Ultra-Hypofractionated Radiotherapy + Brachytherapy for Prostate Cancer

(HYPO-5 Trial)

Recruiting at 1 trial location

Overseen By Josee Allard

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: CHU de Quebec-Universite Laval

Must not be taking: Alpha-blockers

Disqualifiers: T3 or T4 stage, N1, M1, PSA > 20, Gleason 8-10, others

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

Compensation: Varies

Number of Visits: 5

205 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to treat prostate cancer using different types of radiation therapy. It compares two methods: ultra-hypofractionated radiotherapy (fewer, higher doses) and moderately hypofractionated radiotherapy (more sessions with moderate doses), both combined with brachytherapy, a special internal radiation technique. The researchers aim to determine if the newer method is as safe and effective as the traditional one, focusing on side effects and long-term outcomes. Men with prostate cancer that hasn't spread beyond certain stages and who have specific PSA levels and Gleason scores are suitable candidates for this study. As an unphased trial, this study allows patients to contribute to innovative 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. However, if you are taking alpha-blocking medication and have an IPSS Score over 20, you may not be eligible for the trial.

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

Research shows that combining ultra-hypofractionated radiotherapy with high-dose-rate (HDR) brachytherapy is safe for treating prostate cancer. Studies have found that this combination shortens treatment time and reduces the burden on patients. Importantly, these studies identified no major safety issues.

HDR brachytherapy alone is a well-known treatment for prostate cancer. It effectively controls the disease, targeting and managing the cancer well. This treatment is considered safe and effective, especially for patients with intermediate- and high-risk prostate cancer.

Overall, both ultra-hypofractionated radiotherapy and HDR brachytherapy have demonstrated safety. They are generally well-tolerated and do not cause severe side effects in most patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring ultra-hypofractionated radiotherapy combined with brachytherapy for prostate cancer because it offers a potentially faster and more precise treatment compared to standard options. Unlike traditional radiotherapy, which can take several weeks, this approach delivers a high dose of radiation in just a few sessions, targeting the prostate and nearby areas with great precision. This condensed schedule could lead to fewer hospital visits and less disruption to patients' lives. Additionally, the combination with HDR brachytherapy might enhance effectiveness by delivering radiation directly to the tumor site, potentially improving outcomes while minimizing side effects.

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

This trial will compare ultra-hypofractionated radiotherapy with moderately hypofractionated radiotherapy for prostate cancer. Research has shown that ultra-hypofractionated radiotherapy, combined with high dose-rate (HDR) brachytherapy, effectively treats prostate cancer. One study found that this combination provided excellent disease control, with 93.3% of patients showing no signs of cancer in their blood tests and 95.2% experiencing no cancer growth in the prostate over ten years. This treatment is safe, shortens therapy time, and is less burdensome for patients. Additionally, using HDR brachytherapy with this radiation method results in fewer urinary side effects. These findings suggest that this treatment can be a strong option for managing localized prostate cancer. ^{1 2 3 6 7}

Who Is on the Research Team?

Andre-Guy Martin

Principal Investigator

CHU de Québec

Are You a Good Fit for This Trial?

Men with early-stage prostate cancer (Stage T1c or T2), no spread to lymph nodes or distant organs, PSA levels below 20ng/ml, and a Gleason Score of 6 or 7. Participants must be able to give written consent. Excluded are those with advanced disease stages, high Gleason Scores (8-10), severe urinary symptoms, prior pelvic radiotherapy, bilateral hip prosthesis, under age 18, inflammatory bowel disease history, or active collagen diseases.

Inclusion Criteria

PSA < 20ng/ml

My prostate cancer was confirmed through a biopsy.

My cancer is at an early stage, but not the earliest.

Exclusion Criteria

I have a history of autoimmune diseases like Lupus.

I have a history of inflammatory bowel disease.

I have had radiation therapy to my pelvic area before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Brachytherapy

Participants undergo brachytherapy with implantation under anesthesia, followed by dosimetric optimization and dose delivery

1 week

Multiple visits for implantation and monitoring

Radiotherapy

Participants receive radiotherapy via IMRT, VMAT, or SBRT techniques, with a dose of 25 Gy in 5 fractions over 7 days

1 week

5 visits (in-person)

Follow-up

Participants are monitored for toxicity and quality of life outcomes, with assessments at 3, 6, 12 months, and yearly up to 5 years

5 years

Regular follow-up visits as needed

What Are the Treatments Tested in This Trial?

Interventions

• HDR Brachytherapy Boost
• Moderately Hypofractionnated Radiotherapy
• Ultra Hypofractionnated Radiotherapy

Trial Overview This Phase 1-2 study compares two types of radiation therapy for prostate cancer: ultra-hypofractionnated versus moderately hypofractionnated therapy combined with image-guided HDR brachytherapy. The goal is to determine if the shorter treatment is just as safe as the longer one in terms of side effects over time.

How Is the Trial Designed?

Group I: ultra hypo fractionation radiation therapy Experimental Treatment 1 Intervention

comparative PRO's of 25 Gy in 5 daily fractions (Ultra hypo fractionation) administered to prostate and 1st centimeter of proximal seminal vesicle, starting mid week and ending mid following week.

Group II: moderate hypo fractionation radiation therapy Active Control 1 Intervention

PRO's of moderate hypo fractionation, 37,5 Gy in 15 or 36 Gy in 12 daily fractions administered 5 days per week.

HDR Brachytherapy Boost is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as HDR Brachytherapy for:

• Prostate cancer
• Cervical cancer
• Uterine cancer
• Vaginal cancer
• Rectal cancer
• Esophageal cancer
• Lung cancer
• Breast cancer
• Skin cancer

Approved in United States as HDR Brachytherapy for:

• Prostate cancer
• Cervical cancer
• Uterine cancer
• Vaginal cancer
• Rectal cancer
• Esophageal cancer
• Lung cancer
• Breast cancer
• Skin cancer

Approved in Canada as HDR Brachytherapy for:

• Prostate cancer
• Cervical cancer
• Uterine cancer
• Vaginal cancer
• Rectal cancer
• Esophageal cancer
• Lung cancer
• Breast cancer
• Skin cancer

Approved in Japan as HDR Brachytherapy for:

• Prostate cancer
• Cervical cancer
• Uterine cancer
• Vaginal cancer
• Rectal cancer
• Esophageal cancer
• Lung cancer
• Breast cancer
• Skin cancer

Who Is Running the Clinical Trial?

CHU de Quebec-Universite Laval

Lead Sponsor

Trials

177

Recruited

110,000+

Published Research Related to This Trial

In a clinical trial involving 42 men with intermediate-risk prostate cancer, a treatment combining a single 15 Gy HDR brachytherapy boost with a five-fraction external beam radiation therapy (EBRT) resulted in a high biochemical disease-free survival rate of 95.5% after a median follow-up of 36 months.

The treatment demonstrated low toxicity, with only one case of acute Grade 3 gastrointestinal and genitourinary toxicity, and no significant differences in health-related quality of life across urinary, bowel, or sexual domains, suggesting it is a safe and effective option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase IB clinical trial of 15 Gy HDR brachytherapy followed by hypofractionated/SBRT in the management of intermediate-risk prostate cancer. Den, RB., Greenspan, J., Doyle, LA., et al.[2023]

In a study of 164 men treated with high-dose-rate (HDR) brachytherapy for prostate cancer, the procedure showed a low incidence of genitourinary (GU) and gastrointestinal (GI) complications, indicating it is a safe treatment option.

With a median follow-up of 18.6 months, HDR brachytherapy resulted in a high overall survival rate of 98.7% and a disease-free survival rate of 96.2%, demonstrating its efficacy in treating localized prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building a High-Dose-Rate Prostate Brachytherapy Program With Real-Time Ultrasound-Based Planning: Initial Safety, Quality, and Outcome Results. Zhang, H., Kang, S., Ali, N., et al.[2022]

High-dose-rate brachytherapy (HDR) combined with external beam radiotherapy shows high efficacy in treating prostate cancer, with relapse-free survival rates exceeding 90% for intermediate-risk patients and over 80% for high-risk patients, outperforming external beam radiotherapy alone.

A specific regimen of a single 15 Gy HDR boost along with 37.5 Gy of hypofractionated radiotherapy is well tolerated and can be completed in under 90 minutes, making it a quick and efficient treatment option for men with high and intermediate risk prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose-rate brachytherapy boost for prostate cancer: rationale and technique. Morton, GC.[2022]

High-dose-rate brachytherapy (HDR-BT) delivers a significantly higher dose to the planning target volume (PTV) compared to both robotic and conventional stereotactic body radiotherapy (SBRT), indicating its potential for more effective treatment of prostate cancer.

HDR-BT results in lower radiation exposure to the bladder and rectum than SBRT, which may reduce the risk of side effects, although it does expose the urethra to a higher dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment planning comparison of high-dose-rate brachytherapy vs. robotic and conventional stereotactic body radiotherapy for ultrahypofractionated treatment of prostate cancer. Yoshioka, Y., Sasamura, K., Ito, M., et al.[2023]

Extreme hypofractionation, which involves delivering large doses of radiation in fewer sessions, may be particularly effective for prostate cancer due to the tumor's low sensitivity to radiation and high ability to repair damage.

Both high-dose rate brachytherapy (HDR-BT) and stereotactic body radiotherapy (SBRT) are promising methods for this approach, but further research is needed to ensure effective dose distribution and minimize treatment duration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for prostate cancer: treatment approaches and clinical outcomes. Miralbell, R.[2020]

High dose rate (HDR) brachytherapy combined with external beam radiation therapy has been shown to be a safe and effective treatment for intermediate and high-risk prostate cancer, leading to a significant increase in treatment options and outcomes.

The success of HDR brachytherapy has prompted its use as a standalone treatment for low to intermediate-risk prostate cancer, supported by excellent toxicity profiles and clinical results from ongoing research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of high dose rate brachytherapy in the treatment of prostate cancer. Ghilezan, M.[2012]

In a study of 148 prostate cancer patients treated with high-dose-rate (HDR) brachytherapy followed by intensity-modulated radiation therapy (IMRT), the treatment showed a high 4-year biochemical disease-free survival (bDFS) rate of 96.8% using the Phoenix criteria.

The treatment was well tolerated, with low rates of genitourinary (10%) and gastrointestinal (5%) toxicities, indicating that this combination therapy is both effective and safe for patients in a community setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Four-year outcomes of hypofractionated high-dose-rate prostate brachytherapy and external beam radiotherapy. Chen, WC., Tokita, KM., Ravera, J., et al.[2018]

A retrospective analysis of 214 prostate cancer patients treated with high dose rate brachytherapy (HDR-BT) combined with external beam radiotherapy showed an overall 5-year biochemical no evidence of disease (bNED) rate of 82%, indicating effective treatment outcomes.

The study found that HDR-BT is safe, with few severe late complications, primarily urethral stricture in 13 patients, and no severe rectal complications, supporting its use for dose escalation in localized prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcome of high dose rate brachytherapy in radiotherapy of localised prostate cancer. Aström, L., Pedersen, D., Mercke, C., et al.[2005]

The ultra-hypofractionated (UHF) radiation therapy regimen combined with HDR brachytherapy boost showed no significant differences in gastrointestinal or genitourinary side effects compared to moderate-hypofractionated regimens, indicating similar safety profiles.

No biochemical recurrences were observed in the UHF treatment group over a median follow-up of 48.5 months, suggesting effective local control of prostate cancer comparable to standard treatment regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of four-year toxicities and local control of ultra-hypofractionated vs moderate-hypofractionated image guided prostate radiation with HDR brachytherapy boost: A phase I-II single institution trial. Beaudry, MM., Carignan, D., Foster, W., et al.[2023]

Ultrahypofractionated radiotherapy, which involves delivering treatment in five to seven fractions, is becoming a standard practice for localized prostate cancer, showing promise for even fewer fractions.

Evidence suggests that localized prostate cancer can be safely and effectively treated in fewer than five fractions using techniques like high dose rate brachytherapy or stereotactic body radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrahypofractionated Radiotherapy for Localised Prostate Cancer: How Far Can We Go? Corkum, MT., Achard, V., Morton, G., et al.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S016781402505203X

Ultra-hypofractionated radiotherapy combined with HDR ... Conclusion. Our study confirms UHF with HDR-BB is safe for intermediate-risk prostate cancer, reducing treatment time and patient burden. Longer ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05786742

Ultra Hypofractionnated Radiotherapy With HDR ... Phase 1-2 study, comparing ultra-hypofractionnated (UH) to a moderately hypofractionnated (MH) radiation therapy, with image guided HDR prostate ...

3. thegreenjournal.com thegreenjournal.com/article/S0167-8140(23)00345-6/abstract

Long-term outcomes of ultra-hypofractionated 2 fractions ... 2 Fractions HDR-BT single day for localized PCa is highly curative. ... 10-yrs biochemical and local control were 93.3%, and 95.2%, respectively.

4. 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 ...

5. estro.org estro.org/About/Newsroom/Newsletter/Brachytheraphy/Combined-brachytherapy-and-ultra-hypofractionated

Combined brachytherapy and ultra-hypofractionated ... The application of HDR brachytherapy combined with ultra-hypofractionated radiation therapy (UHRT) was associated with significantly less urinary toxicity than ...

6. nature.com nature.com/articles/s41598-022-09120-0

Comparison of toxicities between ultrahypofractionated ... Randomised trial of external-beam radiotherapy alone or with high-dose-rate brachytherapy for prostate cancer: Mature 12-year results. Radiother ...

7. brachyjournal.com brachyjournal.com/article/S1538-4721(25)00117-5/fulltext

High-dose-rate (HDR) brachytherapy boost in combination ... For men with intermediate- and high-risk prostate cancer, HDR brachytherapy boost is a safe and effective technique for dose-escalation that can achieve ...