Two-fraction MR-guided prostate radiation with lower dose to healthy prostate and a boost to MRI-visible tumor

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Men with low or favorable-intermediate risk prostate cancer and an MRI-visible lesion are randomly assigned to receive either a uniform high dose to the whole prostate or a de-escalated dose to MRI-normal prostate with a high-dose boost to the MRI-visible tumor, delivered in two MR-Linac sessions. Treatments are delivered using MRI guidance to precisely target the lesion and spare surrounding tissue. Participants complete urinary, bowel, and sexual health questionnaires and have regular follow-up visits with PSA monitoring for up to two years to track side effects and cancer control. The trial compares toxicity profiles and early cancer-control outcomes between the two approaches.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Netherlands Cancer Institute
  Amsterdam, Netherlands Recruiting

Study contacts

• Study coordinator: Floris Pos, MD, PhD
• Email: f.pos@nki.nl
• Phone: +31205129111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.