HDR Brachytherapy for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: CSSS de Gatineau

Disqualifiers: Advanced prostate cancer, High PSA, 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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called HDR brachytherapy for men with low or intermediate risk prostate cancer. The goal is to evaluate the effectiveness of this radiation treatment and monitor any side effects. Participants will receive two doses of radiation with a short break in between. The trial seeks men diagnosed with prostate cancer, specifically those with certain lab test results and no history of other major pelvic health conditions. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for this trial?

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 prior data suggests that HDR brachytherapy is safe for prostate cancer treatment?

Research has shown that HDR brachytherapy is generally safe for treating prostate cancer. Studies have found that patients usually tolerate it well. In one study, HDR brachytherapy did not cause severe side effects in individuals who had previously received radiation for rectal cancer, suggesting it can be safely used even in patients with prior treatments.

HDR brachytherapy is already a common treatment in the U.S. and Europe when combined with external radiation, indicating a strong safety record. As a standard treatment, there is confidence in its safety for prostate cancer, even though this trial tests it independently.

In summary, evidence suggests that HDR brachytherapy is a safe option for prostate cancer, with no major safety concerns reported in existing research. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prostate cancer?

HDR brachytherapy is unique because it offers a more targeted approach to treating prostate cancer compared to conventional external beam radiation therapy. This treatment involves using high-dose radiation implants directly in the prostate, delivering a concentrated dose of 13.5 Gray (Gy) in just two sessions with a short interval between them. Researchers are excited about this method because it potentially reduces the treatment duration and minimizes exposure to surrounding healthy tissues, which could lead to fewer side effects and improved patient outcomes.

What evidence suggests that HDR brachytherapy might be an effective treatment for prostate cancer?

Research has shown that HDR brachytherapy holds promise for treating prostate cancer. One study found it effectively controlled the disease in men with localized prostate cancer. In this trial, participants will receive HDR brachytherapy as monotherapy, administered in two separate sessions. These findings suggest that HDR brachytherapy is a strong option for managing low to intermediate-risk prostate cancer. Overall, this treatment has the potential to control the disease while reducing side effects. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for men with prostate cancer that's not too advanced. Specifically, it's for those who've had a biopsy confirming Adenocarcinoma of the Prostate at an early stage (T1c, T2a or T2b), have a PSA level under 20 ng/ml, and a Gleason Score of 6 or 7.

Inclusion Criteria

My prostate cancer has a Gleason score of 6 or 7.

PSA less than 20 ng/ml

My prostate cancer is confirmed by a biopsy.

Exclusion Criteria

My IPSS score is 19 or higher, and I am taking alpha-blockers.

I have had radiation therapy to my pelvic area.

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Treatment with 2 separate HDR brachytherapy implants, each with one fraction of 13.5 Gray (Gy) with an interval of 7-14 days between treatments

2-4 weeks

Follow-up

Participants are monitored for genito-urinary and gastro-intestinal toxicity, as well as disease-free survival

5 years

What Are the Treatments Tested in This Trial?

Interventions

• HDR Brachytherapy

Trial Overview The study is testing if High-dose rate (HDR) brachytherapy alone can be effective in treating low to intermediate risk prostate cancer. HDR brachytherapy involves placing high-energy radiation sources inside the prostate to kill cancer cells.

How Is the Trial Designed?

Group I: HDR brachytherapy monotherapy Experimental Treatment 1 Intervention

Radiation therapy: Treatment with 2 separate HDR brachytherapy implants, each with one fraction of 13.5 Gray (Gy) with an interval of 7-14 days between treatments.

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

Approved in European Union as HDR Brachytherapy for:

• Localized prostate cancer
• Locally advanced prostate cancer
• Recurrent prostate cancer

Approved in United States as HDR Brachytherapy for:

• Prostate cancer
• Recurrent prostate cancer

Approved in Canada as HDR Brachytherapy for:

• Localized prostate cancer
• Locally advanced prostate cancer
• Recurrent prostate cancer

Who Is Running the Clinical Trial?

CSSS de Gatineau

Lead Sponsor

Trials

2

Recruited

250+

Published Research Related to This Trial

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 (HDR) brachytherapy is a safe and effective treatment for low-risk prostate cancer, with 45% of patients experiencing some form of acute toxicity, primarily grade 1 urinary toxicity, within three months post-treatment.

The study found that urinary toxicity was significantly linked to the dose received by the urethra, with patients receiving over 111.3% of the prescribed dose being four times more likely to experience urinary issues, highlighting the importance of careful dose management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose-rate brachytherapy delivered in two fractions as monotherapy for low-risk prostate cancer. Cendales, R., Alwers, E., Cifuentes, J., et al.[2020]

In a randomized phase II trial involving 170 patients with localized prostate cancer, HDR brachytherapy delivered in two fractions of 13.5 Gy resulted in significantly better 5-year biochemical disease-free survival (95%) compared to a single fraction of 19 Gy (73.5%).

The two-fraction treatment was well tolerated, with low rates of late rectal toxicity (1%) and manageable urinary toxicity (45% grade 2), indicating it is a safe and effective option for prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate high dose-rate brachytherapy as monotherapy for low and intermediate risk prostate cancer: Efficacy results from a randomized phase II clinical trial of one fraction of 19 Gy or two fractions of 13.5 Gy. Morton, G., McGuffin, M., Chung, HT., et al.[2021]

High-dose-rate (HDR) brachytherapy shows excellent biochemical control rates for localized prostate cancer, achieving 85-100% for low-risk, 81-100% for intermediate-risk, and 43-93% for high-risk cases, based on a comprehensive review of literature.

Severe toxicity from HDR brachytherapy is rare, with less than 5% of patients experiencing Grade 3 or higher side effects, highlighting its safety as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

American Brachytherapy Society consensus guidelines for high-dose-rate prostate brachytherapy. Yamada, Y., Rogers, L., Demanes, DJ., et al.[2022]

High Dose Rate Brachytherapy (HDR-BT) is effective for treating prostate cancer, initially used as a boost to external beam therapy but now also as a standalone treatment (HDR monotherapy).

The review highlights clinical outcomes and toxicity results from key studies, supporting the use of HDR-BT based on its favorable physical and radiobiological characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is high dose rate brachytherapy reliable and effective treatment for prostate cancer patients? A review of the literature. De Bari, B., Daidone, A., Alongi, F.[2018]

High-dose-rate (HDR) brachytherapy as a monotherapy in two fractions within one day is feasible for treating localized prostate cancer, including high-/very high-risk cases, with a median follow-up of 30.1 months showing minimal adverse events (AEs).

The treatment resulted in a high biochemical failure-free survival rate of 91.6% overall and 88.0% for high-/very high-risk patients, indicating effective disease control with acceptable safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and early outcome of high-dose-rate Ir-192 brachytherapy as monotherapy in two fractions within 1 day for high-/very high-risk prostate cancer. Ashida, S., Yamasaki, I., Tamura, K., et al.[2020]

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]

In a study of 623 prostate cancer patients treated with high-dose-rate brachytherapy (HDR-BT) and external beam radiotherapy (EBRT), the 10-year prostate cancer-specific survival rates were excellent, reaching 100% for low-risk patients and 75% for very high-risk patients, indicating effective long-term tumor control.

While the treatment showed manageable levels of toxicity, with 28% experiencing grade 2 genitourinary (GU) toxicities and 12% experiencing gastrointestinal (GI) toxicities, the incidence of severe GU complications was notably higher in patients treated before 2003, highlighting the importance of dose constraints to minimize side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two decades of high dose rate brachytherapy with external beam radiotherapy for prostate cancer. Åström, L., Grusell, E., Sandin, F., et al.[2018]

High-dose-rate (HDR) brachytherapy for early-stage prostate cancer showed excellent outcomes, with a 100% biochemical progression-free survival rate and no severe toxicities (grade ≥3) reported among 39 patients followed for a median of 57 months.

While HDR treatment is generally safe, factors such as larger prostate size and higher doses to the urethra and bladder can lead to worse short-term urinary quality of life, and older patients may experience more significant sexual function impairment both shortly after treatment and in the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient- and treatment-specific predictors of genitourinary function after high-dose-rate monotherapy for favorable prostate cancer. Raleigh, DR., Chang, AJ., Tomlin, B., et al.[2022]

Patients with intermediate- to high-risk prostate cancer who received a high-dose-rate (HDR) brachytherapy boost along with 3D conformal radiotherapy (3DCRT) showed significantly better overall survival rates at 5, 10, and 15 years compared to those who received 3DCRT alone, with survival rates of 92%, 81%, and 67% versus 88%, 71%, and 53%, respectively.

The HDR boost group also demonstrated improved cause-specific survival rates, indicating that this treatment combination not only prolongs life but also effectively targets cancer progression, with cause-specific survival rates of 96%, 93%, and 87% for the HDR group compared to 95%, 88%, and 79% for the 3DCRT group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved survival for patients with prostate cancer receiving high-dose-rate brachytherapy boost to EBRT compared with EBRT alone. Kent, AR., Matheson, B., Millar, JL.[2019]

High-dose-rate (HDR) brachytherapy is recognized as a potentially curative treatment for prostate cancer, with a consensus reached by an expert panel on its clinical applications based on a thorough review of recent literature.

The panel developed three clinical variants to guide the use of HDR brachytherapy, addressing different dosing and treatment indications for both primary and recurrent prostate cancer, which can help practitioners apply these guidelines effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ACR Appropriateness Criteria high-dose-rate brachytherapy for prostate cancer. Hsu, IC., Yamada, Y., Assimos, DG., et al.[2022]

High-dose rate brachytherapy (HDR-BT) shows high efficacy as a monotherapy for localized prostate cancer, with local control rates between 97-100% and biochemical progression-free survival rates of 85-100% for low-risk patients and 79-92% for high-risk patients based on a systematic review of 14 studies.

While HDR-BT is generally safe, most studies reported acute and long-term genitourinary complications, which were more common and severe than gastrointestinal issues, indicating a need for further research on long-term safety and efficacy, especially in high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose rate brachytherapy as monotherapy in prostate cancer: A systematic review of its safety and efficacy. Sánchez-Gómez, LM., Polo-deSantos, M., Rodríguez-Melcón, JI., et al.[2022]

In a study involving 293 patients with intermediate and high-risk localized prostate cancer, a single high-dose-rate brachytherapy (HDR-BT) treatment of 19-20Gy showed comparable biochemical relapse-free survival rates (94% for 1×19Gy and 93% for 1×20Gy) to multi-fraction treatments (93% for 2×13Gy and 91% for 3×10.5Gy) over a median follow-up of up to 108 months.

The single-dose HDR-BT resulted in low rates of late genitourinary (GU) and gastrointestinal (GI) morbidity, with no grade-4 complications observed, indicating it is a safe and effective treatment option for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-dose high-dose-rate brachytherapy compared to two and three fractions for locally advanced prostate cancer. Hoskin, P., Rojas, A., Ostler, P., et al.[2022]

High-dose-rate (HDR) brachytherapy is a new and promising treatment for prostate cancer that offers potential benefits in radiation physics and radiobiology.

The article outlines the technique for using HDR brachytherapy as a standalone treatment, emphasizing its innovative approach, although clinical results are still developing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose-rate brachytherapy as monotherapy for prostate cancer: technique, rationale and perspective. Yoshioka, Y., Suzuki, O., Otani, Y., et al.[2021]

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. sciencedirect.com sciencedirect.com/science/article/pii/S2452109425001484

High-dose-rate brachytherapy boost for prostate cancer: A ... Overall, this study demonstrated the efficacy of EBRT-boosted brachytherapy in the treatment of intermediate- and high-risk prostate cancer, ...

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

Prostate high dose-rate brachytherapy as monotherapy for ... We report on the efficacy of a randomized Phase II trial comparing HDR monotherapy delivered as 27 Gy in 2 fractions vs. 19 Gy in 1 fraction with a median ...

4. link.springer.com link.springer.com/article/10.1007/s11604-024-01621-4

Long-term outcomes of high-dose-rate brachytherapy and ... Our study demonstrated that HDR-BT in combination with EBRT without additional HT resulted in 7-year bFFF, CSS, and OS rates of 74.2, 100, and ...

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

Long-Term Outcomes After High-Dose-Rate Brachytherapy ... The 24-year outcomes support the viability and therapeutic efficacy of EBRT combined with a conformal HDR-BT boost for patients with VHR PCa.

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. clinicaltrials.gov clinicaltrials.gov/study/NCT01655836

High-Dose Rate Brachytherapy and Stereotactic Body ... HDR brachytherapy is a standard of care in the United States and Europe to deliver a radiation boost to the prostate when combined with external beam radiation.