NCT00573833

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Nov 2007

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 14, 2007

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

October 20, 2017

Completed
Last Updated

October 20, 2017

Status Verified

September 1, 2017

Enrollment Period

6.8 years

First QC Date

December 13, 2007

Results QC Date

December 21, 2015

Last Update Submit

September 19, 2017

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostatestage IIB prostate cancerstage IIA prostate cancer

Outcome Measures

Primary Outcomes (2)

  • Number of Patients With an Acceptable Level of Severe Toxicity as Defined at < Grade 3 CTC Toxicity

    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

    At scheduled 3 month intervals for one year

  • Number of Patients With an Acceptable Level of Treatment Related Urinary and Rectal Toxicity as Defined at < Grade 3 CTC Toxicity

    urinary and rectal toxicity-see the adverse event tables

    Within 90 days of treatment (early toxicities) or after 90 days (late toxicities)

Other Outcomes (2)

  • Number of Participants Having an International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 Through 12-Week Endpoint

    week 12 reported

  • Median International Prostate Symptom Total Score

    week 12 reported

Study Arms (1)

HDR Brachytherapy

EXPERIMENTAL

9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days

Other: questionnaire administrationProcedure: quality-of-life assessmentRadiation: brachytherapy

Interventions

questionnaire administrationOTHER
HDR Brachytherapy
quality-of-life assessmentPROCEDURE
HDR Brachytherapy
brachytherapyRADIATION
HDR Brachytherapy

Eligibility Criteria

Age18 Years - 120 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Intermediate-risk adenocarcinoma of the prostate, defined by 1of the following criteria:
  • PSA 10-20 ng/mL
  • Gleason score ≥ 7
  • Stage ≥ T2b AND \< T3
  • Less than 20% risk of seminal vesicle involvement or lymph node involved based upon the Kattan nomogram (pre-treatment risk with IMRT)
  • Prostate size \< 60 cc by MRI or CT imaging
  • International Prostate Symptom Score Index ≤ 15

You may not qualify if:

  • Evidence of definitive extracapsular extension/seminal vesicle invasion or pelvic adenopathy by MRI (endorectal coil) and DRE (digital rectal examination)
  • PSA \> 20 ng/mL
  • Presence of distant metastases
  • PATIENT CHARACTERISTICS:
  • WBC ≥ 3,500/mm³
  • Platelet count ≥ 75,000/mm³
  • Hemoglobin ≥ 10 g/dL
  • Creatinine ≤ 1.5 mg/dL
  • Liver function tests ≤ 1.5 times normal
  • INR ≤ 2.5
  • Able to complete quality of life questionnaires
  • Able to give informed consent
  • No active perineal infections
  • No history of urethral stricture
  • No prior history of pelvic malignancy
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Brachytherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeutics

Results Point of Contact

Title
Dr. Josh Yoshiya Yamada, Assistant Attending
Organization
Memorial Sloan Kettering Cancer Center
yamadaj@mskcc.org
+1212-639-2950

Study Officials

  • Josh Yamada, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

  • Michael J. Zelefsky, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

  • Sherri M. Donat, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

  • Marco Zaider, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2007

First Posted

December 14, 2007

Study Start

November 1, 2007

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

October 20, 2017

Results First Posted

October 20, 2017

Record last verified: 2017-09

Locations

US(1)