Hormone Therapy in Treating Patients With Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00003323
First received: November 1, 1999
Last updated: July 1, 2016
Last verified: July 2016
  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:


Further study details as provided by Alliance for Clinical Trials in Oncology:

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
Study Completion Date: March 2010
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

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
  1. Histologic Documentation: Previous histologic evidence of adenocarcinoma of the prostate.
  2. Prior Treatment:

    2.1 Definitive Local Therapy: Patients must have had a previous attempt at definitive therapy, which is defined as a previous radical prostatectomy or radiation therapy with at least 5500 cGy to the prostate.

    1. Patients may have had both radiation therapy to the prostate and surgical resection, given as definitive therapy, provided they began the radiation therapy within 3 months of their prostatectomy. Also, brachytherapy alone and combinations of brachytherapy and external beam radiation therapy are also allowed, if given as a single therapy, and not given for a rising PSA after the previous therapy.
    2. The previous treatment must have occurred at least 6 months, but no more than 10 years, prior to registration.

    2.2 Previous Hormonal Therapy or Other Treatments: Patients may have had no more than 6 months of hormonal therapy with their other treatment, and must have been off all hormones used for the treatment of prostate cancer including Megace for at least 12 months.

    1. No therapy within 2 years with finasteride or other 5 alpha-reductase inhibitors.
    2. No previous chemotherapy for this malignancy.
    3. No orchiectomy.
    4. No corticosteroids in excess of standard replacement doses for adrenal failure.
  3. Elevated PSA Criteria:

    3.1 Patients must a PSA level between 1 ng/ml and 10 ng/ml, with a rise of at least 1 ng/ml above the nadir produced by definitive therapy. The PSA level must be repeated at least once, one month later to confirm the rise of 1 ng/ml above nadir.

    3.2 After the second PSA has been drawn to confirm the rise, one additional PSA should be drawn as close to the start of therapy as possible. Therefore, a total of three PSAs must be drawn prior to the start of therapy. Only the last two need to be drawn at the same lab (ie, the second confirmatory PSA and the PSA drawn just prior to the start of the trial). The nadir PSA and the initial PSA suggesting a rise can be drawn at outside laboratories. The combination of the nadir PSA and the two PSAs showing a rise of 1.0 ng/ml are used for determining eligibility. The two elevated PSAs must be at least one month apart.

  4. No clear evidence of local recurrence on the digital rectal exam.
  5. No metastatic disease on the CT or bone scan.
  6. Performance status 0-2
  7. Required initial laboratory data

    1. SGOT and/or SGPT ≤2 x upper limits of normal
    2. Creatinine ≤2 x upper limits of normal
    3. Bilirubin ≤2 x upper limits of normal
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003323

  Show 43 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Study Chair: Joel Picus, MD Washington University Siteman Cancer Center
  More Information

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: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00003323     History of Changes
Other Study ID Numbers: CALGB-9782  U10CA031946  CDR0000066274 
Study First Received: November 1, 1999
Last Updated: July 1, 2016
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
adenocarcinoma of the prostate
recurrent prostate cancer
sexual dysfunction and infertility

Additional relevant MeSH terms:
Prostatic Neoplasms
Infertility
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Genital Diseases, Female
Hormones
Flutamide
Finasteride
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Androgen Antagonists
Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on August 24, 2016