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Shorter, stronger radiation for prostate cancer: a new hope?

NCT ID NCT04147806

Disease control Sponsor: Albert Einstein College of Medicine 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tests two ultra-high-dose radiation schedules in 31 men with intermediate-risk prostate cancer. One group gets five high-dose sessions over a week; the other gets a single massive dose. The goal is to see if these shorter treatments are safe and can control the cancer. Participants are followed for at least 5 years to monitor side effects and tumor response.

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 (IGRT) with dexamethasone and tamsulosin
What this could lead to
If successful, this could lead to a shorter, more convenient radiation treatment for prostate cancer with fewer side effects.
What could go wrong
This is a very early Phase 1 pilot study with only 31 participants. The high radiation dose may cause unexpected urinary, rectal, or sexual side effects. Results may not apply to all 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

31 people

The number who actually took part.

Started

Aug 2016

Expected to finish

Jul 2026

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

50 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: * Signed study specific informed consent form; * Histologic confirmation of adenocarcinoma of the prostate by biopsy; * PSA ≤ 20 ng/mL; * Gleason score 7; * Staging MRI must confirm American Joint Committee on Cancer (AJCC) stage T1, T2a, T2b or T2c; * No direct evidence of regional or distant metastases after appropriate staging studies; * Age ≥ 50; * Performance Status 0-2; * Internation Prostate Symptom Score score must be ≤ 15 (alpha blockers allowed); * CT scan or Ultrasound-based volume estimation of prostate gland ≤ 100 grams; Exclusion Criteria: * Positive lymph-nodes or metastatic disease from prostate cancer on imaging studies * Prior invasive malignancy unless disease-free for a minimum of 5 years * Tumour Clinical stage T3 or T4 on MRI * PSA \> 20 ng/mL * Gleason score \> 7 * Previous pelvic radiotherapy * Previous surgery for prostate cancer * Previous transurethral resection of the prostate (TURP) * History of Crohn's Disease or Ulcerative Colitis * Previous significant urinary obstructive symptoms * Significant psychiatric illness * Ultrasound or CT estimate of prostate volume \> 100 grams * Severe, active co-morbidity

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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

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467-2490, United States

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