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New trial aims to cut side effects of radiation for recurrent prostate cancer

NCT ID NCT04190446

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This phase II trial tests two types of radiation therapy (proton beam or IMRT) given in fewer, larger doses for men whose prostate cancer has returned or spread to a few spots after initial treatment. The main goal is to see if this shorter course causes fewer serious side effects in the gut and urinary tract. About 84 men will take part, and the study is actively recruiting.

What this could mean

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

Active substance
radiation therapy (proton beam or intensity-modulated radiation therapy)
What this could lead to
If successful, this could offer a shorter, safer radiation option for men with recurrent prostate cancer that has spread to a few sites.
What could go wrong
This is a small, early-phase trial (84 people) focused on side effects, not on curing the cancer. It may not lead to better outcomes or be widely applicable.

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

84 people

The number who actually took part.

Started

Jan 2020

Expected to finish

Nov 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: * Male; age \>= 18 years * Histological confirmation of prostate adenocarcinoma * Recurrent prostate cancer after prior receipt of primary radiotherapy to the prostate \[can also include treatment of seminal vesicles (SVs) and lymph nodes (LNs)\] or salvage RT to the prostate fossa (can also include prior pelvic RT) * Oligometastatic extent of disease * Recurrent disease involving lymph nodes as diagnosed with choline positron emission tomography (PET)/computed tomography (CT) or other advanced PET imaging \[prostate-specific membrane antigen (PSMA) or flucyclovine\] * Limited to pelvic and/or retroperitoneal/para-aortic lymph nodes * Zubrod performance score (PS) =\< 1 * Signed informed consent Exclusion Criteria: * Bone or visceral metastases present at the time of treatment (consolidative radiotherapy allowed) * Lymph node metastases beyond the pelvis and/or retroperitoneum * Contraindications to RT (e.g., uncontrolled inflammatory bowel disease) * Contraindications to androgen suppression * Concurrent cytotoxic chemotherapy * Previous or concurrent malignancy other than non-melanoma skin cancer within 5 years of diagnosis of prostate cancer * Inability to start the radiation portion of the protocol treatment within 6 months after study enrollment * Medical or psychiatric conditions that preclude informed decision-making or compliance with the protocol treatment or follow-up

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Conditions

The condition(s) this trial relates to.

metastatic prostate carcinoma prostate adenocarcinoma prostate cancer prostate carcinoma

As listed by the trial registrant

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

Metastatic prostate adenocarcinoma Oligometastatic prostate carcinoma Prostate adenocarcinoma Recurrent prostate carcinoma Stage IV prostate cancer ajcc V8 Stage IVB prostate cancer ajcc V8

Contacts and locations

Locations

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

More trials for these conditions

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