Health System-Franciscan Healthcare

    La Crosse, Wisconsin, 54601, United States

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

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