Radiotherapy Options for Prostate Cancer

(HyBraFi Trial)

Recruiting at 1 trial location

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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare toxicities between 2 external beam radiation fractionation schemes plus a brachytherapy boost for prostate cancer. Our current standard use a 2 Gy per fraction schedule which is compare to the experimental hypofractionated 3 Gy per day approach with neo adjuvant hormonal therapy. It will demonstrate the feasibility and safety of such a treatment regimen in prostate cancer. It may also set base for a larger randomized trial.

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.

What data supports the effectiveness of the treatment HDR Brachytherapy Boost for prostate cancer?

Research shows that using hypofractionated radiotherapy (a method of delivering higher doses of radiation in fewer sessions) can reduce the failure of prostate cancer treatment. Additionally, managing diet to reduce rectal gas and motion can improve the precision of radiotherapy, which is important for effective treatment. ^{1 2 3 4 5}

Is radiotherapy for prostate cancer generally safe for humans?

Preliminary safety results from a trial comparing standard and hypofractionated radiotherapy for prostate cancer suggest that both treatments are generally safe, with manageable side effects. ^{1 3 6 7 8}

How is hypofractionated radiotherapy different from other prostate cancer treatments?

Hypofractionated radiotherapy for prostate cancer uses higher doses of radiation in fewer sessions compared to traditional methods, which can reduce the overall treatment time and may be more convenient for patients. This approach takes advantage of the unique properties of prostate cancer cells, allowing for effective treatment without increasing side effects. ^{9 10 11 12 13}

Research Team

Andre-Guy Martin

Principal Investigator

CHUQ L'Hotel Dieu de Quebec

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Impact of the antifermentative diet during radiotherapy for prostate cancer in elderly, SÃO Paulo, Brazil. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Randomized trial of hypofractionated external-beam radiotherapy for prostate cancer. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Influence of antiflatulent dietary advice on intrafraction motion for prostate cancer radiotherapy. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Seven or less Fractions is Not the Standard of Care for Intermediate-Risk Prostate Cancer. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Impact of a low FODMAP diet on the amount of rectal gas and rectal volume during radiotherapy in patients with prostate cancer - a prospective pilot study. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Nutrition care guidelines for men with prostate cancer undergoing androgen deprivation therapy: do we have enough evidence? [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

Moderately hypofractionated radiotherapy for localized prostate cancer: updated long-term outcome and toxicity analysis. [2021]

8. England 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. [2023]

9. Kuwait pubmed.ncbi.nlm.nih.gov

Hypofractionated Simultaneous Integrated Boost (SIB) versus Conventional Fractionation in Localized Prostate Cancer: A Randomized Pilot Study. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Hypofractioned radiotherapy in prostate cancer: is it the next step? [2018]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Systematic review of hypofractionated radiation therapy for prostate cancer. [2022]

12. United States 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. [2018]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of Hypofractionated Radiotherapy on Patient-reported Outcomes in Prostate Cancer: Results up to 5 yr in the CHHiP trial (CRUK/06/016). [2023]