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New combo therapy for prostate cancer shows promise in early trial

NCT ID NCT01517451

Disease control Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 completed Phase 1/2 trial tested a combination of stereotactic body radiation therapy (5 high-dose sessions) and 4 months of hormone therapy in 45 men with intermediate-risk prostate cancer. The goal was to see how well this approach controls cancer and what side effects occur. Results help guide future treatment options.

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 and hormone therapy (androgen deprivation therapy)
What this could lead to
If successful, this combination could offer a shorter, more convenient treatment option that controls prostate cancer for years with manageable side effects.
What could go wrong
This is an early-phase trial with only 45 participants, so results may not apply to all patients. There is a risk of urinary or bowel side effects from the radiation.

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

45 people

The number who actually took part.

Started

May 2013

Finished

Dec 2025

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 100 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: * Histologically confirmed, locally confined adenocarcinoma of the prostate * Patient must fit D'Amico intermediate risk criteria by clinical stage (T2b-T2c), PSA (prostatic specific antigen) (10-20 ng/mL), and/or Gleason score (Gleason 7). * The patient has decided to undergo external beam radiation as treatment choice for his prostate cancer. * Signed study-specific consent form prior to registration Exclusion Criteria: * Stage T3-4 disease. * Gleason 8 or higher score. * PSA \> 20 ng/ml. * IPSS (International Prostate Symptom Score) \> 15 * Clinical or Pathological Lymph node involvement (N1). * Evidence of distant metastases (M1). * Radical surgery for carcinoma of the prostate. * Previous Chemotherapy, unless intervention was greater than 5 years from beginning treatment for current prostate cancer. * Previous pelvic radiation therapy. * Previous or concurrent cancers other than basal or squamous cell skin cancers or superficial bladder cancer unless disease free for at least 5 years. * History of inflammatory bowel disease. * Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow up. * Myocardial infarction or cerebrovascular accident within one year from consultation, or other major vascular risk factor which would prevent a patient from receiving appropriate androgen deprivation therapy.11 * Liver function tests (LFTs) greater than twice the upper limit of normal.

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Conditions

The condition(s) this trial relates to.

prostate adenocarcinoma

As listed by the trial registrant

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

Adenocarcinoma of the prostate

Contacts and locations

Locations

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016, United States

  • Suburban Hospital

    Bethesda, Maryland, 20814, United States

  • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231, United States

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