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

November 27, 2023 updated by: University of Chicago

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Most hormone-refractory disease is currently defined by rising PSA following androgen ablation and an antiandrogen. These patients are typically asymptomatic and have minimal or no radiologically evident disease by standard bone and CT scans. Therapeutic options are limited, with 3rd line hormonal treatments generally providing only brief durations of benefit in a small minority of patients. Chemotherapy is effective, but the role of this somewhat toxic approach in the asymptomatic patient is debatable. In addition, patients suffer from the long-term side effects of androgen ablation such as muscle wasting, decreased strength, decreased sexual functioning, and impaired cognition. If the hypothesis that androgen replacement can inhibit cancer growth in androgen insensitive patients is correct, such treatment would not only delay disease progression but could also improve quality of life. If the hypothesis is incorrect and androgens actually stimulate growth, the consequences are unlikely to be catastrophic since the selected population has only a minimal disease burden.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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:
  • total bilirubin within normal institutional limits
  • AST(SGOT)/ALT(SGPT) <1.5 X institutional upper limit of normal
  • Patient has had no other active malignancies with the exception of non-melanoma skin cancer.
  • Patient must possess the ability to understand and be willing to sign a written informed consent document.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Androderm® 2.5mg
Study subjects will be randomized to one of the study arms: 2.5 mg of Androderm®.
Drug: Androderm® 2.5mg
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.
Experimental: Androderm® 5.0 mg
Study subjects will be randomized to one of the study arms: 5.0 mg of Androderm®.
Drug: Androderm® 5.0mg
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.
Experimental: Androderm® 7.5mg
Study subjects will be randomized to one of the study arms: 7.5 mg of Androderm®.
Drug: Androderm® 7.5mg
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 1-4 years
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 3-5 years
To determine the effects of Androderm® 2.5 mg, 5.0 mg, and 7.5 mg on total and free testosterone levels and PSA. To determine the effects of Androderm® 2.5 mg, 5.0 mg, and 7.5 mg on QOL, sexual functioning, and muscle strength.
3-5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Chicago

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Walter M Stadler, MD, University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2010

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 13183B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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