Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT06177093

De-escalated Dose SBRT in Localized Prostate Cancer (DESTINATION-MRL)

Led by Sunnybrook Health Sciences Centre · Updated on 2024-01-26

20

Participants Needed

1

Research Sites

207 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 MRI) 5 fraction SBRT to the prostate. Trial Objectives are: 1. Primary To develop a 5 fraction de-escalated dose SBRT protocol capable of reducing side effects 2. 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

CONDITIONS

Official Title

De-escalated Dose SBRT in Localized Prostate Cancer (DESTINATION-MRL)

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Men aged 6 years
  • Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy
  • Gleason score of 3+3, 3+4, or 4+3 (Grade groups 1, 2, or 3)
  • MRI stage T2 or less according to AJCC TNM 2018
  • MRI-visible tumor(s) of PIRADS v2 grade 3 or higher on multiparametric MRI with matching pathology
  • Tumor nodule visible on MRI occupying less than 50% of the prostate on any axial slice and less than 50% prostate volume
  • PSA less than 20 ng/ml before starting androgen deprivation therapy (if applicable)
  • Short course (less than 6 months) concurrent androgen deprivation therapy allowed but not required
  • WHO Performance status between 0 and 2
  • Ability to understand and willing to sign informed consent
  • Ability and willingness to complete patient-reported outcome questionnaires throughout the study
Not Eligible

You will not qualify if you...

  • Contraindications to MRI such as pacemaker, mobile metal implant, or claustrophobia
  • International Prostate Symptom Score (IPSS) of 19 or higher
  • High grade disease (Grade Group 3) not visible on MRI-defined lesion
  • Post-void residual urine volume greater than 100 ml, if known
  • Prostate volume greater than 90 cc
  • Comorbidities that increase risk of toxicity or prevent long-term follow-up, such as inflammatory bowel disease
  • Unilateral or bilateral total hip replacement or other pelvic metalwork causing imaging artifacts
  • Previous pelvic radiotherapy
  • Need for more than 6 months of androgen deprivation therapy based on disease parameters
  • Previous invasive cancer within 2 years except certain skin cancers, low-risk bladder cancer with negative follow-up, or small renal masses under surveillance

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N 3M5

Actively Recruiting

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Research Team

D

Danny Vesprini, M.D.

CONTACT

M

Murtuza Saifuddin, M.S.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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