HDR Brachytherapy for Prostate Cancer

Overseen By Hans Chung, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Disqualifiers: Castrate resistance, Prior therapies, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Acute period (<6 months)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach called focal salvage HDR brachytherapy for prostate cancer that recurs in the same location after other treatments. The goal is to determine if placing temporary radioactive seeds in the prostate safely and effectively treats the cancer with minimal side effects. Men eligible for this trial are those whose prostate cancer has returned more than 30 months after initial radiation treatment and remains confined to the prostate, as confirmed by specific scans and tests. As an unphased trial, it offers patients the chance to explore innovative treatment options not yet widely available.

Will I have to stop taking my current medications?

The trial information does not specify if 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 this focal salvage HDR brachytherapy is safe for prostate cancer treatment?

Research has shown that Focal Salvage HDR Brachytherapy is generally safe for treating prostate cancer that returns after initial treatment. One study found this method both safe and effective for cancer recurrence in a specific area after radiation. Reports indicate a good safety record, with most patients tolerating it well.

Another study found that three years after treatment, about 86% of patients did not require additional hormone therapy, suggesting manageable side effects for many. While any medical procedure carries risks, this treatment is promising because it targets only the affected part of the prostate, aiming to minimize side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for prostate cancer, such as surgery, external beam radiation, or hormone therapy, focal salvage HDR brachytherapy offers a targeted approach. This treatment is unique because it delivers high doses of radiation directly to the cancerous area within the prostate, minimizing exposure to surrounding healthy tissues. Researchers are excited about this technique because it has the potential to reduce side effects and improve the quality of life for patients by preserving more of the prostate's normal function. Additionally, HDR brachytherapy can be performed in fewer sessions compared to traditional treatments, which is a significant benefit for patient convenience and overall healthcare efficiency.

What evidence suggests that focal salvage HDR brachytherapy is effective for prostate cancer?

Studies have shown that focal salvage HDR (high-dose-rate) brachytherapy, the treatment under study in this trial, can effectively treat prostate cancer that recurs in a specific area. Research indicates that this treatment is generally well tolerated and shows promise in controlling cancer without severe side effects. In one study, about 54.4% of patients had their cancer under control for at least three years after treatment. This method targets only the cancerous areas while sparing healthy prostate tissue, potentially leading to fewer complications compared to other treatments. Overall, focal salvage HDR brachytherapy appears to be a safe and effective option for prostate cancer that returns after initial treatment. ^{1 3 6 7 8}

Who Is on the Research Team?

Hans Chung, MD

Principal Investigator

Sunnybrook Health Sciences Centre, Odette Cancer Centre

Are You a Good Fit for This Trial?

Men with isolated local recurrence of prostate cancer after initial radiation therapy, who have a solitary recurrence confirmed by MRI and biopsy, PSA levels below 10 ng/mL, prostate volume under 50cc, good performance status (ECOG 0-1), no metastases on CT/MRI or bone scan, manageable urinary symptoms (IPSS < 15), and no prior extensive prostate treatments like TURP or chemotherapy.

Inclusion Criteria

My prostate cancer returned over 30 months after finishing treatment.

American Urological Association Symptom Index Score (IPSS) < 15

Baseline serum PSA < 10 ng/mL

Exclusion Criteria

I have undergone treatments like surgery or chemotherapy for prostate cancer.

My prostate cancer is resistant to hormone therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive focal salvage HDR prostate brachytherapy using temporary implantation of radioactive seeds

Acute period (<6 months)

Follow-up

Participants are monitored for acute and late urinary and rectal toxicities, as well as quality of life

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Focal Salvage HDR Brachytherapy

Trial Overview The trial is testing focal salvage HDR brachytherapy—a targeted internal radiation treatment where radioactive seeds are temporarily implanted in the prostate. This pilot study aims to assess how feasible this approach is and what side effects it might cause when treating only the affected part of the prostate.

How Is the Trial Designed?

Group I: Focal salvage HDR prostate brachytherapy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Canadian Association of Radiation Oncology

Industry Sponsor

Trials

8

Recruited

500+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40789422/

Updated results of MR-assisted focal salvage HDR ... Conclusion: Our toxicity and PSA failure-free results suggest that focal gland salvage HDR brachytherapy is well tolerated and effective.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0167814025045955

Updated results of MR-assisted focal salvage HDR ... Our updated analysis of 59 patients undergoing focal salvage HDR brachytherapy showed a 36-month biochemical control rate of 54.4 % with encouragingly low ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11930011/

Long-term outcomes of salvage high-dose-rate ... Salvage HDR-BT without ADT is a safe and effective treatment option for localized prostate cancer recurrence after definitive radiation therapy.

4. thegreenjournal.com thegreenjournal.com/issue/S0167-8140(25)X0003-7?pageStart=6

May 2025 Brachytherapy: Urology · 140 20-year outcomes of Low-Dose-Rate versus High-Dose-Rate brachytherapy boost in prostate cancer: A comparative study.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03312972

Focal Salvage HDR Brachytherapy for Locally Recurrent ... With focal HDR brachytherapy, the investigators can treat the isolated areas of disease, while avoiding normal prostate tissue, with the goal of further ...

6. thegreenjournal.com thegreenjournal.com/article/S0167-8140(23)00033-6/fulltext

Recurrence characteristics after focal salvage HDR ... 3-yrs local recurrence-free survival was 51% after focal salvage HDR brachytherapy. •. 3-yrs local ADT-free survival was 86% after focal salvage ...

7. bjui-journals.onlinelibrary.wiley.com bjui-journals.onlinelibrary.wiley.com/doi/full/10.1111/bju.16150

F‐SHARP: a Phase I/II trial of focal salvage high‐dose‐rate ... Salvage high-dose rate (HDR) brachytherapy offers a promising local therapy option, with encouraging toxicity and efficacy based on early series ...

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

High-Dose-Rate Brachytherapy Boost for Prostate Cancer Overall, this study demonstrated the efficacy of EBRT-boosted brachytherapy in the treatment of intermediate- and high-risk prostate cancer, with MFS rates of ...