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A Phase II Trial of Potency-Sparing Hormonal Therapy in Patients With Elevated Serum PSA After Radiation Therapy or Radical Prostatectomy for Prostate Cancer

Phase 2
Open (Enrolling)
Prostate Cancer, Sexual Dysfunction and Infertility

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Trial Information

A Phase II Trial of Potency-Sparing Hormonal Therapy in Patients With Elevated Serum PSA After Radiation Therapy or Radical Prostatectomy for Prostate Cancer


- 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.

Inclusion Criteria


- 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



- Not specified

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified


- Not specified


- Bilirubin no greater than 2 times upper limit of normal (ULN)

- SGOT/SGPT no greater than 2 times ULN


- Creatinine no greater than 2 times ULN


- Fertile patients must use effective contraception


Biologic therapy:

- Not specified


- 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


- See Disease Characteristics

- No concurrent palliative radiotherapy


- See Disease Characteristics

- No orchiectomy

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PSA levels

Outcome Time Frame:

1 year post treatment

Safety Issue:


Principal Investigator

Joel Picus, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Washington University Siteman Cancer Center


United States: Federal Government

Study ID:




Start Date:

May 1998

Completion Date:

July 2017

Related Keywords:

  • Prostate Cancer
  • Sexual Dysfunction and Infertility
  • adenocarcinoma of the prostate
  • recurrent prostate cancer
  • sexual dysfunction and infertility
  • Infertility
  • Prostatic Neoplasms
  • Sexual Dysfunctions, Psychological



Roswell Park Cancer Institute Buffalo, New York  14263
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
University of Chicago Cancer Research Center Chicago, Illinois  60637
University of Massachusetts Memorial Medical Center Worcester, Massachusetts  01655
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Rhode Island Hospital Providence, Rhode Island  02903
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
University of California San Diego Cancer Center La Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore, Maryland  21201
Ellis Fischel Cancer Center - Columbia Columbia, Missouri  65203
Barnes-Jewish Hospital Saint Louis, Missouri  63110
Norris Cotton Cancer Center Lebanon, New Hampshire  03756
CCOP - North Shore University Hospital Manhasset, New York  11030
State University of New York - Upstate Medical University Syracuse, New York  13210
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer Center Memphis, Tennessee  38103
MBCCOP - Massey Cancer Center Richmond, Virginia  23298-0037
Mount Sinai Medical Center, NY New York, New York  10029
New York Presbyterian Hospital - Cornell Campus New York, New York  10021
Holden Comprehensive Cancer Center at The University of Iowa Iowa City, Iowa  52242-1009
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Veterans Affairs Medical Center - Birmingham Birmingham, Alabama  35233
Veterans Affairs Medical Center - White River Junction White River Junction, Vermont  05009
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Veterans Affairs Medical Center - Chicago (Westside Hospital) Chicago, Illinois  60612
Veterans Affairs Medical Center - San Francisco San Francisco, California  94121
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse, New York  13217
Veterans Affairs Medical Center - Memphis Memphis, Tennessee  38104
Veterans Affairs Medical Center - Richmond Richmond, Virginia  23249
Veterans Affairs Medical Center - Togus Togus, Maine  04330
Veterans Affairs Medical Center - Minneapolis Minneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial) Columbia, Missouri  65201
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Veterans Affairs Medical Center - Buffalo Buffalo, New York  14215
Veterans Affairs Medical Center - Syracuse Syracuse, New York  13210
Veterans Affairs Medical Center - Durham Durham, North Carolina  27705
Schneider Children's Hospital at North Shore Manhasset, New York  11030
Washington University Siteman Cancer Center Saint Louis, Missouri  63110