Clinical trial · Interventional
An Open Label Exploratory Study in Newly Diagnosed Prostate Cancer Patients
An Open Label Study of Exploratory Pharmacogenomics and Pharmacologic Effects of Neoadjuvant Oral Temsirolimus in Newly Diagnosed Prostate Cancer Patients Undergoing Radical Prostatectomy Who Have a High Risk of Relapse
NCT00235794CI-TRIAL-00001065completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Open-label exloratory pharmacodynamic and pharmacogenomic study to evaluate teh biologic effects of 3 dose levels (1mg, 5 mg, and 15 mg) of temsirolimus administered orally once daily for approximately 4 weeks (+/- 2 weeks) before prostatectomy
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 |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| temsirolimus | Drug | Temsirolimus | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the effects of oral temsirolimus on changes in phosphorylation state of proteins in the mTOR signaling pathway in tumor tissue and on phosphorylation state of mTOR pathway proteins and on global and targeted gene expression pattern PBMCs
Secondary outcomes (2)
- measure
- Determine effects of oral temsirolimus on global and targeted gene expression; compare effects in the tumor and PBMCs; obtain preliminary information on potential antitumor effects; evaluate PK using whole blood and tumor tissue.
- measure
- To evaluate the relationship between PTEN status and the pharmacodynamic/pharmacogenomic effects of temsirolimus and to determine the effects of temsirolimus on changes in protein expression patterns in the plasma
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Histologically confirmed diagnosis of adenocarcinoma of the prostate gland via a minimum of 6 core biopsy samples. * Subjects must be a candidate for radical prostatectomy * No evidence of metastatic disease as determined by CT scans and bone scans * More criteria apply Exclusion Criteria: * Subjects from whom sufficient diagnostic biopsy material is not available for full characterization of the tumor * Active Infection requiring antibiotic therapy, or serious intercurrent illness, active bleeding, or ongoing urinary tract infection necessitating rapid or emergent surgical resection * Subjects who have had hormonal injection or implants which will last longer than 6 months * More criteria apply
References
Publications (0)
Data not yet available
No reference posted for this study.