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Brachytherapy

Seed Implants for Prostate Cancer

Phase 4
Waitlist Available
Led By Brian J Moran, MD
Research Sponsored by Prostate Cancer Foundation of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
I-PSS score < 25 (alpha blockers allowed)
Low and Low-Intermediate Risk prostate cancer
Must not have
Lymph node involvement (N1)
Radical surgery for carcinoma of the prostate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will compare two types of prostate cancer treatment in terms of patient quality of life.

Who is the study for?
Men over 40 with early-stage prostate cancer (T1c-T2b, N0, M0), no major medical or psychiatric illnesses, and a prostate size ≤ 60 cc. They must not have had previous treatments like hormone therapy or pelvic radiation, no hip replacements, and be able to consent to the study.
What is being tested?
The trial is comparing two types of radioactive seed implants for prostate brachytherapy: ThinStrand with thinner needles versus RapidStrand with standard needles. Quality of life post-treatment will be assessed using the EPIC questionnaire at set intervals.
What are the potential side effects?
Possible side effects include urinary problems, bowel issues, and sexual dysfunction related to the implantation procedure or radioactivity from the seeds affecting nearby tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate symptoms are mild to moderate.
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My prostate cancer is classified as low or low-intermediate risk.
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My prostate cancer is in the early stages and hasn't spread.
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I am 40 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has spread to nearby lymph nodes.
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I have had major surgery for prostate cancer.
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I have had radiation therapy to my pelvic area before.
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I have had surgery for an enlarged prostate.
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I have received hormone therapy before.
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I have had a prostate surgery known as TURP.
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My cancer has spread to distant parts of my body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Health related quality of life including urinary, bowel and sexual function as measured by the EPIC questionnaire

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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
Active Control
Group I: 20 g needleActive Control2 Interventions
Thin Strand
Group II: Iodine-125 standard 18 g needleActive Control2 Interventions
Rapidstrand

Find a Location

Who is running the clinical trial?

Prostate Cancer Foundation of ChicagoLead Sponsor
1 Previous Clinical Trials
1 Trials studying Prostate Cancer
Brian J Moran, MDPrincipal InvestigatorChicago Prostate Center

Media Library

RapidStrand seeds for use with 18g needle (Brachytherapy) Clinical Trial Eligibility Overview. Trial Name: NCT01379742 — Phase 4
Prostate Cancer Research Study Groups: 20 g needle, Iodine-125 standard 18 g needle
Prostate Cancer Clinical Trial 2023: RapidStrand seeds for use with 18g needle Highlights & Side Effects. Trial Name: NCT01379742 — Phase 4
RapidStrand seeds for use with 18g needle (Brachytherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01379742 — Phase 4
~15 spots leftby Dec 2025
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