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A Randomized, Double Blind, Placebo-Controlled Phase II Study of Testosterone Replacement in Men With Non-Metastatic Castrate Resistant Prostate Cancer


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

A Randomized, Double Blind, Placebo-Controlled Phase II Study of Testosterone Replacement in Men With Non-Metastatic Castrate Resistant Prostate Cancer


The primary objective of the study is to determine the effect of testosterone replacement on
time to disease progression and time to clinical cancer progression.

The secondary objectives are to describe the effect of testosterone replacement on
patient-reported quality of life (FACT-P, FACT-fatigue and specific measures from the
Expanded Prostate Cancer Index (EPIC): Sexual and Hormonal Assessments), and hand-grip
strength; to describe changes in total testosterone, free testosterone, and PSA levels; to
explore AR levels in circulating tumor cells as a marker of treatment benefit.


Inclusion Criteria:



- Prostate cancer

- Patient must have received primary definitive local therapy to the prostate (surgery
and/or radiotherapy)

- Patient was surgically or pharmacologically castrated at least 6 months prior to
starting the study

- Patient must have had a previous trial of anti-androgen therapy

- Patient must have a rising PSA

- No evidence of distant metastatic disease

- ECOG performance status < 2

- Age >18 years

- Patients must have normal hepatic function

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,
uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would
limit compliance with study requirements

- Patients receiving renal dialysis

- Patients with significant pulmonary disease who have received chronic or pulse
steroid therapy within the last 3 months prior to randomization will be excluded

- Patients who have known hypersensitivity to any of the AndroGel ingredients,
including testosterone that is chemically synthesized from soy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

The primary objective of the study is to determine the effect of testosterone replacement progression and time to clinical cancer progression.

Outcome Time Frame:

time to progression evaluated every 8 weeks

Safety Issue:

No

Principal Investigator

Walter Stadler, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago

Authority:

United States: Food and Drug Administration

Study ID:

15393B

NCT ID:

NCT00515112

Start Date:

July 2007

Completion Date:

August 2012

Related Keywords:

  • Prostate Cancer
  • prostate
  • cancer
  • testosterone replacement
  • AndroGel
  • prostatic cancer
  • prostatic neoplasms
  • Prostatic Neoplasms

Name

Location

Baylor College of MedicineHouston, Texas  77030
Medical College of WisconsinMilwaukee, Wisconsin  53226
Ingalls Memorial HospitalHarvey, Illinois  60426
University of ColoradoDenver, Colorado  80217
Northwestern UniversityChicago, Illinois  60611
University of MarylandBaltimore, Maryland  21201
University of ChicagoChicago, Illinois  60637
Illinois Cancer CarePeoria, Illinois  61615
University of Southern CaliforniaLos Angeles, California  90033
NorthShore University Helath SystemEvnaston, Illinois  60201
University of RochesterRochester, Maryland  14642