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Radioactive seeds take aim at prostate cancer without extra hormones

NCT ID NCT00525720

Disease control Sponsor: M.D. Anderson 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Updated 3 times

Summary

This study tests whether a one-time procedure called brachytherapy, where tiny radioactive seeds are placed directly into the prostate, can control intermediate risk prostate cancer without needing additional treatments. Three hundred men with specific tumor features (Gleason score and PSA levels) are taking part. The main goal is to see how long the cancer stays under control, measured by PSA levels.

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

300 people

The number who actually took part.

Started

Aug 2006

Expected to finish

Sep 2030

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: 1. Histologically confirmed adenocarcinoma of the prostate, clinical stage T1c - T2b (AJCC 6th Edition), N0, M0. Lymph node evaluation by either CT or MRI. 2. Zubrod performance status 0-1. 3. Patient must be greater than or equal to 18 years of age. 4. Patients with intermediate risk prostate cancer as determined by one of the following combinations: Gleason \< 7, PSA 10-15; Gleason 7, PSA must be \< 10. 5. Prostate specific antigen (PSA) prior to study entry must be less than or equal to 15 ng/ml. 6. Hormone naive. 7. Prostate volumes by TRUS less than or equal to 60 cc. 8. AUA voiding symptom scores \</= 15 (alpha blockers allowed); this is completed by the patient. 9. Patients must sign a study-specific informed consent form prior to study entry. Exclusion Criteria: 1. Stage \< T1c, T2c, T3 or T4 disease (AJCC 6th Edition). 2. Lymph node involvement (N1). 3. Evidence of distant metastases (M1). 4. Radical surgery for carcinoma of the prostate, prior pelvic radiation, prior chemotherapy for prostate cancer, prior TURP, prior cryosurgery, TUNA, TUMT of the prostate. 5. Active prostatitis.

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Conditions

The condition(s) this trial relates to.

prostate cancer prostate carcinoma

As listed by the trial registrant

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

Prostate cancer

Contacts and locations

Locations

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

More trials for these conditions

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