Brachytherapy for Prostate Cancer

(FORWARD Trial)

Overseen By Joelle Helou, MD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Joelle Helou

Disqualifiers: Metastases, Previous pelvic radiotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This project aims to compare the changes in the urinary quality of life (QoL) following focal high dose-rate brachytherapy (HDR-BT) boost to stereotactic ablative radiotherapy (SABR), compared to standard whole gland HDR-BT boost, in the treatment of men diagnosed with intermediate- and high-risk prostate cancer, with have an identifiable DIL on mpMRI.

Who Is on the Research Team?

Joelle Helou, MD

Principal Investigator

London Health Sciences Centre Research Institute, London Health Sciences Centre

Are You a Good Fit for This Trial?

Men with intermediate- or high-risk prostate cancer, who have a detectable lesion on mpMRI, are eligible for this trial. The study is designed to assess the impact of two types of radiotherapy on urinary quality of life.

Inclusion Criteria

I can take care of myself and am up and about more than 50% of my waking hours.

My prostate cancer is at an early but aggressive stage, with specific features.

My prostate cancer diagnosis was confirmed through a tissue examination.

Exclusion Criteria

I had recent prostate surgery or treatment within the last 6 months.

Contraindications to mpMRI

Patients deemed unsuitable for general anaesthetic by the Anaesthesia Department

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive focal or whole gland high dose-rate brachytherapy (HDR-BT) boost with external beam radiotherapy

6-8 weeks

Follow-up

Participants are monitored for changes in urinary, bowel, and sexual quality of life, as well as physician-reported toxicity

24 months

Long-term Follow-up

Participants are monitored for prostate-specific antigen (PSA) levels

4 years

What Are the Treatments Tested in This Trial?

Interventions

• High Dose-Rate Brachytherapy (HDR-BT)

Trial Overview

The trial compares two treatments: the standard whole gland HDR-BT boost and an experimental focal HDR-BT boost. Both are combined with external beam radiotherapy to see which better preserves urinary quality of life.

How Is the Trial Designed?

Group I: Focal High Dose Rate Brachytherapy Boost Arm Experimental Treatment 1 Intervention

Group II: Whole Gland High Dose Rate Brachytherapy Boost Arm Active Control 1 Intervention

Who Is Running the Clinical Trial?

Joelle Helou

Lead Sponsor

London Health Sciences Centre

Collaborator

Trials

151

Recruited

60,400+