Intermittent Hormone Therapy in Men With Localized Prostate Cancer After Radiation Therapy or Radical Prostatectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2011 by University of Washington
Sponsor:
Collaborator:
Sanofi
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00223665
First received: September 16, 2005
Last updated: January 19, 2011
Last verified: January 2011
  Purpose

Sometimes blood levels of prostatic specific antigen (PSA) will rise in men who have had prostate surgery or received radiation therapy for localized prostate cancer. A low value for the PSA is more desirable as is may indicate no tumor growth. Giving the hormone therapy intermittently (in cycles of treatment and off treatment periods) appears to delay the change of prostate cancer to a type of prostate cancer that resists hormone therapy. If it does, the prostate cancer will be treatable for a longer period of time, as well as improve the quality of life. Mental functioning is monitored during therapy to see if this treatment has any impact on memory or ability to carry out tasks. In addition, extra tubes of blood are obtained to test for Amyloid-B protein (AB protein) whose presence may be associated with problem solving decline.


Condition Intervention Phase
Prostate Cancer
Drug: Flutamide
Drug: Leuprolide Acetate
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Study of Intermittent Androgen Suppression in Men With Localized Prostate Cancer Who Have Biochemical Relapse After Radiation Therapy or Radical Prostatectomy

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • PSA levels [ Time Frame: Monthly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life, bone/body scans, blood tests [ Time Frame: Annually ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 1997
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Intermittent Hormone Therapy
Drug: Flutamide
250 mg tid
Drug: Leuprolide Acetate
7.5 mg q month

Detailed Description:

This study evaluates the effect of intermittent androgen suppression on time to androgen independent progression and overall survival in men with localized prostate cancer. Subjects will also be evaluated for the effects of intermittent androgen suppression on quality of life and on musculoskeletal, cardiovascular, and neuropsychiatric systems.

The subjects in this study will have a rising PSA value after definitive therapy either with radical prostatectomy or external beam irradiation for the treatment of prostate cancer. All subjects will be male, and they will be over the age of 18 years.

New subjects will be introduced to this study protocol (along with other non-study treatment options) during a clinic visit with Dr. Higano or another sub-investigator. If informed consent is obtained, subjects will undergo the following screening procedures before starting treatment: Bone density scan; bone scan; CT scan of the chest, abdomen, and pelvis; blood draw; problem solving test; quality of life and emotion questionnaires; and a body composition test. Subjects will then begin androgen suppression with a two-week lead-in of flutamide, followed by 9 monthly injections of leuprolide acetate. During the treatment, they will have quarterly clinic visits and blood draws for hematology, chemistry, liver function, and lipids. Their PSA levels are monitored monthly, and if their PSA reaches the appropriate nadir at by month 9, the androgen suppression is interrupted. At the end of each treatment cycle, subjects will undergo another bone density test, blood draw, body composition test, problem solving test, and complete the quality of life and emotion questionnaires.

During the "off treatment" phase, the subject will again have quarterly clinic visits, blood draw for chemistry, hematology, liver function, and lipids, as well as having quarterly cognitive function test. PSA and testosterone will be monitored monthly. Once the PSA reaches the appropriate threshold, the subject will perform another set of screening procedures and resume treatment for another 9 months. This cycle continues until the patient withdraws from the study, is taken off the study due to toxicities or the decision of the investigator, or if the treatment is no longer effective in controlling the prostate cancer. The problem solving tests are only performed during the subject's first cycle of treatment (consisting of the 9 months on treatment, and the entire off treatment period afterwards).

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biochemical relapse (rising PSA) after initial treatment (radiation therapy, brachytherapy, or radical prostatectomy) for histologically or cytologically confirmed adenocarcinoma of the prostate
  • Clinical stage A2, B, C, D1
  • Age: older than 21 years old
  • Performance status of 0 or 1
  • Pretreatment serum testosterone, normal range (or no clinical evidence of testosterone deficiency).
  • If less than 30 months since completion of radiation therapy, biopsy of prostate suggested within 6 months of study entry.
  • If more than or equal to 30 months since completion of radiation therapy, biopsy of prostate suggested within 1 year.
  • Written informed consent.

Exclusion Criteria:

  • Abnormal bone scan suggestive of metastatic osseous disease.
  • Previous hormonal manipulation including orchiectomy or any medication with significant antiandrogenic activity (combined androgen suppression over 9 months, monotherapy antiandrogens, estrogens, ketoconazole). *Neoadjuvant androgen suppression therapy of less than or equal to 3 months is allowed, if this androgen suppression therapy was completed more than or equal to 1 year prior to study enrollment AND if the Testosterone level is within the normal ranges.
  • Any systemic chemotherapy or curative radiotherapy within 6 months.
  • Hepatic dysfunction (bilirubin: greater than 2.0 mg/dl and/or SGOT, LDH: greater than 3 times the upper limit of normal range).
  • Renal dysfunction (BUN: greater than 40 mg/dl and/or creatinine: greater than 2.0 mg/dl).
  • History or presence of other malignancy within the last 5 years (except treated squamous/basal cell carcinoma of the skin or superficial bladder carcinoma).
  • Hypersensitivity to flutamide or leuprolide.
  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: NCT00223665

Contacts
Contact: Jackie Sprinkle 206.288.1189 jsprinkle@uw.edu
Contact: Teresa Gambol 206.288.6452 tgambol@seattlecca.org

Locations
United States, Washington
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Contact: Jackie Sprinkle    206-288-1189    jsprinkle@uw.edu   
Contact: Teresa Gambol    206.288.6452    tgambol@seattlecca.org   
Sponsors and Collaborators
University of Washington
Sanofi
Investigators
Principal Investigator: Celestia Higano, MD University of Washington
  More Information

No publications provided

Responsible Party: Celestia Higano, MD, University of Washington
ClinicalTrials.gov Identifier: NCT00223665     History of Changes
Other Study ID Numbers: 30296-A, L-8863, 06-2040-A-02
Study First Received: September 16, 2005
Last Updated: January 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Intermittent Hormone Therapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Flutamide
Leuprolide
Hormones
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on August 28, 2014