Text Size

Hormone Therapy in Treating Patients With Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:
NCT00003323
First received: November 1, 1999
Last updated: March 15, 2012
Last verified: June 2011
History of Changes
  Purpose

RATIONALE: Male hormones can stimulate the growth of prostate cancer cells. Hormone therapy using flutamide and finasteride may fight prostate cancer by reducing the production of male hormones.

PURPOSE: Phase II trial to study the effectiveness of flutamide and finasteride in treating prostate cancer patients with high PSA levels who were previously treated with radiation therapy or radical prostatectomy.


Condition Intervention Phase
Prostate Cancer
Sexual Dysfunction and Infertility
 Drug: finasteride
Drug: flutamide
Other: quality-of-life assessment
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Potency-Sparing Hormonal Therapy in Patients With Elevated Serum PSA After Radiation Therapy or Radical Prostatectomy for Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cancer and Leukemia Group B:

Primary Outcome Measures:
  • PSA levels [ Time Frame: 1 year post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • QOL issues associated with treatment protocol [ Time Frame: 3 & 6 months ] [ Designated as safety issue: No ]

Enrollment: 101
Study Start Date: May 1998
Estimated Study Completion Date: July 2017
Primary Completion Date: May 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hormone Therapy
Treatment of prostate cancer pts post radiation or surgery with potency sparing hormones
 Drug: finasteride
5 mg/d PO
Drug: flutamide
250 mg PO tid
Other: quality-of-life assessment
Assessment survey administered at baseline, and 3 & 6 months post initiation of treatment

Detailed Description:

OBJECTIVES:

  • Determine the efficacy of finasteride and flutamide in suppressing prostate specific antigen (PSA) levels in patients with elevated PSA after definitive radiation therapy or radical prostatectomy for prostate cancer.
  • Assess sexual function and other quality of life issues during this therapy.
  • Estimate the response to flutamide withdrawal in this group of patients who have not had a major reduction in circulating testosterone levels.
  • Measure the response rate to further hormonal manipulation with combined androgen blockade after the failure of this therapy.
  • Obtain data that may predict more aggressive disease.

OUTLINE: This is a multicenter study.

Patients receive finasteride and flutamide by mouth three times a day. Patients experiencing recurrence or a greater than 4 nu/mL (above 50%) increase in PSA level will discontinue flutamide treatments. Otherwise, patients continue therapy in the absence of unacceptable toxicity or disease progression.

Quality of life is assessed prior to therapy and at 3 and 6 months.

Patients are followed every 3 months for one year and every 6 months thereafter.

PROJECTED ACCRUAL: This study will accrue 100 patients over 2 years.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven previously treated adenocarcinoma of the prostate

  • Prior definitive therapy must have occurred at least 6 months, but no more than 10 years, prior to study

    • Definitive therapy is defined as one of the following:

      • Prior radical prostatectomy
      • Radiotherapy to the prostate no more than 3 months before prostatectomy
      • Brachytherapy
      • Brachytherapy with external beam radiotherapy given as single therapy
      • External beam radiation therapy alone
  • Must have a PSA level between 1-10 nu/mL, with a rise of at least 1 nu/mL above the nadir produced by definitive therapy
  • No evidence of local recurrence
  • No metastatic disease

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • SGOT/SGPT no greater than 2 times ULN

Renal:

  • Creatinine no greater than 2 times ULN

Other:

  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy for prostate cancer

Endocrine therapy:

  • At least 2 years since finasteride or other 5a-reductase inhibitors
  • At least 12 months since prior hormone therapy for prostate cancer
  • No more than 6 months of prior hormone therapy
  • No corticosteroids in excess of standard replacement doses
  • No concurrent systemic steroids
  • No other concurrent antiandrogenic drugs or 5a-reductase inhibitors

Radiotherapy:

  • See Disease Characteristics
  • No concurrent palliative radiotherapy

Surgery:

  • See Disease Characteristics
  • No orchiectomy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003323

  Show 43 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Investigators
Study Chair: Joel Picus, MD Washington University Siteman Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
Picus J, Halabi S, Small E, et al.: Long term efficacy of peripheral androgen blockade on prostate cancer: CALGB 9782. [Abstract] J Clin Oncol 24 (Suppl 18): A-4573, 2006.
Picus J, Halabi S, Small E, et al.: Efficacy of peripheral androgen blockade on prostate cancer: results of CALGB 9782. [Abstract] J Clin Oncol 22 (Suppl 14): A-4559, 396s, 2004.
Picus J, Halabi S, Hussain A, et al.: Efficacy of peripheral androgen blockade on prostate cancer: initial results of CALGB 9782. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-727, 2002.

Responsible Party: Cancer and Leukemia Group B
ClinicalTrials.gov Identifier: NCT00003323     History of Changes
Other Study ID Numbers: CDR0000066274, U10CA031946, CLB-9782
Study First Received: November 1, 1999
Last Updated: March 15, 2012
Health Authority: United States: Federal Government

Keywords provided by Cancer and Leukemia Group B:
adenocarcinoma of the prostate
recurrent prostate cancer
sexual dysfunction and infertility

Additional relevant MeSH terms:
Infertility
Prostatic Neoplasms
Sexual Dysfunctions, Psychological
Genital Diseases, Male
Genital Diseases, Female
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Sexual and Gender Disorders
Mental Disorders
Flutamide
 Hormones
Finasteride
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013