NCT07391982 Dose De-escalation in Prostate Radiotherapy Using an MR-Linac in Two Fractions
| NCT ID | NCT07391982 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Netherlands Cancer Institute |
| Condition | Prostate Cancer (Adenocarcinoma) |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2025-11-17 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 54 participants in total. It began in 2025-11-17 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to find out whether lowering the radiation dose to parts of the prostate without visible tumor on MRI can reduce side effects while still effectively treating prostate cancer in men with low or intermediate-risk prostate cancer. The main questions it aims to answer are: * Does reducing the radiation dose to healthy prostate tissue lower the risk of bowel and urinary side effects? * Can we maintain good cancer control by keeping a high dose for MRI-visible tumor areas? Researchers will compare two treatment approaches: * One group receives a uniform high dose to the entire prostate. * The other group receives a lower dose to healthy prostate tissue and a high dose only to visible tumor areas. Participants will: * Receive two sessions of MRI-guided radiotherapy using an MR-Linac. * Complete questionnaires about urinary, bowel, and sexual health before and after treatment. * Have follow-up visits to monitor side effects and PSA levels for up to 2 years.
Eligibility Criteria
Inclusion Criteria: 1. Men aged ≥18 years 2. Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy 3. Gleason score 3+3, 3+4 or 4+3 (ISUP Grade groups (GG) 1, 2 or 3) 4. MRI-visible tumour(s) of PIRADS v2 grade 3 or higher and able to be delineated on T2 and diffusion-weighted imaging +/- dynamic contrast-enhanced imaging. Tumour nodule visible on MRI should be considered able to be boosted by treating clinician and \<2.5cm in maximal dimension. MRI must be performed within 3 months of trial entry 5. The MRI-defined lesion must be confirmed as malignant on biopsies (any Gleason grade is sufficient as long as Gleason score is reported). 6. MRI stages mT1 and T2 or mT3a with ≤ 1mm tumour outside gland AND otherwise favourable intermediate risk characteristics (Gleason 3+3, 3+4)(as staged by AJCC TNM 2018) 7. PSA \<20 ng/ml prior to starting androgen deprivation therapy (ADT). 8. WHO Performance status 0-2 9. Ability of the participant to understand and the willingness to sign a written informed consent (IC) form. 10. Ability/willingness to comply with the patient reported outcome questionnaires schedule throughout the study. Exclusion Criteria: 1. Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia) 2. IPSS Score \> 19 3. High grade disease (GG3) occult to MRI-defined lesion. As a guide, any pathology for which you would consider surveillance is allowed outside of the MRI-defined area. 4. Prostate volume \>90cc 5. Comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up 6. Hip replacement, or other pelvic metalwork which causes artefact on diffusion-weighted imaging 7. Previous pelvic radiotherapy 8. Patients needing \>6 months of ADT due to disease parameters. 9. Previous invasive malignancy within the last 2 years excluding basal or squamous cell carcinomas of the skin, low risk non-muscle invasive bladder cancer (assuming cystoscopic follow up now negative) or small renal masses on surveillance.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07391982 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer (Adenocarcinoma). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07391982 currently recruiting?
Yes, NCT07391982 is actively recruiting participants. Contact the research team at f.pos@nki.nl for enrollment information.
Where is the NCT07391982 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT07391982 clinical trial?
NCT07391982 is sponsored by The Netherlands Cancer Institute. The trial plans to enroll 54 participants.
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