Clinical trial · Interventional
Testosterone Replacement in Men With Non-Metastatic Castrate Resistant Prostate Cancer
A Randomized, Double Blind, Placebo-Controlled Phase II Study of Testosterone Replacement in Men With Non-Metastatic Castrate Resistant Prostate Cancer
NCT00515112CI-TRIAL-00014819terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): This study has been terminated due to poor accrual
Summary
Brief summary (as posted)
The purpose of this study is to determine whether prostate cancer growth can be slowed in patients who receive Androgel® 1% at 10 gram dose.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AndroGel | Drug | — | UNRESOLVED |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- Twenty subjects will receive testosterone gel
- interventionNames
- Drug: AndroGel
- type
- PLACEBO_COMPARATOR
- label
- B
- description
- Twenty subjects will receive the placebo
- interventionNames
- Drug: placebo
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- Up to 5 years
- description
- Time to progression is measured from the date of randomization until the onset of the earliest of one of the following events: in the absence of a 50% decline in prostate-specific antigen (PSA), a PSA increase to 3 times the nadir PSA or an absolute PSA value of 50 ng/ml, whichever comes first; if at least a 50% decline in PSA is achieved from PSA peak value, a PSA increase of 50% above the nadir provided the increase is at least 5 ng/ml or back to baseline; one or more new skeletal lesions as shown on any bone scan or minimum of 1.5 cm in longest diameter on any computed tomography or magnetic resonance imaging scan; tumor flair; the occurrence of a clinical event, including death, determined by the investigator to represent disease progression.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGeynisman DM, Szmulewitz RZ, Stadler WM. A trial postmortem: challenges in conducting a randomized, double-blind, phase 2 study in men with castration-resistant prostate cancer. Eur Urol. 2012 Nov;62(5):864-6. doi: 10.1016/j.eururo.2012.08.030. Epub 2012 Aug 25. No abstract available. PMID 22939385