NCT00003124

Brief Summary

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using leuprolide and flutamide may fight prostate cancer by reducing the production of androgens. Combining radiation therapy with hormone therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of hormone therapy plus radiation therapy 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
105

participants targeted

Target at P75+ for phase_2 prostate-cancer

Timeline
Completed

Started May 1997

Longer than P75 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

May 1, 1997

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.5 years until next milestone

First Posted

Study publicly available on registry

April 18, 2003

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

January 6, 2014

Status Verified

December 1, 2002

First QC Date

November 1, 1999

Last Update Submit

January 3, 2014

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostatestage I prostate cancerstage IIB prostate cancerstage IIA prostate cancerstage III prostate cancer

Interventions

flutamideDRUG
leuprolide acetateDRUG
radiation therapyRADIATION

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven localized adenocarcinoma of the prostate * Prostate specific antigen (PSA) greater than 4 or Gleason score at least 8 if PSA is no greater than 4 * CT, MRI, or pelvic lymphadenectomy negative for metastases, if PSA is no greater than 50 * Negative pelvic lymphadenectomy, if PSA is greater than 50 * Bone scan negative for metastases or PSA no greater than 20 PATIENT CHARACTERISTICS: Age: * Not specified Performance Status: * Not specified Life Expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm3 * Platelet count at least 70,000/mm3 * Hemoglobin at least 10 g/dL * Patients on anticoagulant therapy must have a baseline PT test Hepatic: * Bilirubin less than 1.5 times upper limit of normal (ULN) * ALT or AST less than 1.5 times ULN * Alkaline phosphatase less than 1.5 times ULN Renal: * Creatinine less than 1.5 times ULN Cardiovascular: * No history of collagen vascular disease Other: * No acute infection requiring antibiotics * No history of hypersensitivity to flutamide * No history of hypersensitivity to leuprolide acetate PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified

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

Sponsors & Collaborators

Study Sites (1)

Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

Related Publications (1)

  • Heymann JJ, Benson MC, O'Toole KM, Malyszko B, Brody R, Vecchio D, Schiff PB, Mansukhani MM, Ennis RD. Phase II study of neoadjuvant androgen deprivation followed by external-beam radiotherapy with 9 months of androgen deprivation for intermediate- to high-risk localized prostate cancer. J Clin Oncol. 2007 Jan 1;25(1):77-84. doi: 10.1200/JCO.2005.05.0419.

    PMID: 17194907RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

FlutamideLeuprolideRadiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesGonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsTherapeutics

Study Officials

  • Ronald D. Ennis, MD

    Herbert Irving Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

April 18, 2003

Study Start

May 1, 1997

Study Completion

January 1, 2007

Last Updated

January 6, 2014

Record last verified: 2002-12

Locations

US(1)