What side effects are associated with this type of intervention?

The most common treatments for localized prostate cancer include radiation therapy, such as the temporary implantation of radioactive seeds (brachytherapy), external beam radiotherapy, and radical prostatectomy. Known side effects of these treatments can include urinary symptoms (e.g., frequency, urgency, and discomfort), bowel issues (e.g., diarrhea and rectal bleeding), and sexual dysfunction (e.g., erectile dysfunction). Additionally, patients may experience fatigue and, in some cases, localized pain or discomfort at the treatment site. Each treatment has distinct patterns of adverse effects, and the severity can vary based on individual patient factors and the specific treatment modality used.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer that involve localized radiation therapy. One such treatment is low-dose-rate brachytherapy (SEED-BT), where radioactive seeds are permanently implanted into the prostate. Another approved treatment is high-dose-rate brachytherapy, which involves temporarily placing radioactive sources in the prostate. Additionally, radiopharmaceuticals like radium-223 (Ra-223) have been approved for treating metastatic castration-resistant prostate cancer with symptomatic bone metastases. These treatments aim to deliver targeted radiation to cancer cells while minimizing damage to surrounding healthy tissue.

What other types of research exist?

Promising, novel alternatives to temporary implantation of radioactive seeds for prostate cancer patients include: 1) Permanent brachytherapy using iodine-125 seeds, which has shown efficacy in multiple studies. 2) High-frequency ultrasound (HIFU), which uses focused sound waves to target and destroy cancer cells. 3) Cryotherapy, which involves freezing cancer cells to kill them. 4) Focal salvage HDR brachytherapy, which targets only the affected areas of the prostate, potentially reducing side effects. Patients should discuss these options with their doctor to determine the best treatment plan based on their specific condition.

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Brachytherapy

HDR Brachytherapy for Prostate Cancer

Q: What is the mechanism of action of this treatment?

Localized radiation therapy, such as the temporary implantation of radioactive seeds (brachytherapy), works by placing radioactive material directly into the prostate. These seeds emit radiation over time, targeting and killing cancer cells while sparing surrounding healthy tissue. This precision reduces side effects compared to external beam radiation. For prostate cancer patients, this means an effective treatment option with potentially fewer complications and a focus on preserving quality of life.

N/A

Waitlist Available

Led By Hans Chung, MD

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Staging CT or MRI (abdomen and pelvis) and bone scan negative for metastases

ECOG performance status 0-1

Must not have

Evidence of castrate resistance (defined as PSA > 3 ng/mL while testosterone is < 1.7 nmol/L)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a treatment where small radioactive seeds are temporarily placed inside the prostate to kill cancer cells. It targets patients whose prostate cancer has come back but hasn't spread. The goal is to see if this focused treatment can reduce side effects compared to treating the whole prostate.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include urinary issues due to irritation from the radioactive seeds, bowel problems if nearby tissues are affected by radiation, sexual dysfunction as a result of nerve damage near the treated area, and general discomfort associated with invasive procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My scans show no cancer spread to my abdomen, pelvis, or bones.

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I am fully active or can carry out light work.

Select...

My prostate is smaller than 50cc.

Select...

My MRI shows a single cancer recurrence in my prostate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My prostate cancer is resistant to hormone therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of acute urinary and rectal toxicities

Secondary study objectives

Acute and late urinary toxicities

Incidence of late urinary and rectal toxicities

Quality of Life (QoL)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Focal salvage HDR prostate brachytherapyExperimental Treatment1 Intervention

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Localized radiation therapy, such as the temporary implantation of radioactive seeds (brachytherapy), works by placing radioactive material directly into the prostate. These seeds emit radiation over time, targeting and killing cancer cells while sparing surrounding healthy tissue. This precision reduces side effects compared to external beam radiation. For prostate cancer patients, this means an effective treatment option with potentially fewer complications and a focus on preserving quality of life.

Prostate Leiomyosarcoma: A Rare Misleading Tumor.Hormonal therapy in the management of prostate cancer: from Huggins to the present.