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Brachytherapy

Brachytherapy for Prostate Cancer

Phase 2
Waitlist Available
Led By Steven J. Frank, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prostate volumes by TRUS less than or equal to 60 cc.
Histologically confirmed adenocarcinoma of the prostate, clinical stage T1c - T2b (AJCC 6th Edition), N0, M0. Lymph node evaluation by either CT or MRI.
Must not have
Lymph node involvement (N1).
Stage < T1c, T2c, T3 or T4 disease (AJCC 6th Edition).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will study whether prostate brachytherapy is an effective treatment for intermediate risk prostate cancer, as well as the safety of the procedure.

Who is the study for?
This trial is for men over 18 with intermediate risk prostate cancer, no distant metastases, and a good performance status. They must have a prostate volume ≤60 cc by ultrasound, low urinary symptoms, and specific PSA levels. Prior treatments like surgery or radiation for prostate cancer disqualify them.
What is being tested?
The study tests brachytherapy's effectiveness in controlling intermediate risk prostate cancer. It involves implanting radioactive seeds into the prostate to deliver targeted radiation therapy. Participants' safety and responses are monitored through questionnaires.
What are the potential side effects?
Possible side effects of brachytherapy may include discomfort during seed placement, urinary issues such as frequency or urgency, bowel changes, erectile dysfunction, and localized pain or swelling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate is 60 cc or smaller, as measured by ultrasound.
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My prostate cancer is in the early stages and hasn't spread to lymph nodes or other parts.
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I am 18 years old or older.
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My prostate cancer is intermediate risk with specific PSA and Gleason scores.
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I can carry out all my usual activities without help.

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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My cancer is not in the most advanced stages.
Select...
I have had major surgery or treatments for prostate cancer.
Select...
I have an active prostate infection.
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My cancer has spread to distant parts of my body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2021 Phase 3 trial • 926 Patients • NCT01414608
79%
Fatigue
76%
Nausea
73%
Diarrhea
71%
Lymphocyte count decreased
65%
Anemia
36%
Vomiting
35%
Abdominal pain
31%
Vaginal discharge
31%
Platelet count decreased
28%
Pelvic pain
26%
Neutrophil count decreased
24%
Peripheral sensory neuropathy
22%
General disorders NOS
20%
Cystitis noninfective
17%
Alanine aminotransferase increased
16%
Pain in extremity
14%
Dermatitis radiation
12%
Creatinine increased
12%
Dehydration
11%
Vaginal pain
10%
Myalgia
10%
Hemorrhage Bladder
9%
Aspartate aminotransferase increased
9%
Hearing impaired
8%
Proctitis
8%
Vaginal dryness
8%
Alopecia
7%
Hemorrhage Rectum
7%
Vaginal stricture
6%
Mucositis oral
6%
Thrombosis/Thrombus/Embolism
6%
Urinary tract pain
4%
Allergic reaction/ hypersensitivity
4%
Rectal pain
3%
Anal pain
3%
Colitis
3%
Lymphedema
2%
Perineal pain
2%
Telangiectasia
2%
Enterocolitis
2%
Febrile neutropenia
2%
Female genital tract fistula
2%
Peripheral motor neuropathy
2%
Tumour pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard Chemoradiation
Standard Chemoradiation With Adjuvant Chemotherapy

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
Group I: Brachytherapy - Participants with > 35% biopsy coreExperimental Treatment2 Interventions
Brachytherapy implant procedure lasting 1-2 hours. Questionnaires taking 30 total minutes.
Group II: Brachytherapy - Participants with < 35% biopsy coreExperimental Treatment2 Interventions
Brachytherapy implant procedure lasting 1-2 hours. Questionnaires taking 30 total minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brachytherapy
2007
Completed Phase 3
~2140
Questionnaire
2014
Completed Phase 2
~19970

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,047 Total Patients Enrolled
87 Trials studying Prostate Cancer
28,328 Patients Enrolled for Prostate Cancer
Steven J. Frank, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
440 Total Patients Enrolled

Media Library

Brachytherapy (Brachytherapy) Clinical Trial Eligibility Overview. Trial Name: NCT00525720 — Phase 2
Prostate Cancer Research Study Groups: Brachytherapy - Participants with < 35% biopsy core, Brachytherapy - Participants with > 35% biopsy core
Prostate Cancer Clinical Trial 2023: Brachytherapy Highlights & Side Effects. Trial Name: NCT00525720 — Phase 2
Brachytherapy (Brachytherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00525720 — Phase 2
~26 spots leftby Sep 2026
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