Your session is about to expire
← Back to Search
Radiation Therapy
brachytherapy for Prostate Cancer
Phase 2
Waitlist Available
Led By Marisa Kollmeier, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial is testing a new, more intense form of radiation therapy to see if it is safe and effective.
Eligible Conditions
- Prostate Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Urinary Toxicity Assessed by CTCAE v4.0
Secondary outcome measures
Mean Change in International Prostate Symptom Score (IPSS) to Assess Urinary Functioning From Baseline at 12 Months
Side effects data
From 2019 Phase 3 trial • 224 Patients • NCT0010717218%
Dyspnea
7%
Pneumonia
5%
Hypoxia
5%
Thrombosis
3%
Postoperative hemorrhage
3%
Acidosis
3%
Respiratory disorder
2%
Urinary tract infection
2%
Adult respiratory distress syndrome
2%
Myocardial ischemia
2%
Serum sodium decreased
2%
Chest wall pain
2%
Postoperative thoracic procedure complication
1%
Colitis
1%
Pain
1%
Confusion
1%
Cardiac disorder
1%
Chest pain
1%
Cardiopulmonary arrest
1%
Bronchospasm
1%
Cognitive disturbance
1%
Ischemia cerebrovascular
1%
Infection
1%
Decubitus ulcer
1%
Lymphocyte count decreased
1%
Dehydration
1%
Aspiration
1%
Ascites
1%
Pleural effusion
1%
Ventricular arrhythmia
1%
Dizziness
1%
Vision blurred
1%
Fatigue
1%
Intracranial hemorrhage
1%
Peripheral motor neuropathy
1%
Ileus
1%
Nausea
1%
Vomiting
1%
Alanine aminotransferase increased
1%
Anorexia
1%
Pneumothorax
1%
Creatinine increased
1%
Treatment related secondary malignancy
1%
Hypertension
1%
Hypotension
1%
Peripheral ischemia
1%
Atrial fibrillation
1%
Cardiac pain
1%
Intraoperative neurological injury - NERVES: Recurrent laryngeal
1%
Muscle weakness
1%
Musculoskeletal disorder
1%
Trigeminal nerve disorder
1%
Glomerular filtration rate decreased
1%
Pneumonitis
1%
Back pain
1%
Pain in extremity
1%
ADH abnormal
1%
Prolonged intubation after pulmonary resection (>24 hrs after surgery)
1%
Abdominal infection
1%
Depressed level of consciousness
1%
Enteritis
1%
Renal failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A (SR)
Arm B (SR + BX)
Trial Design
1Treatment groups
Experimental Treatment
Group I: radiation therapy in combination with brachytherapyExperimental Treatment3 Interventions
Patients will undergo low dose rate (LDR) prostate brachytherapy using Pd-103 followed approximately 4 weeks later with hypofractionated image-guided external beam radiation therapy (25Gy in 5 fractions; 5Gy x 5 fractions every other day) to the prostate & seminal vesicles. Both brachytherapy as well as external beam will be performed according to our current standards of practice using the same equipment, techniques, & treatment planning procedures. Pts will be followed post-treatment at 1, 3, 6 (+/- 4 weeks) & every 6 months (+/- 4 weeks) thereafter until 36 months. During the post-treatment followup, pts will be evaluated for urinary, bowel/rectal & sexual toxicity. Baseline measures of these domains will be obtained prior to treatment at the time of enrollment. Serum PSA levels will be drawn on the same schedule as clinical followup. Post-treatment prostate biopsies will be obtained once between 24-36 months post-treatment to evaluate pathologic response to therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
external beam radiation therapy
2013
Completed Phase 2
~440
questionnaires
2008
Completed Phase 2
~3450
brachytherapy
2008
Completed Phase 3
~7210
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,934 Previous Clinical Trials
588,765 Total Patients Enrolled
132 Trials studying Prostate Cancer
52,029 Patients Enrolled for Prostate Cancer
Marisa Kollmeier, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
19 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are patients still being recruited for this clinical trial?
"It seems that this particular clinical trial is not currently looking for new patients, as the last update was on November 1st, 2022. However, there are 1366 other trials with more recent postings."
Answered by AI
Are there short-term risks associated with brachytherapy?
"Since this is a Phase 2 trial, meaning that while there are some data supporting safety, there are no data yet to support efficacy, our team has estimated the safety of brachytherapy to be a 2."
Answered by AI
How many medical clinics are conducting this study?
"There are 6 enrolling patients for this clinical trial at locations such as Memorial Sloan Kettering at Basking Ridge in Basking Ridge, Memorial Sloan Kettering Cancer Center @ Suffolk in Commack, and Memorial Sloan Kettering Nassau (Follow Up Only) in Uniondale."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger