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Rapid Hormonal Cycling as Treatment for Patients With Prostate Cancer: The Men's Cycle

Phase 2
18 Years
Not Enrolling
Prostate, Cancer, Hormonal Cycling

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Trial Information

Rapid Hormonal Cycling as Treatment for Patients With Prostate Cancer: The Men's Cycle

Inclusion Criteria:

-Patients residing in the following clinical states wit! be considered: A. Rising PSA:
Patients with a history of localized disease who have undergone definitive radiation or
surgery. These patients must demonstrate progression of disease biochemically as outlined
below. Patients in this group may not have radiographically evident disease.

B. Non-castrate metastatic: Patients must present with radiographic evidence of metastatic
disease at the time of diagnosis or after treatment for localized disease. These patients
must show newly detected disease or progressing disease in bone or in soft tissue.
Biochemical progression is defined as: minimum no. of determinations: 3 Interval: >2 weeks
Minimal Baseline PSA value (ng/ml): 2 Minimal % increase in range of values: 50%

- Diagnosis of prostate adenocarcinoma histologically confirmed at MSKCC.

- Patient must have level of serum testosterone above the lower limit of normal.

- Karnofskcy performance status (KPS) >_70%.

- Patients must have adequate organ function as defined by the following laboratory

- WBC >_3500/mm3, platelet count >_100,000/mm3.

- Bilirubin <2.0 mg/dl or SGOT <3.0 X the upper limit of normal.

- Creatinine <_1.6 mg/dl or creatinine clearance >_60 cc/min.

- Prior hormonal therapy is allowed as:

1. Neoadjuvant treatment prior to radiation therapy or radical prostatectomy,
provided that the total duration of exposure does not exceed 10 months.

2. One cycle of intermittent therapy up to a maximum exposure of 10 months.

- Patients must be at least 18 years of age.

- Patients must have signed an informed consent document stating that they understand
the investigational nature of the proposed treatment

Exclusion Criteria:

- Clinically significant cardiac disease (New York Heart Association Class III/IV),or
severe debilitating puhnonary disease.

- Uncontrolled serious active infection.

- Anticipated survival of less than 3 months.

- Active CNS or epiduraltumor

- Inability or unwillingness to comply with the treatment protocol, follow-up, or
research tests.

Type of Study:


Study Design:

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

Outcome Measure:

To determine the response to rapid hormonal cycling in patients with non-castrate prostate cancer.

Outcome Time Frame:

completion of study

Safety Issue:


Principal Investigator

Howard Scher, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

July 2001

Completion Date:

March 2009

Related Keywords:

  • Prostate
  • Cancer
  • Hormonal Cycling
  • Prostate
  • Cancer
  • Hormones
  • 01-085
  • Prostatic Neoplasms



Memorial Sloan Kettering Cancer CenterNew York, New York  10021