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

NCT00586898 | Completed Phase 2 Results

• 1 other identifier: 01-085
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate; Cancer; Hormonal Cycling

Keywords

Prostate; Cancer; Hormones; 01-085; ANTIFUNGAL ANTIBIOTICS; ESTROGENS; LUPRON; TESTOSTERONE; ZOLADEX

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Study Arms (1)

1

EXPERIMENTAL

Drug: GnRH; Drug: Ketoconazole; Drug: Bicalutamide; Drug: Testosterone transdermal gel; Drug: Estrogen transdermal patch

Interventions

GnRH DRUG

leuprolide and goserelin are gonadotropin-releasing hormone analogues

Also known as: LUPRON, ZOLADEX

1

Ketoconazole DRUG

An imidazole antifungal agent. reduces adrenal and testicular androgen production in men

Also known as: Nizoral

1

Bicalutamide DRUG

A pure nonsteroidal antiandrogen

Also known as: Casodex

1

Testosterone transdermal gel DRUG

an androgenic anabolic steroid

Also known as: Androgel

1

Estrogen transdermal patch DRUG

Estradiol is the primary and most potent estrogen

Also known as: CLIMARA

1

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Neoplasms

Interventions

Gonadotropin-Releasing Hormone; Leuprolide; Goserelin; Ketoconazole; bicalutamide; Testosterone; Estradiol

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Estrenes; Estranes; Estradiol Congeners

Results Point of Contact

• Title: Dr. Howard Scher
• Organization: Memorial Sloan Kettering Cancer Center

Scherh@mskcc.org

646-422-4323

Study Officials

• Howard Scher, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 7, 2008
• Study Start: July 1, 2001
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: March 25, 2016
• Results First Posted: March 25, 2016

Record last verified: 2016-02

Locations

US (1)