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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00586898
• Other study ID #: 01-085
• Status: Completed
• Phase: Phase 2
• First received: December 21, 2007
• Last updated: March 5, 2015
• Start date: July 2001
• Est. completion date: March 2009

Study information

• Verified date: March 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 criteria:

• 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.

Study Design

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

Related Conditions & MeSH terms

• Cancer
• Hormonal Cycling
• Prostate

Intervention

Drug:
• GnRH
leuprolide and goserelin are gonadotropin-releasing hormone analogues
• Ketoconazole
An imidazole antifungal agent. reduces adrenal and testicular androgen production in men
• Bicalutamide
A pure nonsteroidal antiandrogen
• Testosterone transdermal gel
an androgenic anabolic steroid
• Estrogen transdermal patch
Estradiol is the primary and most potent estrogen

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the response to rapid hormonal cycling in patients with non-castrate prostate cancer.		completion of study	No

External Links

•   Memorial Sloan Kettering Cancer Center