Randomized Trial of Adjuvant Hormonal Therapy in Surgically Treated Prostate Cancer Patients at High Risk for Recurrence

NCT00003645 | Terminated Phase 3 Results FDA Drug

• 7 other identifiers: ID97-077P30CA016672MDA-ID-97077E-97077NCI-T97-0069CDR0000066733NCI-2009-00818
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy using leuprolide and flutamide may fight prostate cancer by reducing the production of testosterone. It is not yet known whether receiving leuprolide and flutamide is more effective than receiving no further therapy. PURPOSE: Randomized phase III trial to determine the effectiveness of hormone therapy in treating patients who have stage I or stage II prostate cancer that is at high risk of recurrence and who have already undergone surgery.

Conditions

Prostate Cancer

Keywords

stage I prostate cancer; stage II prostate cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Disease Free Survival at 5 Years

  To determine if one year of adjuvant hormonal ablation in node negative radical prostatectomy patients at high risk for progression will result in an improvement in disease-free survival at five years.

  Beginning of the study up to 5 years

Other Outcomes (3)

• Number of Wives of the Participants Having Better Than or Equal to a "Good" Quality of Life

  2 years

• Quality of Life for Participants

  1 year

• Markers of Prognosis

  1 year after treatment

Study Arms (2)

Arm I - Leuprolide + Flutamide

EXPERIMENTAL

Arm I: Patients receive leuprolide intramuscularly once every 3 months and oral flutamide three times daily for 1 year.

Drug: Flutamide; Drug: Leuprolide Acetate

Arm II - No Treatment

NO INTERVENTION

Arm II: Patients receive no initial treatment.

Interventions

Flutamide DRUG

10.8 mg intramuscularly once every 3 months for 12 months

Also known as: Goserelin, Zoladex

Arm I - Leuprolide + Flutamide

Leuprolide Acetate DRUG

50 mg tablet orally daily for 12 months

Also known as: Casodex, Bicalutamide

Arm I - Leuprolide + Flutamide

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Organ confined prostate cancer (stage T1-T2c) subsequent to clinical staging
• Radical prostatectomy and bilateral lymph node dissection performed
• Pathologic assessment of surgical specimens by MDACC pathologist
• High risk of clinical or biochemical failure post prostatectomy (must fulfill one of the following criteria): pathology; a) Gleason grade sum score greater than or equal to 8, b) Seminal vesicle involvement, c) Extraprostatic extension with positive surgical margins and Gleason greater than or equal to 7
• Radical prostatectomy performed within 90 days of enrollment and serum PSA level \< 0.1ng/ml
• Written informed consent

You may not qualify if:

• Any evidence of metastatic disease confirmed prior to enrollment
• Inability to confirm pathologic risk factors or inadequate prostatectomy (see item 4.1.5).
• Hormonal ablation for greater than 3 months or radiotherapy for prostate cancer
• Failure to achieve prostate specific antigen level of less than 0.1ng/ml prior to enrollment in study
• Elevation of liver function tests 2x normal
• Contraindication to the use of LH-RH agonists or antiandrogens
• Active secondary malignancy (other than squamous or basal cell skin cancer) within five years prior to enrollment in study
• Any concomitant medical condition that would make it undesirable for the 7patient to participate in the trial or jeopardize compliance with the protocol

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• Eastern Cooperative Oncology Group: collaborator
• AstraZeneca: collaborator

Study Sites (1)

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Official Website

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Flutamide; Goserelin; Leuprolide; bicalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Dr. Curtis A. Pettaway, M.D.- Professor, Urology
• Organization: UT MD Anderson Cancer Center

cpettawa@mdanderson.org

713-792-7734

Study Officials

• Curtis A. Pettaway, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

• Michael O. Koch, MD

  Indiana University Melvin and Bren Simon Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: July 15, 2003
• Study Start: June 14, 1999
• Primary Completion: March 20, 2017
• Study Completion: March 20, 2017
• Last Updated: April 28, 2020
• Results First Posted: April 28, 2020

Record last verified: 2020-04

Locations

US (1)