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New prostate cancer radiation cuts sessions in half

NCT ID NCT07495293

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-phase study tests a shorter, more intense form of carbon-ion radiation for men with low- or intermediate-risk prostate cancer. Instead of the usual 12 sessions, patients receive just 6. The main goal is to check safety and side effects within 90 days. Up to 20 men will take part, and some may also receive hormone therapy for 6 months.

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 20 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Mar 2031

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

19 years and older

Sex

Anyone

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. Male patients aged 19 years or older who are able to provide written informed consent 2. Histologically confirmed prostatic adenocarcinoma within 6 months prior to the first treatment (either carbon ion radiotherapy or androgen deprivation therapy, whichever comes first) 3. Documented pre-biopsy serum prostate-specific antigen (PSA) level available 4. Classified as one of the following risk groups based on NCCN Guidelines Version 5.2026: * Low risk: PSA ≤10 ng/mL AND Gleason score 6 (Grade Group 1) AND cT1-T2a * Intermediate risk: PSA 10-20 ng/mL OR Gleason score 7 (Grade Group 2-3) OR cT2b-T2c, without any high-risk features 5. No evidence of distant metastasis or regional lymph node metastasis 6. Adequate general condition for prostate cancer treatment as determined by ECOG Performance Status 0 or 1 7. Multiparametric prostate MRI performed prior to biopsy Exclusion Criteria: 1. Prior history of pelvic radiotherapy or prostate surgery 2. History of malignancy other than prostate cancer, except for the following: cervical carcinoma in situ, completely resected non-melanoma skin cancer, or any cancer with disease-free status maintained for 5 or more years after treatment 3. Patients deemed inappropriate for carbon ion radiotherapy due to active infection, bleeding disorders, or severe cardiac, hepatic, or renal dysfunction, or patients who have undergone major surgery or experienced a major cardiovascular event (e.g., myocardial infarction, cerebral infarction, or cerebral hemorrhage) within the past 6 months 4. Patients with evidence of prostatitis or urinary tract infection on screening urinalysis and urine culture (However, enrollment is permitted if the condition improves on follow-up evaluation prior to carbon ion radiotherapy.) 5. Patients with psychiatric disorders or cognitive impairment considered unable to comply with the treatment plan 6. Patients currently participating in another investigational drug or medical device study concurrently with this study 7. Patients for whom carbon ion radiotherapy is physically difficult due to artificial hip prostheses or other metallic implants 8. Patients who underwent multiparametric prostate MRI after biopsy 9. Patients with a history of surgical treatment for benign prostatic hyperplasia, such as transurethral resection of the prostate (TURP) or holmium laser enucleation of the prostate (HoLEP)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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  1. The official record

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