A Pilot Study of Dose dE-eScalaTion IN prostATe radIOtherapy usiNg the MRL

Not Applicable

Active, not recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT06284304
• Lead Sponsor: The Netherlands Cancer Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-2-5
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Men aged =18 years<br><br> 2. Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy<br><br> 3. Gleason score 3+3, 3+4 or 4+3 (Grade groups 1, 2 or 3)<br><br> 4. MRI stage T2 or less (as staged by AJCC TNM 2018)<br><br> 5. MRI-visible tumour(s) of PIRADS v2 grade 3 or higher on T2 and diffusion-weighted<br> imaging and/or dynamic contrast-enhanced imaging with concordant pathology<br><br> 6. Dominant lesion <50% of prostate on any axial slice and <50% total prostate<br> volume<br><br> 7. PSA <20 ng/ml prior to starting ADT<br><br> 8. Patients can be concurrently treated with androgen deprivation therapy if this would<br> be standard of care. LHRH analogues or Bicalutamide are permitted. ADT is not<br> mandatory where this would usually be omitted.<br><br> 9. WHO Performance status 0-2<br><br> 10. Ability of the participant understand and the willingness to sign a written informed<br> consent form.<br><br> 11. Ability/willingness to comply with the patient reported outcome questionnaires<br> schedule throughout the study.<br><br>Exclusion Criteria:<br><br> 1. Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant,<br> claustrophobia)<br><br> 2. IPSS 19 or higher<br><br> 3. High grade disease (GG3) occult to MRI-defined lesion<br><br> 4. Post-void residual >100 mls, where known<br><br> 5. Prostate volume >90cc<br><br> 6. Comorbidities which predispose to significant toxicity (e.g. inflammatory bowel<br> disease) or preclude long term follow up<br><br> 7. Unilateral or bilateral total hip replacement, or other pelvic metalwork which<br> causes artefact on diffusion-weighted imaging<br><br> 8. Previous pelvic radiotherapy<br><br> 9. Patients needing >6 months of ADT due to disease parameters.<br><br> 10. Previous invasive malignancy within the last 2 years excluding basal or squamous<br> cell carcinomas of the skin, low risk non-muscle invasive bladder cancer (assuming<br> cystoscopic follow up now negative) or small renal masses on surveillance

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Technical feasibility of treating prostate cancer with toxicity minimising radiotherapy on a MR-linac

Secondary Outcome Measures

Name	Time	Method
Acute GU toxicity;Acute GI toxicity;Late GU toxicity;Late GI toxicity;PROMs;Biochemical free survival