Know Cancer

forgot password

A Prospective Study of Intermittent Androgen Suppression in Men With Localized Prostate Cancer Who Have Biochemical Relapse After Radiation Therapy or Radical Prostatectomy

Phase 2
21 Years
Open (Enrolling)
Prostate Cancer

Thank you

Trial Information

A Prospective Study of Intermittent Androgen Suppression in Men With Localized Prostate Cancer Who Have Biochemical Relapse After Radiation Therapy or Radical Prostatectomy

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

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

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

PSA levels

Outcome Time Frame:


Safety Issue:


Principal Investigator

Celestia Higano, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Washington


United States: Institutional Review Board

Study ID:




Start Date:

January 1997

Completion Date:

December 2014

Related Keywords:

  • Prostate Cancer
  • Intermittent Hormone Therapy
  • Prostatic Neoplasms



Seattle Cancer Care Alliance Seattle, Washington  98109