NCT00684905

Brief Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide and bicalutamide, may lessen the amount of androgens made by the body. Implant radiation therapy kills tumor cells by placing material such as radioactive iodine directly into or near a tumor. Giving leuprolide and bicalutamide together with implant radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects of giving leuprolide and bicalutamide together with implant radiation therapy and to see how well it works in treating patients with locally recurrent prostate cancer after external-beam radiation therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Timeline
Completed

Started Apr 2000

Typical duration for phase_2 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

April 1, 2000

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 28, 2008

Completed
Last Updated

November 12, 2012

Status Verified

November 1, 2012

Enrollment Period

5.5 years

First QC Date

May 14, 2008

Last Update Submit

November 9, 2012

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostaterecurrent prostate cancerstage I prostate cancerstage II prostate cancerstage III prostate cancer

Outcome Measures

Primary Outcomes (4)

  • Feasibility

  • Patient tolerance

  • Toxicities

  • Tumor response

Interventions

bicalutamideDRUG
leuprolide acetateDRUG
adjuvant therapyPROCEDURE
neoadjuvant therapyPROCEDURE
quality-of-life assessmentPROCEDURE
brachytherapyRADIATION

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Biopsy-proven adenocarcinoma of the prostate * Locally recurrent disease, defined by digital rectal examination and/or rising prostate-specific antigen (PSA) * No evidence of nodal or distant metastasis (i.e., N0, M0) on physical examination, bone scan, or CT scan of the pelvis * Clinical stage T1c-T3a disease at the time of recurrence * PSA \< 10 ng/mL * Prostate volume by transrectal ultrasonography \< 60 cc * Received prior external beam radiotherapy PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * WBC ≥ 3,000/μL * Platelet count ≥ 90,000/μL * Hemoglobin ≥ 10 g/dL * Alkaline phosphatase \< 2 times normal * AST \< 2 times normal * Normal prothrombin time and partial thromboplastin time * No significant obstructive urinary symptoms (AUA score ≤ 16) * No contraindication for general anesthesia PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior transurethral resection of the prostate

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

bicalutamideLeuprolideChemotherapy, AdjuvantNeoadjuvant TherapyBrachytherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsCombined Modality TherapyTherapeuticsDrug TherapyRadiotherapy

Study Officials

  • William W. Wong, MD

    Mayo Clinic

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 14, 2008

First Posted

May 28, 2008

Study Start

April 1, 2000

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

November 12, 2012

Record last verified: 2012-11

Locations

US(1)