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New radiation cocktail aims to cut prostate cancer treatment time

NCT ID NCT01655836

Disease control Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 1 trial tests a combination of two radiation techniques for men with intermediate risk prostate cancer. First, a high dose of radiation is placed inside the prostate for 10-20 minutes (brachytherapy), followed by three weeks of highly targeted external radiation (SBRT). The goal is to see if this shorter treatment plan is safe and tolerable. 42 men are enrolled.

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 (high dose rate brachytherapy and stereotactic body radiation therapy)
What this could lead to
If successful, this could lead to a shorter, more precise radiation treatment option for intermediate risk prostate cancer with fewer side effects.
What could go wrong
This is an early phase 1 trial with only 42 participants, focused on safety. It may not show better outcomes than standard treatments, and there are risks of radiation-related side effects.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

42 people

The number who actually took part.

Started

Oct 2012

Expected to finish

Jan 2040

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: * Adenocarcinoma of the prostate with intermediate risk disease T2b-T2c or Gleason score 7 or prostate specific antigen (PSA) 10-20 ng/ml, without metastatic disease * To rule out metastatic disease, patients must have the following tests: * Bone scan within 60 days prior to registration * Computed tomography (CT) of abdomen/pelvis within 60 days prior to registration * Karnofsky performance status \> 70 * Age \> 18 * PSA blood test within 60 days prior to registration * Prostate biopsy within 180 days prior to registration * Within 60 days prior to registration, hematologic minimal values: * Absolute neutrophil count \> 1,500/mm\^3 * Hemoglobin \> 8.0 g/dl * Platelet count \> 100,000/mm\^3 * Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter * No history of previous pelvic irradiation Exclusion Criteria: * History of urological surgery or procedures predisposing to GU complications after radiation, i.e., anastomoses, stricture repair, etc. (will be determined by radiation oncologist) * History of prior pelvic irradiation * Documented distant metastatic disease * Prior radical prostatectomy or cryosurgery for prostate cancer

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Conditions

The condition(s) this trial relates to.

prostate adenocarcinoma prostate cancer prostate carcinoma

As listed by the trial registrant

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

Adenocarcinoma of the prostate Prostate cancer Recurrent prostate cancer Stage IIA prostate cancer Stage IIB prostate cancer

Contacts and locations

Locations

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

More trials for these conditions

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