New prostate cancer radiation cuts sessions in half
NCT ID NCT07495293
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2031
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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19 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: 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
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 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
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Other studies related to the condition(s) this trial covers.
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