Reducing radiation doses in prostate cancer treatment using advanced technology

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

This feasibility study aims to evaluate the technical feasibility of dose de-escalation in radiotherapy for men with intermediate risk prostate cancer using a Magnetic Resonance Linear Accelerator (MR-linac). Participants will receive targeted radiotherapy with a total dose of 30Gy to the whole prostate and 45Gy to the dominant lesion, delivered in 5 fractions. The study will assess gastrointestinal and genitourinary toxicity as well as Prostate-Specific Antigen (PSA) control for up to 2 years post-treatment. A total of 20 men will be recruited, and the primary endpoint will be evaluated after 14 patients complete their treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Men aged ≥18 years
* Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy
* Gleason score 3+3, 3+4 or 4+3 (Grade groups 1, 2 or 3)
* MRI stage T2 or less (as staged by AJCC TNM 2018)
* MRI-visible tumour(s) of Prostate Imaging-Reporting and Data System (PIRADS) v2 grade 3 or higher on T2 and diffusion-weighted imaging and/or dynamic contrast-enhanced imaging with concordant pathology
* Tumour nodule visible on MRI occupying \<50% of prostate on any axial slice and \<50% total prostate volume
* PSA \<20 ng/ml prior to starting androgen deprivation therapy (ADT)
* Patients can be concurrently treated with androgen deprivation therapy if this would be standard of care. Luteinizing hormone-releasing hormone (LHRH) analogues or Bicalutamide are permitted. ADT is not mandatory where this would usually be omitted.
* World Health Organisation (WHO) Performance status 0-2
* Ability of the participant understand and the willingness to sign a written informed consent form.
* Ability/willingness to comply with the patient reported outcome questionnaires schedule throughout the study.

Exclusion Criteria:

* Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia)
* IPSS 19 or higher
* High grade disease (GG3) occult to MRI-defined lesion
* Post-void residual \>100 mls, where known
* Prostate volume \>90cc
* Comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up
* Unilateral or bilateral total hip replacement, or other pelvic metalwork which causes artefact on diffusion-weighted imaging
* Previous pelvic radiotherapy
* Patients needing \>6 months of ADT due to disease parameters.
* Previous invasive malignancy within the last 2 years excluding basal or squamous cell carcinomas of the skin, low risk non-muscle invasive bladder

Where it's running

• The Royal Marsden Hospital
  Sutton, Surrey, United Kingdom Recruiting

Study contacts

• Study coordinator: Alison Tree, MBBS
• Email: alison.tree@icr.ac.uk
• Phone: 02086613269

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Lower-dose radiation to parts of the prostate for some men with prostate cancer

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• Focal HDR-Brachytherapy for Prostate Cancer

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• Shorter androgen deprivation in combination with radiation for high-risk prostate cancer

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• PSMA PET/CT plus MRI to find higher‑grade prostate cancer in men on active surveillance

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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.