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

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

NCT ID: NCT06284304

Condition: Prostate Cancer

Conditions: Official terms:
Prostatic Neoplasms

Conditions: Keywords:
Radiotherapy
De-escalation
Prostate cancer
MR-Linac

Study type: Interventional

Study phase: N/A

Overall status: Active, not recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: De-escalated radiotherapy
Description: 5 fraction de-escalated dose SBRT protocol
Arm group label: Experimental radiotherapy treatment

Summary: Trial design: A single centre phase II non-randomised study Trial population: Men with intermediate risk localised prostate cancer Recruitment target: 20 patients in total Trial objectives: - Primary To develop a 5 fraction de-escalated dose SBRT protocol capable of reducing side effects - Secondary - To assess levels of acute GU and GI toxicity (CTCAE) - To assess levels of late GU and GI toxicity (CTCAE) - To assess late sexual quality of life (expanded EPIC, IIEF-5) - To assess biochemical relapse-free survival at 2 years Trial treatment: All radiotherapy will be delivered on the MR-linac. Intraprostatic dose will be varied according to risk of local recurrence, based on mpMRI, PSA and histology. The whole prostate will receive 30 Gy in 5 fractions and the GTV plus intra-prostatic margin will receive an isotoxic 45 Gy prescription.

Detailed description: Primary endpoint: Technical feasibility of treating prostate cancer with toxicity- minimising radiotherapy on an MR-linac Secondary endpoint: - Physician reported GU and gastrointestinal (GI) toxicity (CTCAE grade) at baseline and the end of treatment then at 4 weeks and 3 months post-treatment. - Late toxicity (CTCAE v5.0) at 1 and 2 years post-treatment - Patient-reported outcome measures (PROMs) from the EPIC-26, IPSS, and IIEF-5 questionnaires. Patients will be asked to complete PROMs at 4 weeks, 3 and 6 months, 1 and 2 years post treatment. - PSA control and kinetics at 2 years post-treatment Quality of life: EPIC-26 QoL will be measured at baseline, then at 4 weeks and 3, 6, 12 and 24 months from end of treatment. IIEF-5 will be completed at baseline and months 6, 12 and 24. IPSS will be measured at all time points. Follow-up: Patients will be assessed at 6, 12 and 24 months and then as per standard of care.

Criteria for 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 (Grade groups 1, 2 or 3) 4. MRI stage T2 or less (as staged by AJCC TNM 2018) 5. MRI-visible tumour(s) of PIRADS v2 grade 3 or higher on T2 and diffusion-weighted imaging and/or dynamic contrast-enhanced imaging with concordant pathology 6. Dominant lesion <50% of prostate on any axial slice and <50% total prostate volume 7. PSA <20 ng/ml prior to starting ADT 8. Patients can be concurrently treated with androgen deprivation therapy if this would be standard of care. LHRH analogues or Bicalutamide are permitted. ADT is not mandatory where this would usually be omitted. 9. WHO Performance status 0-2 10. Ability of the participant understand and the willingness to sign a written informed consent form. 11. 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 19 or higher 3. High grade disease (GG3) occult to MRI-defined lesion 4. Post-void residual >100 mls, where known 5. Prostate volume >90cc 6. Comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up 7. Unilateral or bilateral total hip replacement, or other pelvic metalwork which causes artefact on diffusion-weighted imaging 8. Previous pelvic radiotherapy 9. Patients needing >6 months of ADT due to disease parameters. 10. 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

Gender: Male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Netherlands Cancer Institute

Address:
City: Amsterdam
Zip: 1066CX
Country: Netherlands

Start date: February 29, 2024

Completion date: April 1, 2027

Lead sponsor:
Agency: The Netherlands Cancer Institute
Agency class: Other

Source: The Netherlands Cancer Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06284304