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Prostate cancer radiation cut to just 5 sessions in new trial

NCT ID NCT00911118

Disease control Sponsor: Memorial Sloan Kettering 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase I trial tested a new type of radiation therapy for low- and intermediate-risk prostate cancer that delivers a higher dose each day, completing treatment in just 5 sessions over 2 weeks instead of the usual 45-48. The study enrolled 120 participants to check the safety and side effects of this approach. Researchers also looked at PSA levels, biopsy results, and sexual function after treatment.

What this could mean

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

Active substance
ultra-hypofractionated image-guided intensity-modulated radiotherapy
What this could lead to
If successful, this could offer a shorter, more convenient radiation treatment for prostate cancer, reducing the number of sessions from 45-48 to just 5 over 2 weeks.
What could go wrong
This is an early phase I trial focused on safety, so it's not yet proven to be effective. The higher daily radiation dose may increase side effects, and results may not apply to all prostate cancer patients.

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

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2009

Finished

May 2026

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 85 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: Eligibility is not restricted to MSKCC to confirm biopsy/diagnosis. Participating institution testing is sufficient. * Low and intermediate risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per NCCN guidelines. * Low risk patients will be defined as: * PSA \< or = to 10 ng/ml and * Gleason score = 6 and * Clinical Stage \< or = to T2a * Intermediate risk patients will be defined as: * PSA 10-20 ng/ml or * Gleason score = 7 or * Clinical stage T2b/T2c Additionally, patients will be required to meet the following criteria: * Age \> or = to 18 * KPS \> or = to 70 * Pre-treatment endorectal coil MRI or CT (MRI preferred) at MSKCC showing no definite evidence of radiographic T3, T4, or N1 disease * Prostate size \< or = to 60 cc * International Prostate Symptom Score \< or = to 15 Exclusion Criteria: * Prior androgen deprivation therapy for prostate cancer * Elective pelvic lymph node irradiation * KPS \< 70 * Pelvic MRI or CT (MRI preferred) evidence of radiographic T3, T4 or N1 disease * Presence of distant metastasis as determined by: o alkaline phosphatase \> or = to ULN or * whole body bone scan positive for osseous metastases * Prior history of transurethral resection of the prostate * Prior history of chronic prostatitis * Prior history of urethral stricture * Prior history of pelvic irradiation * History of inflammatory bowel disease * Unable to give informed consent * Unable to complete quality of life questionnaires Abnormal complete blood count. Any of the following * Platelet count less than 75,000/ml * Hb level less than 10 gm/dl * WBC less than 3.5/ml * Abnormal renal function tests (creatinine \> 1.5)

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Conditions

The condition(s) this trial relates to.

adenocarcinoma prostate cancer

As listed by the trial registrant

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

Adenocarcinoma Prostate cancer

Contacts and locations

Locations

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Cancer Center @ Suffolk

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Cancer Center@Phelps

    Sleepy Hollow, New York, United States

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering West Harrison

    Harrison, New York, 10604, United States

  • Memorial Sloan Kettering at Mercy Medical Center

    Rockville Centre, New York, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

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