What side effects are associated with this type of intervention?

Low Dose Rate (LDR) Brachytherapy, which involves the permanent implantation of radioactive seeds, commonly results in urinary symptoms such as urgency, frequency, and incontinence. Bowel symptoms like urgency and frequency are also reported, though less commonly. Sexual dysfunction is another potential side effect, with some patients experiencing erectile difficulties. High Dose Rate (HDR) Brachytherapy, which involves temporary brachytherapy, shares similar side effects, including urinary and bowel symptoms, as well as sexual dysfunction. Both treatments aim to minimize damage to surrounding tissues, but patients may still experience these side effects to varying degrees.

What prior FDA approvals exist?

The FDA has approved various treatments for prostate cancer, including brachytherapy techniques such as Low Dose Rate (LDR) brachytherapy, which involves the permanent implantation of radioactive seeds, and High Dose Rate (HDR) brachytherapy, which uses temporary radioactive sources. These treatments are designed to deliver targeted radiation to the prostate, minimizing damage to surrounding tissues. Additionally, other FDA-approved treatments for prostate cancer include androgen deprivation therapy (ADT), external beam radiation therapy (EBRT), and chemotherapeutic agents like docetaxel. These therapies aim to manage and control the progression of prostate cancer, offering patients multiple options depending on the stage and aggressiveness of their disease.

What other types of research exist?

Promising novel alternatives to LDR and HDR brachytherapy for prostate cancer patients include Intensity-Modulated Radiation Therapy (IMRT) and Stereotactic Body Radiotherapy (SBRT). IMRT offers precise targeting of the tumor with reduced toxicity to surrounding tissues, while SBRT provides high doses of radiation in fewer sessions, potentially improving convenience and outcomes. Additionally, systemic therapies such as androgen deprivation therapy (ADT) combined with novel agents like abiraterone or enzalutamide are being explored for their efficacy in managing prostate cancer.

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Brachytherapy

HDR vs. LDR Brachytherapy for Prostate Cancer

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

LDR brachytherapy involves permanently implanting radioactive seeds in the prostate, which emit radiation over time to kill cancer cells. HDR brachytherapy uses a temporary radioactive source inserted through catheters, delivering a high dose of radiation in a short period before removal. Both treatments aim to maximize radiation to the tumor while minimizing damage to surrounding tissues. Understanding these mechanisms helps patients make informed decisions about their treatment options and potential side effects.

Phase 3

Waitlist Available

Research Sponsored by British Columbia Cancer Agency

Eligibility Criteria Checklist

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

Must have

ECOG 0-1

Clinical stage T1c-T2b, PSA < 20, Gleason < 8

Must not have

Prior pelvic radiation

Prior radical surgery for carcinoma of the prostate,

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5-10 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial compares two types of internal radiation treatments for men with intermediate risk prostate cancer. One method uses slow-releasing radioactive seeds, while the other delivers a quick, high-intensity dose. The goal is to see if the quicker method leads to faster recovery and fewer side effects.

Who is the study for?

Men with intermediate risk prostate cancer who haven't had pelvic radiation, prostate surgery, chemotherapy for prostate cancer, or certain other prostate treatments. They should have a clinical stage T1c-T2b, PSA < 20 ng/ml, Gleason score < 8, and be in good physical condition (ECOG 0-1). Their tumor characteristics must meet specific criteria and they can't be eligible for just monitoring the cancer without treatment.

What is being tested?

The trial is comparing two types of internal radiation therapy: Low Dose Rate (LDR) brachytherapy involving permanent radioactive seeds and High Dose Rate (HDR) temporary brachytherapy. Participants will be randomly assigned to one of these treatments to see which is more effective at treating intermediate risk prostate cancer.

What are the potential side effects?

Possible side effects from both LDR and HDR brachytherapy may include discomfort or pain during the procedure, urinary issues like frequency or urgency, bowel changes such as diarrhea or rectal bleeding, erectile dysfunction, and fatigue.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or can carry out light work.

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My prostate cancer is in an early stage, with low PSA and Gleason scores.

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My prostate cancer is early stage, with specific PSA and Gleason scores.

Exclusion Criteria

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

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I have had radiation therapy to my pelvic area before.

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I have had major surgery for prostate cancer.

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I have had surgery or cryotherapy for prostate issues.

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I have had chemotherapy for prostate cancer before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5-10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5-10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5-10 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

The difference in Quality of Life in the urinary domain between LDR and HDR brachytherapy.

Secondary study objectives

Acute and long term toxicity

Biochemical Outcome

Cell cycle progression score

+4 more

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: High dose rate brachytherapyExperimental Treatment1 Intervention

Device: Radiation High dose rate prostate brachytherapy is delivered in 2 procedures, 2 weeks apart, also under anaesthesia, but no follow-up imaging visit is required. HDR brachytherapy is also accomplished as an out-patient.

Group II: Low dose rate brachytherapyActive Control1 Intervention

Device: Radiation Low dose rate prostate brachytherapy is delivered under anaesthesia in a single 1.5-2 hour procedure as an out-patient. The men return 4 weeks later for detailed imaging to assess implant quality.

0 / 7Eligibility 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

LDR brachytherapy involves permanently implanting radioactive seeds in the prostate, which emit radiation over time to kill cancer cells. HDR brachytherapy uses a temporary radioactive source inserted through catheters, delivering a high dose of radiation in a short period before removal. Both treatments aim to maximize radiation to the tumor while minimizing damage to surrounding tissues. Understanding these mechanisms helps patients make informed decisions about their treatment options and potential side effects.