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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2.5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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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My urinary symptoms are mild based on a score I completed.
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I have not received any hormone therapy.
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I can carry out all my usual activities without help.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Biochemical prostate specific antigen (PSA) progression
Side effects data
From 2021 Phase 3 trial • 926 Patients • NCT0141460879%
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
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
~2100
Questionnaire
2014
Completed Phase 2
~20090
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,149 Total Patients Enrolled
95 Trials studying Prostate Cancer
29,440 Patients Enrolled for Prostate Cancer
Steven J. Frank, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
440 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My prostate is 60 cc or smaller, as measured by ultrasound.My cancer has spread to nearby lymph nodes.My cancer is not in the most advanced stages.I have had major surgery or treatments for prostate cancer.My prostate cancer is in the early stages and hasn't spread to lymph nodes or other parts.My prostate cancer is intermediate risk with specific PSA and Gleason scores.I am 18 years old or older.I have an active prostate infection.My urinary symptoms are mild based on a score I completed.I have not received any hormone therapy.My cancer has spread to distant parts of my body.I can carry out all my usual activities without help.
Research Study Groups:
This trial has the following groups:- Group 1: Brachytherapy - Participants with < 35% biopsy core
- Group 2: Brachytherapy - Participants with > 35% biopsy core
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What level of risk is associated with Brachytherapy treatments?
"The safety of brachytherapy was given a rating of 2 on our scale, as it is currently undergoing Phase 2 clinical trials which provide evidence in support of its security but lack data to confirm efficacy."
Answered by AI
Are there any openings for participants in this investigation?
"According to clinicaltrials.gov, this trial is not recruiting at present time. It was initially posted on August 1st 2006 and the most recent update occured in September 2021. Nonetheless, there are still over 3700 other studies actively searching for participants."
Answered by AI
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