NCT00525720

Brief Summary

The goal of this clinical research study is to learn if a prostate implant (brachytherapy) can help to control intermediate risk prostate cancer. The safety of this procedure will also be studied. Prostate brachytherapy is performed by inserting permanent seeds (which are radioactive pellets) into your prostate in order to treat the prostate cancer with radiation therapy.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_2 prostate-cancer

Timeline
17mo left

Started Aug 2006

Longer than P75 for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress93%
Aug 2006Sep 2027

Study Start

First participant enrolled

August 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 6, 2007

Completed
19.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

20.2 years

First QC Date

September 4, 2007

Last Update Submit

March 5, 2026

Conditions

Prostate Cancer

Keywords

Prostate CancerProstatic CarcinomaIntermediate prostate cancerTransperineal Interstitial Permanent BrachytherapyBrachytherapyProstate brachytherapyProstate implantProstateQuestionnaireSurvey

Outcome Measures

Primary Outcomes (1)

  • Biochemical prostate specific antigen (PSA) progression

    2.5 Years

Study Arms (2)

Brachytherapy - Participants with < 35% biopsy core

EXPERIMENTAL

Brachytherapy implant procedure lasting 1-2 hours. Questionnaires taking 30 total minutes.

Drug: BrachytherapyBehavioral: Questionnaire

Brachytherapy - Participants with > 35% biopsy core

EXPERIMENTAL

Brachytherapy implant procedure lasting 1-2 hours. Questionnaires taking 30 total minutes.

Drug: BrachytherapyBehavioral: Questionnaire

Interventions

BrachytherapyDRUG

Brachytherapy implant procedure lasting 1-2 hours.

Brachytherapy - Participants with < 35% biopsy coreBrachytherapy - Participants with > 35% biopsy core
QuestionnaireBEHAVIORAL

Questionnaires taking 30 total minutes.

Also known as: Survey
Brachytherapy - Participants with < 35% biopsy coreBrachytherapy - Participants with > 35% biopsy core

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed adenocarcinoma of the prostate, clinical stage T1c - T2b (AJCC 6th Edition), N0, M0. Lymph node evaluation by either CT or MRI.
  • Zubrod performance status 0-1.
  • Patient must be greater than or equal to 18 years of age.
  • Patients with intermediate risk prostate cancer as determined by one of the following combinations: Gleason \< 7, PSA 10-15; Gleason 7, PSA must be \< 10.
  • Prostate specific antigen (PSA) prior to study entry must be less than or equal to 15 ng/ml.
  • Hormone naive.
  • Prostate volumes by TRUS less than or equal to 60 cc.
  • AUA voiding symptom scores \</= 15 (alpha blockers allowed); this is completed by the patient.
  • Patients must sign a study-specific informed consent form prior to study entry.

You may not qualify if:

  • Stage \< T1c, T2c, T3 or T4 disease (AJCC 6th Edition).
  • Lymph node involvement (N1).
  • Evidence of distant metastases (M1).
  • Radical surgery for carcinoma of the prostate, prior pelvic radiation, prior chemotherapy for prostate cancer, prior TURP, prior cryosurgery, TUNA, TUMT of the prostate.
  • Active prostatitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

BrachytherapySurveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Steven J. Frank, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2007

First Posted

September 6, 2007

Study Start

August 1, 2006

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2027

Last Updated

March 9, 2026

Record last verified: 2026-03

Locations

US(1)