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Brachytherapy

HDR vs LDR Brachytherapy for Prostate Cancer (LDR/HDRmono Trial)

N/A

Recruiting

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

Favorable risk and low-tier intermediate-risk prostate cancer with estimated life expectancy of at least 10 years.

Extensive favorable-risk disease is defined as: clinical stage T1c-T2a PSA < 10 Gleason 6 ≥ 50% of biopsy cores containing cancer PSA density > 0.2 ng/cc

Must not have

Prior pelvic radiation

Prior TURP or cryosurgery of the prostate

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5-10 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing two types of prostate cancer treatments to see which is more effective.

Who is the study for?

Men with favorable to intermediate-risk prostate cancer, who have a life expectancy of at least 10 years and are not candidates for active surveillance. They should have no prior radical prostate surgeries or treatments like TURP, cryosurgery, pelvic radiation, or chemotherapy for prostate cancer. Their PSA levels and Gleason scores must meet specific criteria.

What is being tested?

This trial compares two types of internal radiation therapy for treating prostate cancer: high dose rate (HDR) vs. low dose rate (LDR) brachytherapy. It's designed to see which method is more effective in patients with certain risk levels of prostate cancer.

What are the potential side effects?

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

Eligibility Criteria

Inclusion Criteria

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

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My prostate cancer is at an early or intermediate stage, and I am expected to live 10 more years.

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My prostate cancer is at an early stage, with specific test results.

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My prostate cancer is at an early stage, with low PSA and Gleason scores, and I'm mostly active.

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 surgery or cryotherapy for prostate issues before.

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I have had major surgery for prostate cancer.

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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.

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 anesthesia, 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 anesthesia 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