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 trial explores how different types of high-dose radiation therapy affect urinary quality of life in men with intermediate- or high-risk prostate cancer. It compares standard whole gland radiation with a more targeted approach using high dose-rate brachytherapy (HDR-BT, a type of internal radiation). Men suitable for this trial have a confirmed prostate cancer diagnosis and specific disease features identifiable on advanced imaging, such as MRI. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that High Dose-Rate Brachytherapy (HDR-BT) is generally safe for prostate cancer patients. Studies have found that HDR-BT, whether treating the entire prostate or just a part, is usually well-tolerated. When treating the whole prostate, patients with low- and intermediate-risk prostate cancer have reported few side effects. This method also requires less travel compared to other treatments.

Similarly, using HDR-BT to treat only part of the prostate appears safe, with studies showing it causes few side effects. In some cases, patients who received this focused treatment remained free from cancer progression for over 60% of the time at three years, suggesting effectiveness without major side effects. Both methods appear safe, making them good options for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about high dose-rate brachytherapy (HDR-BT) for prostate cancer because it offers a precise and targeted approach. Unlike traditional external beam radiation therapy, which can affect a broad area, HDR-BT delivers radiation directly to the tumor site, minimizing damage to surrounding healthy tissue. This precision not only potentially reduces side effects but also allows for higher doses of radiation, which can be more effective in destroying cancer cells. Moreover, HDR-BT can be administered in fewer sessions, making it a more convenient option for patients compared to conventional treatments.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

Research shows that high dose-rate brachytherapy (HDR-BT) effectively treats prostate cancer. In this trial, participants will join one of two treatment arms: the Whole Gland High Dose Rate Brachytherapy Boost Arm or the Focal High Dose Rate Brachytherapy Boost Arm. One study found that HDR-BT provided a 75% chance of preventing cancer recurrence over five years, outperforming external beam radiation therapy alone. Another study demonstrated that focusing HDR-BT on a specific prostate area controlled the disease well and posed a low risk of serious side effects. Additionally, HDR-BT can be more convenient for patients, requiring fewer treatment sessions. Overall, these findings suggest HDR-BT could be a promising option for managing prostate cancer with manageable side effects. ^{1 2 4 6 7}

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+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6043748/

High dose-rate brachytherapy in the treatment of prostate cancer

In summary, HDR brachytherapy boost results in a high disease control rates for men with localized prostate cancer, with strong evidence that it provides ...

2.

advancesradonc.com

advancesradonc.com/article/S2452-1094(25)00148-4/fulltext

High-Dose-Rate Brachytherapy Boost for Prostate Cancer

Results showed a 5-year recurrence-free survival of 75% for the HDR-BT boost group versus 61% for the EBRT alone group. An extended 12-year ...

3.

frontiersin.org

frontiersin.org/journals/urology/articles/10.3389/fruro.2025.1598726/full

High-dose-rate brachytherapy lowers travel burden for men ...

HDR-BT monotherapy significantly reduces the travel burden compared with EBRT for localized prostate cancer, with minimal treatment-associated toxicity.

4.

bmjopen.bmj.com

bmjopen.bmj.com/content/13/5/e070020

Efficacy of focal high-dose-rate brachytherapy in ...

Survival without biochemical disease progression after focal HDR BT delivered in one fraction of 19 Gy is not inferior to focal LDR BT (non-inferiority trial). ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2405630820300239

Efficacy and toxicity outcomes for patients treated with focal ...

Focal salvage HDR brachytherapy may provide good biochemical control with a low risk of severe toxicity. Further evaluation within clinical trials are needed to ...

6.

urologytimes.com

urologytimes.com/view/focal-salvage-hdr-brachytherapy-appears-safe-efficacious-in-radiorecurrent-prostate-cancer

Focal salvage HDR brachytherapy appears safe ...

The 3-year biochemical progression-free survival was 61%, and the 3-year radiographic progression-free survival was 67%.

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0167814025046286

A randomized Phase II trial of High Dose-Rate (HDR) and ...

LDR brachytherapy is highly effective for favourable risk prostate cancer. · HDR monotherapy 19 Gy x 1 has a high failure rate. · LDR results in more urinary ...