Brachytherapy for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Prostate Cancer+2 More
Brachytherapy - Drug
Eligibility
18+
Male
What conditions do you have?
Select

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.

Eligible Conditions
  • Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 2.5 Years

2.5 Years
Biochemical prostate specific antigen (PSA) progression

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Standard Chemoradiation
79%Fatigue
76%Nausea
73%Diarrhea
71%Lymphocyte count decreased
65%Anemia
36%Vomiting
35%Abdominal pain
31%Platelet count decreased
31%Vaginal discharge
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%Dehydration
12%Creatinine increased
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%Urinary tract pain
6%Thrombosis/Thrombus/Embolism
6%Mucositis oral
4%Rectal pain
4%Allergic reaction/ hypersensitivity
3%Anal pain
3%Lymphedema
3%Colitis
2%Perineal pain
2%Enterocolitis
2%Female genital tract fistula
2%Febrile neutropenia
2%Telangiectasia
2%Tumour pain
2%Peripheral motor neuropathy
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT01414608) in the Standard Chemoradiation ARM group. Side effects include: Fatigue with 79%, Nausea with 76%, Diarrhea with 73%, Lymphocyte count decreased with 71%, Anemia with 65%.

Trial Design

2 Treatment Groups

Brachytherapy - Participants with > 35% biopsy core
1 of 2
Brachytherapy - Participants with < 35% biopsy core
1 of 2
Experimental Treatment

300 Total Participants · 2 Treatment Groups

Primary Treatment: Brachytherapy · No Placebo Group · Phase 2

Brachytherapy - Participants with > 35% biopsy coreExperimental Group · 2 Interventions: Brachytherapy, Questionnaire · Intervention Types: Drug, Behavioral
Brachytherapy - Participants with < 35% biopsy coreExperimental Group · 2 Interventions: Brachytherapy, Questionnaire · Intervention Types: Drug, Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brachytherapy
2007
Completed Phase 3
~2030
Questionnaire
2014
Completed Phase 2
~20100

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2.5 years

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,779 Previous Clinical Trials
1,784,463 Total Patients Enrolled
89 Trials studying Prostate Cancer
27,235 Patients Enrolled for Prostate Cancer
Steven J. Frank, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
442 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Male Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a patient greater than or equal to 18 years of age.
You have a PSA level of less than or equal to 15 ng/ml.
Prostate volumes by TRUS less than or equal to 60 cc.
You have a bladder symptom score of 15 or greater.
You must sign a study-specific informed consent form prior to study entry.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 20th, 2021

Last Reviewed: October 26th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.