Internal Radiation Therapy in Treating Patients With Prostate Cancer

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Other: questionnaire administration; Procedure: quality-of-life assessment; Radiation: brachytherapy

• Registration Number: NCT00573833
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells.

PURPOSE: This clinical trial is studying the side effects and how well internal radiation therapy works in treating patients with prostate cancer.

Detailed Description

OBJECTIVES:

Primary

* To assess the feasibility of high-dose rate (HDR) brachytherapy (without the use of external-beam radiotherapy) as definitive treatment for patients with intermediate-risk prostate cancer.

* To assess acceptable toxicity, defined as treatment related toxicity (urinary and rectal), no worse than that seen by patients treated with conventional therapy (grade 3 urinary toxicity \< 10% and grade 3 rectal toxicity \< 10%).

Secondary

* To achieve adequate dosimetric coverage of the prostate comparable to current standards.

* To assess the effect of treatment on sexual function.

OUTLINE: Patients undergo 4 high-dose rate brachytherapy treatments over 2 days.

Patients complete bladder, bowel, sexual function, and quality of life questionnaires, including the International Index of Erectile Function (IIEF) questionnaire, the International Prostate Symptom Score Index (IPSS), and the MSKCC Prostate Quality of Life questionnaire at baseline and then at every follow-up visit.

After completion of study treatment, patients are followed every 3 months for 1 year.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-12-13
• Study First Submitted QC: 2007-12-13
• Study First Posted: 2007-12-14
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Results First Submitted: 2015-12-21
• Status Verified: 2017-09
• Results First Submitted QC: 2017-09-19
• Last Update Submitted: 2017-09-19
• Results First Posted: 2017-10-20
• Last Update Posted: 2017-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 23

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HDR Brachytherapy	quality-of-life assessment	9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days
HDR Brachytherapy	questionnaire administration	9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days
HDR Brachytherapy	brachytherapy	9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days

Primary Outcome Measures

Name	Time	Method
Number of Patients With an Acceptable Level of Severe Toxicity as Defined at < Grade 3 CTC Toxicity	At scheduled 3 month intervals for one year	Feasibility will be defined as an acceptable level of severe toxicity (both acute and late effects), and adequate dosimetric coverage. Severe toxicity will be defined as \> or = grade 3 NCI CTC toxicity
Number of Patients With an Acceptable Level of Treatment Related Urinary and Rectal Toxicity as Defined at < Grade 3 CTC Toxicity	Within 90 days of treatment (early toxicities) or after 90 days (late toxicities)	urinary and rectal toxicity-see the adverse event tables

Trial Locations

Locations (1)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States