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

Phase 1
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

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

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.

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

- 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

- Patients with known skin allergies to polyester, alcohol, aluminum, or silicone.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Description:

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

Outcome Time Frame:

1-4 years

Safety Issue:


Principal Investigator

Walter M Stadler, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago


United States: Institutional Review Board

Study ID:




Start Date:

June 2004

Completion Date:

February 2009

Related Keywords:

  • Prostate Cancer
  • 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
  • Prostatic Neoplasms



University of ChicagoChicago, Illinois  60637