New combo radiation aims to cut prostate cancer treatment time
NCT ID NCT06591819
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial is testing a new, shorter radiation plan for men with high-risk or unfavorable intermediate-risk prostate cancer. Participants receive a brachytherapy boost followed by just 5 sessions of whole-pelvis proton therapy. The main goal is to see if this approach is safe, with fewer than 10% of patients experiencing severe urinary or bowel side effects. The study will also track quality of life changes using surveys.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Proton therapy and brachytherapy (radiation)
- What this could lead to
- If successful, this could offer a shorter, more convenient radiation schedule for high-risk prostate cancer with fewer severe side effects.
- What could go wrong
- This is a small, early-phase trial (30 people) focused on safety, not yet proven to work better than standard treatments. There is still a risk of side effects like urinary or bowel problems.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Dec 2035
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Pathologic evidence of prostate cancer * Risk group: high or intermediate risk as defined below * High risk: T3a or Gleason Grade Group 4/5 or PSA \>20 * Unfavorable intermediate risk disease: at least one or more of the following: T2b-T2c, Gleason Grade Group 2/3, PSA 10-20, \>50% of cores positive * Must be appropriate for whole pelvis per the treating oncologist or based on lymph node predicting nomogram * Patient is a candidate for definitive external beam radiotherapy: * No prior radiotherapy in the region of study * No inflammatory bowel disease, active collagen/vascular/connective tissue disorders * Age ³18 years * ECOG performance status: 0-2 * Patients may initiate androgen deprivation therapy up to 3 months prior to radiation start, concurrently, or up to 3 months after completion of radiation therapy start. Patients may have received androgen deprivation therapy for the following months: unfavorable intermediate risk patients for 6 months; high-risk patients for 24 months. Patients will be allowed to discontinue ADT at physician and patient discretion. * Pretreatment evaluation * History \& Physical by a radiation oncologist within 6 weeks of enrollment * MRI prostate * PSMA PET * PSA level * Eligible for rectal spacer procedure as determined by treating physician * Informed consent: Patients must have the ability to understand and be willing to sign the study-specific informed consent indicating their understanding of the investigational nature and the risks of this study before any of the protocol related studies are performed (this does not include routine laboratory testing or imaging studies required to establish study eligibility); Exclusion Criteria: * Evidence of distant metastatic disease * History of inflammatory bowel or active collagen/vascular/connective tissue disorders * Prior radiation to the pelvis * Prior or concurrent second invasive malignancy other than non-melanoma skin cancers, unless disease free for minimum of five years * Known severe, active co-morbidity, defined as follows: o Any clinically significant unrelated systemic illness, medical condition, or other factor, which at the discretion of the Principal Investigators, would interfere in the safe and timely completion of study procedures, compromise the patient's ability to tolerate the protocol therapy, or is likely to interfere with the study procedures or results. * Patients should not have a prior history of TURP * Patients should not have pre-treatment IPSS \>20 or on maximum alpha-blocker medications at baseline * Patients should not be on therapeutic anticoagulation
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New PET tracer targets ACP3 to spot prostate cancer
- Can a One-Week radiation course match four weeks for prostate cancer?
- Can a new PET tracer spot hidden prostate cancer spread?
- Can a gel cushion shield the rectum during prostate radiation?
- A scanner in the operating room could show surgeons exactly where prostate cancer remains