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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
N/A
N/A
Open (Enrolling)
Male
Prostate Cancer, Sexual Dysfunction and Infertility

Thank you

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


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.

Inclusion 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

Type of Study:

Interventional

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:

No

Principal Investigator

Joel Picus, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Washington University Siteman Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066274

NCT ID:

NCT00003323

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

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Rhode Island HospitalProvidence, Rhode Island  02903
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
CCOP - North Shore University HospitalManhasset, New York  11030
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer CenterMemphis, Tennessee  38103
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
Mount Sinai Medical Center, NYNew York, New York  10029
New York Presbyterian Hospital - Cornell CampusNew York, New York  10021
Holden Comprehensive Cancer Center at The University of IowaIowa City, Iowa  52242-1009
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Veterans Affairs Medical Center - BirminghamBirmingham, Alabama  35233
Veterans Affairs Medical Center - White River JunctionWhite River Junction, Vermont  05009
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - MemphisMemphis, Tennessee  38104
Veterans Affairs Medical Center - RichmondRichmond, Virginia  23249
Veterans Affairs Medical Center - TogusTogus, Maine  04330
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial)Columbia, Missouri  65201
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
Veterans Affairs Medical Center - DurhamDurham, North Carolina  27705
Schneider Children's Hospital at North ShoreManhasset, New York  11030
Washington University Siteman Cancer CenterSaint Louis, Missouri  63110