HDR Brachytherapy for Prostate Cancer

(SalvageHDR Trial)

Overseen By Francois Bachand, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: British Columbia Cancer Agency

Disqualifiers: Inflammatory bowel disease, Rectal surgery, others

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

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

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests high-dose-rate (HDR) brachytherapy for men whose prostate cancer returned after initial radiation therapy. HDR brachytherapy places a small, radioactive source directly at the site of cancer recurrence inside the prostate to deliver a high dose of radiation. The trial aims to determine if this method can effectively control the cancer after it returns. Suitable candidates have had previous radiation treatment for prostate cancer, show a rising PSA level (a marker used to track prostate cancer), and have cancer that can be targeted with this therapy. As an unphased trial, this study provides a unique opportunity for patients to explore innovative treatment options that could potentially improve their outcomes.

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

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that Androgen Deprivation Therapy can be started if your doctor thinks it's necessary.

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

Research shows that high-dose-rate (HDR) brachytherapy is generally safe for treating prostate cancer. Studies have found that HDR brachytherapy can effectively control the disease for many men. For example, one study reported that 97% of patients did not experience cancer recurrence in the treated area.

Most patients tolerate HDR brachytherapy well, with side effects that are usually manageable. Long-term follow-ups have demonstrated this treatment's effectiveness and reliability. While some side effects may occur, they often resemble those experienced with other types of radiation therapy, such as tiredness or urinary problems.

Overall, HDR brachytherapy is a promising option for treating prostate cancer, with strong evidence supporting its safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about HDR partial prostate brachytherapy because it offers a targeted approach to treating recurrent prostate cancer. Unlike traditional treatments such as surgery, external beam radiation therapy, or hormone therapy, this method delivers high doses of radiation directly to the cancerous site with precision, minimizing damage to surrounding healthy tissue. This precision not only aims to improve the effectiveness of the treatment but also reduces potential side effects, making it a promising option for better quality of life during and after treatment.

What evidence suggests that HDR Brachytherapy is effective for prostate cancer?

Research shows that HDR (High Dose Rate) partial prostate brachytherapy, which participants in this trial will receive, effectively treats prostate cancer. Studies have found that HDR brachytherapy controls the disease well in men with localized prostate cancer. Long-term results demonstrate that this treatment is particularly effective when combined with external beam radiotherapy. One study found that 97% of patients did not experience cancer recurrence in the treated area. Additionally, HDR brachytherapy requires fewer treatment sessions, reducing travel for patients. Overall, HDR brachytherapy is promising for managing prostate cancer, with strong evidence supporting its use. ^{1 2 3 4 6}

Who Is on the Research Team?

Mira Keyes, MD

Principal Investigator

BCCA

Are You a Good Fit for This Trial?

Men over 45 with a life expectancy of more than 10 years, who have had prostate cancer return after external beam radiotherapy. They should not have severe late side effects from previous treatments, must be able to undergo advanced MRI scans, and have confirmed localized recurrence suitable for high dose brachytherapy. Patients with inflammatory bowel disease or prior rectal surgery can't join.

Inclusion Criteria

I have not experienced severe side effects from previous radiation therapy.

INR <2.5 and platelet count >75 x 109/L

Rising PSA post EBRT > nadir + 2 ng/ml but < 10 ng/ml

Exclusion Criteria

I am unable to understand and agree to the study's procedures and risks.

Not compliant with criteria above

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Two fractions of high dose rate prostate brachytherapy delivered 2 weeks apart

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for toxicity, quality of life, and efficacy using PSA and mpMRI

24 months

Regular visits for monitoring

Long-term follow-up

Monitoring of late quality of life and adverse events up to 60 months

60 months

What Are the Treatments Tested in This Trial?

Interventions

• HDR partial prostate brachytherapy

Trial Overview The trial is testing High Dose Rate (HDR) partial prostate brachytherapy on patients whose prostate cancer has returned post-radiotherapy. It focuses on the area identified by mpMRI as having recurrent cancer, aiming to see if targeted HDR brachytherapy can effectively treat these local recurrences.

How Is the Trial Designed?

Group I: HDR partial prostate brachytherapy Experimental Treatment 1 Intervention

2 fractions of high dose rate prostate brachytherapy will be delivered to the site of recurrent disease as determined by mp-MRI

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

Approved in European Union as High Dose Rate Brachytherapy for:

• Prostate cancer
• Local recurrence of prostate cancer after external beam radiotherapy

Approved in United States as HDR Brachytherapy for:

• Prostate cancer
• Local recurrence of prostate cancer after external beam radiotherapy

Approved in Canada as High Dose Rate Brachytherapy for:

• Prostate cancer
• Local recurrence of prostate cancer after external beam radiotherapy

Who Is Running the Clinical Trial?

British Columbia Cancer Agency

Lead Sponsor

Trials

181

Recruited

95,900+

Published Research Related to This Trial

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]

Prostate high dose rate (HDR) brachytherapy can be safely performed in a free-standing cancer center, with only 3.7% of procedures resulting in complications requiring catheter placement.

The treatment is well tolerated, with 20% of patients experiencing significant post-implant dysuria lasting an average of 7.5 days, indicating manageable side effects when combined with external beam radiation and hormonal therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate high dose rate brachytherapy in a free-standing cancer center setting. Tharp, M., Bennett, R., Burns, J., et al.[2016]

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]

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]

Single-fraction high-dose-rate (HDR) brachytherapy is a safe and effective treatment for early-stage prostate cancer, showing a low cumulative incidence of biochemical recurrence (BCR) at 2 years, particularly in low-risk patients (0% BCR).

In a study of 124 men with a median follow-up of 2.2 years, the overall BCR rate was 9.7%, with no prostate cancer-specific mortality and no severe genitourinary toxicity reported, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-fraction brachytherapy as monotherapy for early-stage prostate cancer: The UCSF experience. Xu, MJ., Chen, KS., Chang, AJ., et al.[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]

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]

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]

High-dose-rate (HDR) brachytherapy is an effective and well-tolerated treatment for localized prostate cancer, with a median follow-up of 18 months showing manageable side effects.

The interval between HDR treatment sessions (1 week vs. 2 weeks) does not significantly affect patient-reported quality of life or physician-graded toxicity, indicating flexibility in treatment scheduling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and physician reported toxicity with two-fraction definitive high-dose-rate prostate brachytherapy: the impact of implant interval. Harris, AA., Korpics, M., Sherwani, Z., et al.[2022]

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]

A new therapy protocol combining high dose rate (HDR) brachytherapy and external beam radiation showed promising results in treating localized prostate cancer, with a 76.7% survival rate and 86.3% of patients remaining disease-free over a median follow-up of 6 years.

The study found that factors like lower tumor stage (T1-2), lower grade (G1-2), and normal PSA levels after treatment were associated with longer survival, highlighting the importance of PSA status as an independent prognostic factor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[High dosage brachytherapy and external irradiation of localized prostate carcinoma--results at the Kiel University Clinic]. Kovács, G., Galalae, R., Loch, T., et al.[2018]

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]

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. 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.

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

High-dose-rate brachytherapy boost for prostate cancer: A ... This study reports BPFS of 85.7%, local relapse-free survival of 97%, distant MFS of 97.6% and OS of 77.6%20.

5. 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.

6. prostatecanceruk.org prostatecanceruk.org/prostate-information-and-support/treatments/high-dose-rate-brachytherapy

High dose-rate (HDR) brachytherapy HDR brachytherapy gives an extra dose of radiotherapy to the prostate. You might hear this called a brachytherapy 'boost'. Having both external beam ...