Shorter, stronger radiation beams tested for prostate cancer
NCT ID NCT05705921
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 4 times
Summary
This study tests whether a shorter, more intense radiation treatment (5 sessions) is better than the standard 20-session approach for men with intermediate- or high-risk prostate cancer that hasn't spread. The goal is to improve cancer control while keeping side effects low. About 484 men will take part, and the results will be tracked for 5 years.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 484 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2023
- Expected to finish
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Jan 2032
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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Male participants only
- 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: * Men ≥ 18 years with histologically confirmed prostate adenocarcinoma * No evidence of lymph node or distant metastases N0M0. * MRI visible tumor on mpMRI (PI-RADS v2 ≥ 4). * Intermediate- or high-risk PCa, defined as at least one of the following risk criteria (note; both the clinical T-stage and imaging T stage are noted in the CRF): * clinical stage cT2c-T3a (UICC TNM 8th edition) * Imaging stage T2c, T3a or T3b with less than 5 mm invasion in the seminal vesicles (as defined on mp MRI) * ≥ Gleason score 4+3, (ISUP Grade groups 3,4 or 5) * PSA ≥ 20 ng/mL * World Health Organization (WHO) performance score ≤ 2 * International prostate symptoms score (IPSS score) \< 15 * PSA ≤ 30 ng/mL * Prostate volume ≤ 90 cc on MRI * Ability to give written informed consent and willingness to return for follow-up Exclusion Criteria: * Prior pelvic radiotherapy * TURP (transurethral prostate resection) within 6 months from start treatment * On-line image guidance based on either fiducial markers or high-quality CBCT or MRI according to local guidelines not feasible. For example: Unsafe to have gold fiducial marker implantation, if gold fiducial markers are used for image guidance. Distorted images on MR because of hip protheses prohibit accurate MR image guidance, if MR is used for image guidance. * Contraindications to MRI according to local hospital guidelines.
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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.
Contacts and locations
Locations
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Netherlands Cancer Institute
Amsterdam, 1066 CX, Netherlands
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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