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New combo treatment targets returned prostate cancer

NCT ID NCT03553602

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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 study tested a treatment for prostate cancer that came back after previous radiation. It combined temporary radioactive implants placed in the prostate, daily external radiation to the pelvis for 5 weeks, and 6 months of hormone therapy. The goal was to see if this approach could control the cancer and what side effects might occur. Only 3 people took part before the study was stopped early.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

3 people

The number who actually took part.

Started

Dec 2017

Finished

Jul 2024

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 to 99 years

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 * Biopsy proven locally recurrent adenocarcinoma of the prostate after the completion of definitive radiation therapy for initially diagnosed prostate cancer. * Initial cancer diagnosis that fits these specific criteria: * Stages cT1-T3a * Nx or N0 * Mx or M0 * Eligible initial definitive radiotherapy modalities include: * External beam radiotherapy, with photon or proton beam therapy * Definitive Brachytherapy * Stereotactic Body Radiotherapy * Fluciclovine-positive pelvic nodes (as determined by an interpreting radiologist or nuclear medicine physician) in the pelvic nodal region (defined as the pelvic nodal regions up to the common iliac nodal region) without any evidence of lymph node involvement outside of this area or distant metastases * Candidate for hormonal therapy. * Current ECOG Performance status Scale 0-2 (Appendix D) * Current International Prostate Symptom Score (IPSS) \< 20 (Appendix B) * Age \>18 * The patient must be medically suitable to receive general or spinal anesthesia. * AST, ALT, and alkaline phosphatase \< 2 x upper institutional limit within 3 months of registration. * The patient must be able and willing to sign a study-specific written informed consent form before study entry. Exclusion Criteria * Preregistration radiation-related GI or GU toxicity (for any reason) grade ≥ 3 as defined in CTCAE version 4.03. That is, grade ≥ 3 GU or GI toxicity after first course of radiotherapy * Treatment to a "whole pelvis" field with initial radiotherapy * Patients with distant metastases (such as to the bone, visceral organs, and lymph nodes other than the pelvic nodes including the common iliac nodes). * Patients receiving any other investigational agents. * Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, severely symptomatic congestive heart failure, cardiac arrhythmia, recent myocardial infarction in last 6 months, or psychiatric illness/social situations that could limit compliance with study requirements. * Patients who have received chemotherapy or immunotherapy within one month prior to study enrollment, other than ADT.

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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.

Contacts and locations

Locations

  • Loyola University Medical Center

    Maywood, Illinois, 60153, United States

More trials for these conditions

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