A Randomized Study of Testosterone Replacement in Patients With Low Risk Hormone Refractory Prostate Cancer

NCT01187485 | Completed Phase 1

• 1 other identifier: 13183B
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see how safe Androderm® (the study drug) is at three different doses in subjects with early hormone refractory prostate cancer. In addition, information about hormonal levels and the effects of testosterone on quality of life including sexual functioning and muscle strength will be collected.

Conditions

Prostate Cancer

Keywords

Androderm®; Testosterone; refractory; prostate; cancer; Patients with "hormone refractory" prostate cancer will be treated with a daily testosterone patch Androderm® applied every 24 hours to the skin

Outcome Measures

Primary Outcomes (1)

• Primary Study Objective is to determine the safety of Androderm® 2.5 mg, 5.0 mg, and 7.5 mg in patients with early hormone refractory prostate cancer.

  To determine the safety of Androderm® 2.5 mg, 5.0 mg, and 7.5 mg in patients with early hormone refractory prostate cancer.

  1-4 years

Secondary Outcomes (1)

• Secondary Study Objectives are to determine the effects of Androderm® 2.5 mg, 5.0 mg, and 7.5 mg on total and free testosterone levels and PSA as well as on QOL, sexual functioning, and muscle strength.

  3-5 years

Study Arms (3)

Androderm® 2.5mg

EXPERIMENTAL

Study subjects will be randomized to one of the study arms: 2.5 mg of Androderm®.

Drug: Androderm® 2.5mg

Androderm® 5.0 mg

EXPERIMENTAL

Study subjects will be randomized to one of the study arms: 5.0 mg of Androderm®.

Drug: Androderm® 5.0mg

Androderm® 7.5mg

EXPERIMENTAL

Study subjects will be randomized to one of the study arms: 7.5 mg of Androderm®.

Drug: Androderm® 7.5mg

Interventions

Androderm® 2.5mg DRUG

Subjects will be asked to replace the study drug patch every 24 hours at night following the written and verbal instructions you will receive. The study drug patch should be placed over a small amount of a steroid cream on the skin to reduce irritation.

Androderm® 2.5mg

Androderm® 5.0mg DRUG

Subjects will be asked to replace the study drug patch every 24 hours at night following the written and verbal instructions you will receive. The study drug patch should be placed over a small amount of a steroid cream on the skin to reduce irritation.

Androderm® 5.0 mg

Androderm® 7.5mg DRUG

Subjects will be asked to replace the study drug patch every 24 hours at night following the written and verbal instructions you will receive. The study drug patch should be placed over a small amount of a steroid cream on the skin to reduce irritation.

Androderm® 7.5mg

Eligibility Criteria

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

You may qualify if:

• Patient has a histologically documented diagnosis of prostate adenocarcinoma (PCa) not amenable to curative treatment with surgery or radiation treatment.
• Patient was surgically or pharmacologically castrated at least 6 months prior to randomization. Castration must be verified by a screening testosterone value of \<30 ng/dL. Any patient pharmacologically castrated must be maintained on androgen suppression therapy for the duration of the study.
• Patient must have had a previous trial of anti-androgen therapy.
• Patients must have a documented anti-androgen withdrawal period prior to randomization: flutamide requires a minimum 4 weeks withdrawal, and nilutamide and bicalutamide require a minimum 6 weeks withdrawal.
• Patient must meet one of the following PSA criteria:
• A 50% rise in PSA values within a minimum rise to at least 3.0 ng/mL, within 6 months prior to randomization, OR
• A rising PSA defined as two sequential increases in PSA values. The following data are required: an initial value (#1) followed by a PSA value demonstrating an increase (#2). The increase must be confirmed by another rise in PSA (#3) (3\>2\>1). There must be at least 2 weeks between each qualifying PSA value and the absolute PSA value at enrollment must be at least 3.0 ng/ml.
• At the time of screening the patient must have no evidence of visceral organ-confined metastatic disease OR the presence of minimal bone metastases only without evidence of visceral organ-confined metastatic disease.
• The absence of visceral organ-confined metastatic disease is defined as:
• No organ-confined soft tissue metastases (e.g. lung, liver, etc.) as verified by chest/abdomen/pelvic CT scan.
• The presence of pathologically enlarged lymph nodes will not exclude subjects from the study and will not be included in the definition of visceral organ-confined metastatic disease.
• The presence of minimal bone metastases is defined as \<1.4% by Bone Scan Index criteria (see section 9).
• ECOG performance status \<2 (Karnofsky \>70%, see Appendix A).
• Age \>18 years. Because no dosing or adverse event data are currently available on the use of Androderm® in the context of androgen ablation in patients \<18 years of age, children are excluded from this study but will be eligible for future pediatric phase 1 single-agent trials.
• Patients must have normal hepatic and renal function as defined below:

You may not qualify if:

• Patients with a history of any previous cytotoxic therapy or radionuclide therapy (such as rhenium, strontium, or samarium).
• Patients may not be receiving any other investigational agents.
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Patients with evidence of visceral organ-confined metastases other than minimal bone metastases (as defined by \<1.4% Bone Scan Index, see section 9) and/or pathologically enlarged lymph nodes will be excluded.
• Patients with local recurrences who are candidates for local salvage therapy (e.g. surgery, radiation, brachytherapy, cryotherapy) will be excluded.
• Patients with significant pulmonary disease who have received chronic or pulse steroid therapy within the last 3 months prior to randomization will be excluded. Steroid therapy for non-pulmonary, non-oncologic conditions are allowed if the patient has been on a chronic, steady-dose regimen for a minimum of 2 months prior to randomization.
• Patients with known skin allergies to polyester, alcohol, aluminum, or silicone.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Walter M Stadler, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2010
• First Posted: August 24, 2010
• Study Start: June 1, 2004
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2009
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

US (1)