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New radiation boost aims to zap prostate tumors harder, faster

NCT ID NCT07325721

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 2 trial tests a new radiation approach for men with high-risk or locally advanced prostate cancer. It combines hypofractionated radiotherapy (fewer, larger doses) with a microboost that delivers extra radiation to the most aggressive tumor spots. The goal is to improve cancer control while keeping side effects manageable. About 46 men will receive 25 radiation sessions along with standard hormone therapy, and researchers will track urinary and bowel side effects, PSA levels, and quality of life for up to 5 years.

What this could mean

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

Active substance
Hypofractionated radiation therapy with a focal microboost
What this could lead to
If successful, this approach could offer a more effective and convenient radiation treatment for high-risk prostate cancer, potentially improving tumor control without increasing side effects.
What could go wrong
This is a small, early-phase trial with only 46 participants, so results may not apply to all patients. The higher radiation dose could increase urinary or bowel side effects, and long-term benefits are uncertain.

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

About 46 people

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

Started

Feb 2026

Expected to finish

Jan 2034

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. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Biologically male patients aged 18 years and older. 4. Ability to receive pelvic radiotherapy and be willing to adhere to the protocol regimen. 5. Previously untreated prostate cancer (with cytotoxic chemotherapy, cryotherapy, ablative treatment, surgical or radiation therapy). Prior transurethral resection of prostate (TURP) is permitted if 90 days or more prior to the start of radiotherapy. 6. Localized or locally advanced prostate cancer meeting NCCN criteria for high risk, very high risk or non-metastatic, pelvic lymph node positive defined as having at least one or more of the following: 1. PSA \>20 ng/mL prior to starting ADT. 2. cT3a-T4 by digital exam or imaging. 3. Gleason score of 8-10 (grade group 4 or 5). 4. Staged as N1M0 by the treating investigator (pelvic lymph node positive, below the aortic bifurcation) based on soft tissue imaging within 120 days prior to registration (may include CT, MRI or PSMA PET/CT, of fluciclovine choline PET/CT). 7. History and physical exam within 120 days prior to registration. 8. ECOG performance status 0-2. 9. Be able to undergo MRI of the prostate and/or pelvis as a component of RT planning. 10. Have at least one MRI visible target for microboost (PI-RADS≥ 4 version 2.0). 11. Bone and soft tissue imaging as clinically indicated for staging within 120 days prior to registration. 12. For males: use of condoms or other methods to ensure effective contraception with partner during radiation and for six months after completion of radiation. 13. Adequate hematologic function within 120 days prior to registration as defined by: 1. hemoglobin \>=9.0 g/dL independent of transfusion, and 2. platelet count \>= 100,000 x 10 \^9/microliter independent of transfusion. 14. Adequate hepatic function within 120 days prior to registration defined as total bilirubin \<2 x institutional upper limits of normal (ULN is 1.2 mg/dL). If labs are done at outside institution, total bilirubin should be \<2.4. 15. Agreeable and eligible to receive long term (defined as 12-36 months) ADT as a standard component of prostate cancer therapy. Exclusion Criteria: * 1\. Concurrent use of testosterone supplementation unless discontinued by time of registration. 2\. Definitive radiologic evidence of metastatic disease outside of the pelvic nodes on conventional imaging (bone scan, CT scan, MRI). 3\. Prior pelvic radiotherapy. 4. Pre-existing conditions or overall health status which disqualifies the patient from curative intent-RT. Patients with life expectancy less than 5 years are not eligible. 5\. Treatment with another investigational prostate cancer therapy within 12 months. 6\. Prior total prostatectomy, cryotherapy, high-intensity focused ultrasound, irreversible electroporation, MRI ablation, laser ablation, transurethral ultrasound ablation, aquablation directed towards the prostate for any prostate disease or condition. 7\. Prior or concurrent invasive pelvic malignancy (except non-melanomatous skin cancer) or lymphomatous or hematogenous malignancy, unless disease free for a minimum of 5 years. 8\. Any condition that, in the opinion of the investigator, would preclude participation in this study. 9\. Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both LHRH agonist and oral anti-androgen) is ≤ 90 days prior to registration. 10\. Inability to undergo implantation of gold fiducial markers or rectal spacer gel. 11\. Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Medical University of South Carolina Hollings Cancer Center

    RECRUITING

    Charleston, South Carolina, 29425, United States

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