Radiotherapy Options for Prostate Cancer

(HyBraFi Trial)

Not currently recruiting at 2 trial locations

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: CHU de Quebec-Universite Laval

Must be taking: Hormonal therapy

Disqualifiers: Unfit for biopsy, High risk, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two radiation methods for treating prostate cancer to determine which causes fewer side effects. The standard treatment uses a lower dose of radiation over a longer period, while the experimental method, known as Hypofraction, delivers a higher dose in a shorter time. The research aims to ensure these treatments are safe and effective, potentially paving the way for a larger study. Men diagnosed with prostate cancer, particularly those with intermediate or extensive low-risk cancer and a Gleason score of 7 or less, may be suitable for this trial. As an unphased trial, it offers patients the chance to contribute to pioneering research that could shape future prostate cancer treatments.

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?

Studies have shown that hypofractionated radiotherapy, which involves delivering radiation in larger doses over a shorter period, is generally safe for treating prostate cancer. Research involving over 9,000 men found no significant increase in urinary side effects compared to traditional methods. However, some studies suggest a slight increase in other types of side effects, which are usually mild.

For the brachytherapy boost, which involves placing radioactive material directly in or near the tumor, research indicates it is a safe option for prostate cancer treatment. It has been shown to be effective without causing major side effects. Most patients do not experience severe negative effects from this treatment.

Overall, both treatments have demonstrated a good safety record in previous studies, although some mild side effects may occur. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the hypofraction radiation treatment for prostate cancer because it offers a potentially faster and more convenient approach compared to the standard radiation treatment. Unlike the standard regimen, which involves lower doses delivered over a longer period, hypofraction delivers higher doses in fewer sessions — three Gy daily instead of two Gy. This means patients could complete their treatment in a shorter timeframe. Additionally, the use of firmagon as a neo-adjuvant therapy is noteworthy, offering a different hormonal approach with subcutaneous injections that might enhance the overall treatment effectiveness.

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

This trial will compare different radiotherapy options for prostate cancer. Studies have shown that a shorter, higher-dose radiation treatment, which participants in this trial may receive as part of the Hypofraction arm, works as well as the traditional, longer treatment. One study found that 98% of patients remained alive after five years without dying from the cancer. Other research suggests this method targets cancer cells while protecting healthy ones. It has proven safe and effective even for aggressive types of prostate cancer. Overall, this shorter treatment offers similar survival rates compared to the standard radiation therapy, another treatment option in this trial. ^{6 7 8 9 10}

Who Is on the Research Team?

Andre-Guy Martin

Principal Investigator

CHUQ L'Hotel Dieu de Quebec

Are You a Good Fit for This Trial?

This trial is for up to 30 men with a specific stage of prostate cancer (T1-T2), where the cancer hasn't spread to lymph nodes. They should have a Gleason score of 7 or less, and PSA levels at or below 20. It's not suitable for those needing treatment beyond the prostate.

Inclusion Criteria

I have low-risk prostate cancer that doesn't need treatment in the nodal regions.

My prostate cancer is early stage, with a low Gleason score and PSA level.

Exclusion Criteria

I am not suitable for biopsy or brachytherapy due to my condition.

My prostate cancer is either high or low risk.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive neo-adjuvant hormonal therapy and radiation treatment, including hypofractionated radiotherapy with HDR brachytherapy boost

4 months

Weekly visits for radiation therapy

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up scheduled 6 weeks after the implant and every 4 months for the first year, every 6 months for years 2 to 5, and yearly thereafter

5+ years

Regular follow-up visits as per schedule

What Are the Treatments Tested in This Trial?

Interventions

• HDR Brachytherapy Boost
• Hypofraction
• Standard

Trial Overview The study compares two radiation treatments for prostate cancer: standard therapy using daily doses of radiation versus an experimental approach that gives larger doses less often, both followed by brachytherapy boost and hormone therapy.

How Is the Trial Designed?

Group I: Hypofraction Experimental Treatment 1 Intervention

Patient reported toxicities related to Hypofraction radiation treatment (3 Gy daily, 5 fractions per week) up to a total of 36 Gy to the prostate (+/- seminal vesicles) plus brachytherapy boost (15 Gy in a single fraction) with 4 months neo-adjuvant firmagon (240 mg given as two subcutaneous injections of 120 mg at a concentration of 40 mg/mL as a starting dose with a maintenance dose of 80 mg given as one subcutaneous injection at a concentration of 20 mg/mL administered every 28 days).

Group II: Standard Active Control 1 Intervention

Patient reported toxicities related to the Standard radiation treatment (2 Gy daily, 5 fractions per week) up to a total of 44 Gy to the prostate (+/- seminal vesicles) plus brachytherapy boost (15 Gy in a single fraction) with 4 months neo-adjuvant LHRH agonists.

Who Is Running the Clinical Trial?

CHU de Quebec-Universite Laval

Lead Sponsor

Trials

177

Recruited

110,000+

Ferring Pharmaceuticals

Industry Sponsor

Trials

323

Recruited

1,242,000+

Pierre-Yves Berclaz

Ferring Pharmaceuticals

Chief Medical Officer since 2023

MD from the University of Lausanne, PhD in Molecular Biology from the Cincinnati College of Medicine

Jean-Frédéric Paulsen

Ferring Pharmaceuticals

Chief Executive Officer since 2023

Master’s degree in Finance from the London School of Economics and Political Science

Published Research Related to This Trial

In a study of 45 elderly men undergoing radiotherapy for prostate cancer, the antifermentative diet led to a significant decrease in energy and nutrient intake, including essential vitamins and minerals, during treatment.

Body composition was adversely affected by the diet, with participants experiencing reductions in body weight, arm circumference, and other measurements by the end of radiotherapy, indicating potential negative impacts on overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of the antifermentative diet during radiotherapy for prostate cancer in elderly, SÃO Paulo, Brazil. de Oliveira Pedron, ÉL., de Cássia de Aquino, R., Borin da Silva, C.[2021]

In a study involving 457 men with localized prostate cancer, hypofractionated high-dose radiotherapy (60 Gy and 57 Gy) was found to be as well tolerated as conventional radiotherapy (74 Gy) over a median follow-up of 50.5 months, with low rates of grade 2 or worse bowel and bladder toxicities.

The rates of bowel toxicity were 4.3% for the conventional group, 3.6% for the 60 Gy group, and 1.4% for the 57 Gy group, indicating that hypofractionated treatment may not increase the risk of side effects compared to standard treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: preliminary safety results from the CHHiP randomised controlled trial. Dearnaley, D., Syndikus, I., Sumo, G., et al.[2023]

A review of 16 studies on dietary interventions for men undergoing androgen deprivation therapy (ADT) for prostate cancer found limited evidence supporting their effectiveness, with only one study showing that daily caffeinated beverages helped reduce cancer-related fatigue.

Most studies combined diet with other interventions like physical activity or medication, and there was a lack of consistent reporting on dietary intake, making it difficult to assess the feasibility and acceptability of these dietary changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition care guidelines for men with prostate cancer undergoing androgen deprivation therapy: do we have enough evidence? Barnes, KA., Ball, LE., Galvão, DA., et al.[2020]

This ongoing phase II clinical study is investigating an ultra-hypofractionated radiotherapy scheme for low- or intermediate-risk prostate cancer patients, focusing on the feasibility and incidence of acute side effects.

The study aims to assess not only the immediate tolerability of the treatment but also its long-term effects on quality of life and oncological outcomes, with expectations of good tolerability and effectiveness based on previous research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and protocol of AIRC IG-13218, short-term radiotherapy for early prostate cancer with concomitant boost to the dominant lesion. Timon, G., Ciardo, D., Bazani, A., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5002023/

Treatment outcomes with hypofractionated high-dose ... The 5-year overall survival rate was 92%. Only 1 patient died from the disease at 48 months after treatment, giving a 5-year cancer-specific survival of 98%.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1558767324000739

10-yr Results of Moderately Hypofractionated ... Our study provides long term data that a shortened course of postoperative RT is as safe and effective as a long course of conventionally fractionated RT.

3. ascopubs.org ascopubs.org/doi/10.1200/GO.23.00046

Hypofractionation Adoption in Prostate Cancer Radiotherapy Several large randomized trials have consistently shown that a hypofractionated radiation therapy regimen is noninferior to conventionally ...

4. mdpi.com mdpi.com/2673-592X/4/4/29

Exploring Hypofractionated Radiotherapy Efficacy in ... The findings indicate that hypofractionation may help preserve non-cancerous cells while potentially improving outcomes for aggressive prostate cancer types.

5. oncologynurseadvisor.com oncologynurseadvisor.com/features/moderately-hypofractionated-radiotherapy-in-prostate-cancer/

Hypofractionated Radiotherapy in Prostate Cancer Both isodose & dose-escalated MHFRT offer rates of progression-free & overall survival comparable to those seen with conventional ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38160102/

Safety of high-dose rate (HDR) brachytherapy for patients ... Conclusions: HDR-BT is a safe treatment for patients with prostate cancer who previously received RT for rectal cancer. Further studies are ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2405630825000138

Effectiveness, toxicity and impact on quality of life of high ... High-dose-rate brachytherapy is an option for prostate cancer patients. •. Two fractions of high-dose-rate brachytherapy as monotherpy appear to be safe. •.

8. thegreenjournal.com thegreenjournal.com/article/S0167-8140(24)00651-0/fulltext

Prostate high dose-rate brachytherapy as monotherapy for ... Multi-fraction high dose-rate brachytherapy (HDR) has emerged as a safe and effective monotherapy for patients with intermediate-risk prostate ...

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

High-Dose-Rate Brachytherapy Boost for Prostate Cancer a single high-dose-rate (HDR) of 15 Gy combined with external radiation therapy of 40 to 50 Gy results in disease-free survival of over 90% for intermediate- ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12190164/

Long-Term Outcomes After High-Dose-Rate Brachytherapy ... These outcomes included lower biochemical recurrence-free survival at 5 and 8 years, lower OS, and lower prostate CSS compared to patients with ...