Back to resultsRapid Hormonal Cycling as Treatment for Patients With Prostate Cancer: The Men's Cycle
Primary Purpose
Prostate, Cancer, Hormonal Cycling
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GnRH
Ketoconazole
Bicalutamide
Testosterone transdermal gel
Estrogen transdermal patch
Sponsored by
About this trial
This is an interventional treatment trial for Prostate focused on measuring Prostate, Cancer, Hormones, 01-085, ANTIFUNGAL ANTIBIOTICS, ESTROGENS, LUPRON, TESTOSTERONE, ZOLADEX
Eligibility Criteria
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:
- Neoadjuvant treatment prior to radiation therapy or radical prostatectomy, provided that the total duration of exposure does not exceed 10 months.
- 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.
Sites / Locations
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Response
Complete Response: Normalization of the PSA (< or = to 4.0 for patients with castrate metastatic disease, or < 0.5 for patients with a rising PSA) that is maintained on 3 successive evaluations a minimum of 2 weeks apart. Partial Response: Decrease in PSA value by > or = to 50% from baseline value (without normalization) for 3 successive evaluations a minimum of 2 weeks apart. Stabilization: Patients who do not meet the criteria for PR or PROG for at least 90 days will be considered stable.
Secondary Outcome Measures
Full Information
NCT ID
NCT00586898
First Posted
December 21, 2007
Last Updated
February 24, 2016
Sponsor
Memorial Sloan Kettering Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00586898
Brief Title
Rapid Hormonal Cycling as Treatment for Patients With Prostate Cancer: The Men's Cycle
Official Title
Rapid Hormonal Cycling as Treatment for Patients With Prostate Cancer: The Men's Cycle
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
4. Oversight
5. Study Description
Brief Summary
Objective: To determine the response to rapid hormonal cycling in patients with non-castrate prostate cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate, Cancer, Hormonal Cycling
Keywords
Prostate, Cancer, Hormones, 01-085, ANTIFUNGAL ANTIBIOTICS, ESTROGENS, LUPRON, TESTOSTERONE, ZOLADEX
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
GnRH
Other Intervention Name(s)
LUPRON, ZOLADEX
Intervention Description
leuprolide and goserelin are gonadotropin-releasing hormone analogues
Intervention Type
Drug
Intervention Name(s)
Ketoconazole
Other Intervention Name(s)
Nizoral
Intervention Description
An imidazole antifungal agent. reduces adrenal and testicular androgen production in men
Intervention Type
Drug
Intervention Name(s)
Bicalutamide
Other Intervention Name(s)
Casodex
Intervention Description
A pure nonsteroidal antiandrogen
Intervention Type
Drug
Intervention Name(s)
Testosterone transdermal gel
Other Intervention Name(s)
Androgel
Intervention Description
an androgenic anabolic steroid
Intervention Type
Drug
Intervention Name(s)
Estrogen transdermal patch
Other Intervention Name(s)
CLIMARA
Intervention Description
Estradiol is the primary and most potent estrogen
Primary Outcome Measure Information:
Title
Response
Description
Complete Response: Normalization of the PSA (< or = to 4.0 for patients with castrate metastatic disease, or < 0.5 for patients with a rising PSA) that is maintained on 3 successive evaluations a minimum of 2 weeks apart. Partial Response: Decrease in PSA value by > or = to 50% from baseline value (without normalization) for 3 successive evaluations a minimum of 2 weeks apart. Stabilization: Patients who do not meet the criteria for PR or PROG for at least 90 days will be considered stable.
Time Frame
6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Neoadjuvant treatment prior to radiation therapy or radical prostatectomy, provided that the total duration of exposure does not exceed 10 months.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Scher, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center
Learn more about this trial
Rapid Hormonal Cycling as Treatment for Patients With Prostate Cancer: The Men's Cycle
We'll reach out to this number within 24 hrs