Clinical trial NCT00003323: Hormone Therapy in Treating Patients With Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Sexual Dysfunction and Infertility
Keywords: adenocarcinoma of the prostate
recurrent prostate cancer
sexual dysfunction and infertility
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-08-13
Enrollment: 101
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: PSA levels
timeFrame: 1 year post treatment
Secondary outcomes:
measure: QOL issues associated with treatment protocol
timeFrame: 3 & 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Veterans Affairs Medical Center - Birmingham
state: Alabama
city: La Jolla
country: United States
facility: University of California San Diego Cancer Center
state: California
city: San Francisco
country: United States
facility: Veterans Affairs Medical Center - San Francisco
state: California
city: San Francisco
country: United States
facility: UCSF Cancer Center and Cancer Research Institute
state: California
city: Wilmington
country: United States
facility: CCOP - Christiana Care Health Services
state: Delaware
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
city: Miami Beach
country: United States
facility: CCOP - Mount Sinai Medical Center
state: Florida
city: Chicago
country: United States
facility: Veterans Affairs Medical Center - Chicago (Westside Hospital)
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Cancer Research Center
state: Illinois
city: Iowa City
country: United States
facility: Holden Comprehensive Cancer Center at The University of Iowa
state: Iowa
city: Togus
country: United States
facility: Veterans Affairs Medical Center - Togus
state: Maine
city: Baltimore
country: United States
facility: Marlene & Stewart Greenebaum Cancer Center, University of Maryland
state: Maryland
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: Veterans Affairs Medical Center - Minneapolis
state: Minnesota
city: Columbia
country: United States
facility: Veterans Affairs Medical Center - Columbia (Truman Memorial)
state: Missouri
city: Columbia
country: United States
facility: Ellis Fischel Cancer Center - Columbia
state: Missouri
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University Siteman Cancer Center
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Las Vegas
country: United States
facility: CCOP - Southern Nevada Cancer Research Foundation
state: Nevada
city: Lebanon
country: United States
facility: Norris Cotton Cancer Center
state: New Hampshire
city: Buffalo
country: United States
facility: Veterans Affairs Medical Center - Buffalo
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Manhasset
country: United States
facility: CCOP - North Shore University Hospital
state: New York
city: Manhasset
country: United States
facility: Schneider Children's Hospital at North Shore
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital - Cornell Campus
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center, NY
state: New York
city: Syracuse
country: United States
facility: State University of New York - Upstate Medical University
state: New York
city: Syracuse
country: United States
facility: Veterans Affairs Medical Center - Syracuse
state: New York
city: Syracuse
country: United States
facility: CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
state: New York
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center, UNC
state: North Carolina
city: Durham
country: United States
facility: Veterans Affairs Medical Center - Durham
state: North Carolina
city: Durham
country: United States
facility: Duke Comprehensive Cancer Center
state: North Carolina
city: Winston-Salem
country: United States
facility: CCOP - Southeast Cancer Control Consortium
state: North Carolina
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center at Wake Forest University
state: North Carolina
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Memphis
country: United States
facility: University of Tennessee, Memphis Cancer Center
state: Tennessee
city: Memphis
country: United States
facility: Veterans Affairs Medical Center - Memphis
state: Tennessee
city: White River Junction
country: United States
facility: Veterans Affairs Medical Center - White River Junction
state: Vermont
city: Richmond
country: United States
facility: Veterans Affairs Medical Center - Richmond
state: Virginia
city: Richmond
country: United States
facility: MBCCOP - Massey Cancer Center
state: Virginia
Study officials:
affiliation: Washington University Siteman Cancer Center
name: Joel Picus, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.