Status:
RECRUITING
De-escalated Dose SBRT in Localized Prostate Cancer (DESTINATION-MRL)
Lead Sponsor:
Sunnybrook Health Sciences Centre
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
This study is a single centre feasibility trial. The trial will recruit men with intermediate risk localised prostate cancer who will all receive targeted dose (escalated/de-escalated dose directed by...
Detailed Description
TRIAL POPULATION: Men with intermediate risk localized prostate cancer TRIAL TREATMENT: All radiotherapy will be delivered on the MR-linac. Intraprostatic dose will be varied according to risk of loca...
Eligibility Criteria
Inclusion
- 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 PIRADS v2 grade 3 or higher on T2 and diffusion-weighted imaging and/or dynamic contrast-enhanced imaging (multiparametric MRI or mpMRI) with concordant pathology
- Tumour nodule visible on MRI occupying \<50% of prostate on any axial slice and \<50% prostate volume
- PSA \<20 ng/ml prior to starting ADT (if applicable)
- Short course (\< 6 months) concurrent androgen deprivation therapy (antiandrogens or LHRH analogues) allowed though not mandated as per the discretion of the treating physician.
- 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
- 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 as per the discretion of the treating physician
- 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.
Key Trial Info
Start Date :
December 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06177093
Start Date
December 11 2023
End Date
December 1 2027
Last Update
January 26 2024
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5