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Brachytherapy

HDR Brachytherapy for Prostate Cancer

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

ECOG performance status 0-1

Staging T2-weighted, DWI- and DCE- MRI that demonstrates recurrence confined to prostate, and correlates with stereotactic transperineal biopsy

Must not have

Disease adjacent to the urethra as visible on MRI

Any of the following prior therapies; TURP, radionuclide prostate brachytherapy, prostatectomy or prostatic cryosurgery, HIFU, bilateral orchiectomy, chemotherapy for prostatic carcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at the feasibility and toxicity of using radioactive seeds to treat localized prostate cancer that has come back (recurred). There are other options to treat this, but there is no consensus on which is the best. This study will look at whether the radioactive seed treatment is safe and effective.

Who is the study for?

Men with prostate cancer that has come back after radiation therapy, but hasn't spread outside the prostate. They should have a PSA level under 10ng/mL, a prostate size less than 50cc on ultrasound, and be in good physical shape (ECOG status 0-1). Men who've had certain other treatments or surgeries for prostate cancer or show signs of hormone-resistant cancer can't join.

What is being tested?

This study is testing whole gland salvage HDR brachytherapy—a type of internal radiation where radioactive seeds are temporarily placed inside the prostate—to see if it's feasible and safe for treating localized recurrent prostate cancer.

What are the potential side effects?

Potential side effects include urinary issues due to inflammation from the radioactive seeds, bowel problems, erectile dysfunction, and general discomfort at the seed implantation site.

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 MRI shows my prostate cancer has returned but is only in the prostate.

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I have had radiation therapy for prostate cancer with specific dose ranges.

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

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My prostate is smaller than 50cc in volume.

Exclusion Criteria

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

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My MRI shows my condition is near the urethra.

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

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

Acute GI toxicities

Acute GU toxicities

Secondary study objectives

Acute GU symptoms

Biochemical disease free survival

Late GI toxicities

+3 more

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: HDR whole gland salvage treatmentExperimental Treatment1 Intervention

Locally recurrent prostate cancer Whole gland HDR brachytherapy administered Whole gland dose=10.5Gy x 2 fractions delivered one week apart GTV dose=13.5Gy x 2 fractions delivered one week apart

0 / 7Eligibility criteria met