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

• Sponsor: Memorial Sloan Kettering Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00586898
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arm: 1
• Duration (Months): 92
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Prostate; Cancer; Hormonal Cycling	Drug: GnRH; Drug: Ketoconazole; Drug: Bicalutamide; Drug: Testosterone transdermal gel; Drug: Estrogen transdermal patch	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Rapid Hormonal Cycling as Treatment for Patients With Prostate Cancer: The Men's Cycle
• Study Start Date: Jul 1, 2001
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 1

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

Outcome Measures

Primary Outcome Measures

1. Response [6 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

1. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065

Sponsors and Collaborators

• Memorial Sloan Kettering Cancer Center

Investigators

• Principal Investigator: Howard Scher, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Memorial Sloan Kettering Cancer Center

Publications

None provided.

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT00586898
• Other Study ID Numbers: 01-085
• First Posted: Jan 7, 2008
• Last Update Posted: Mar 25, 2016
• Last Verified: Feb 1, 2016

• Keywords provided by Memorial Sloan Kettering Cancer Center: Prostate; Cancer; Hormones; 01-085; ANTIFUNGAL ANTIBIOTICS; ESTROGENS; LUPRON; TESTOSTERONE; ZOLADEX
• Additional relevant MeSH terms: Prostatic Neoplasms; Ketoconazole; Bicalutamide; Testosterone; Estrogens

Study Results

Participant Flow

Arm/Group Title	All Participants
Arm/Group Description	Rapid Hormonal Cycling as Treatment for Patients with Prostate Cancer
Period Title: Overall Study
STARTED	36
COMPLETED	29
NOT COMPLETED	7

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	Rapid Hormonal Cycling as Treatment for Patients with Prostate Cancer
Overall Participants	36
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	16 44.4%
>=65 years	20 55.6%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	36 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Participants
Arm/Group Description	Rapid Hormonal Cycling as Treatment for Patients with Prostate Cancer
Measure Participants	29
Complete Response (CR)	22 61.1%
Partial Response (PR)	4 11.1%
Stable Disease (SD)	3 8.3%

Adverse Events

Arm/Group Title	All Participants
Arm/Group Description	Rapid Hormonal Cycling as Treatment for Patients with Prostate Cancer
All Cause Mortality
	All Participants
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	2/36 (5.6%)
Cardiac disorders
Cardiovascular, other	1/36 (2.8%)	1
Respiratory, thoracic and mediastinal disorders
Pneumonitis	1/36 (2.8%)	1
Other (Not Including Serious) Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	20/36 (55.6%)
General disorders
Hot Flashes	7/36 (19.4%)	7
Metabolism and nutrition disorders
Hyperglycemia	8/36 (22.2%)	8
Hyperkalemia	5/36 (13.9%)	5
Hypoglycemia	2/36 (5.6%)	2
SGPT (ALT)	3/36 (8.3%)	3
Respiratory, thoracic and mediastinal disorders
Dyspnea	6/36 (16.7%)	6

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.