Clinical trial · Interventional
Sirolimus Before Surgery in Treating Patients With Advanced Localized Prostate Cancer
A Pharmacodynamic Study of Pre-Prostatectomy Rapamycin in Men With Advanced Localized Prostate Cancer
NCT00311623CI-TRIAL-00037220completedPhase 1 / Phase 2Results postedClinicalTrials.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)
RATIONALE: Drugs used in chemotherapy, such as sirolimus, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This clinical trial is studying the best dose of sirolimus and to see how well it works before surgery in treating patients with advanced localized prostate cancer.
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 (3)
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- Men \>18years old with prostate cancer clinical stages T1c to T3, no metastases, Gleason sum of 7-10, multiple positive diagnostic cores, Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, candidates for radical prostatectomy. Receive no intervention on Days 1-14. Surgery performed on Day 15.
- interventionNames
- Procedure: Radical prostatectomy
- type
- EXPERIMENTAL
- label
- Low-dose Rapamycin (3mg)
- description
- Men \>18years old with prostate cancer clinical stages T1c to T3, no metastases, Gleason sum of 7-10, multiple positive diagnostic cores, Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, candidates for radical prostatectomy. Must have adequate hepatic, renal and bone marrow function, no allergy to rapamycins, avoid medications interfering with rapamycin metabolism, no active infection, no prior therapies for prostate cancer. Will receive rapamycin 3mg (Wyeth Pharmaceuticals, 1mg tablets) oral (PO) once daily on Days 1-14 with the last dose given on the morning before surgery (Day 15).
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically determined adenocarcinoma of the prostate * Stage T1c-T3b disease * No evidence of disease that has spread beyond the prostate or seminal vesicles * No metastatic prostate cancer, including bone, visceral, brain, and lymph node metastases * Tumor Gleason score sum of 7-10 (4+3 and 3+4 allowed) with tumor involving at least 2 discrete core biopsy sections * Scheduled to undergo radical prostatectomy * No other subtypes of prostate cancer, including any of the following: * Sarcoma * Neuroendocrine tumors * Small cell cancer * Ductal cancer * Lymphoma PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * WBC \> 3,500/mm\^3 * Absolute neutrophil count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * Hemoglobin \> 9 g/dL * Creatinine \< 2.0 mg/dL * Bilirubin \< 2 mg/dL * ALT and AST \< 2 times upper limit of normal (ULN) * Alkaline phosphatase \< 2 times ULN * Triglycerides and total cholesterol \< 2 times ULN * No history of allergy to sirolimus (rapamycin) or its derivatives * No uncontrolled medical condition that would increase risk or limit compliance with study requirements, including the following: * Immunodeficiency * Gastrointestinal disease that would limit ability to swallow, take oral medications, or absorb them * No active infections * No other concurrent malignancy PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior chemotherapy, biologic therapy, radiotherapy, or immunotherapy for prostate cancer * No concurrent chronic treatment with immunosuppressants or medications that interfere with the metabolism of sirolimus (rapamycin) * No concurrent medication or agents that would interfere with the metabolism or excretion of rapamycin or its derivatives, including any of the following: * Phenytoin * Carbamazepine * Cyclosporine * Clarithromycin * Clotrimazole * Erythromycin * Amiodarone * Protease inhibitors used to treated HIV infection * Cisapride * Grapefruit juice * Diltiazem * Tacrolimus * Hypericum perforatum (St. John's wort) * Barbiturates * Rifampin * Phenobarbital * Rifabutin * Efavirenz * Nevirapine * At least 7 days since prior herbal medicines and medications, including any of the following: * Hydrastis canadensis (goldenseal) * Uncaria tomentosa (cat's claw) * Echinacea angustifolia roots * Trifolium pretense (wild cherry) * Chamomile * Glycyrrhiza glabra (licorice) * Dillapiol * Naringenin * Norfloxacin * Atorvastatin * Pravastatin * Cimetidine * Fluconazole
References
Publications (1)
- RESULTArmstrong AJ, Netto GJ, Rudek MA, Halabi S, Wood DP, Creel PA, Mundy K, Davis SL, Wang T, Albadine R, Schultz L, Partin AW, Jimeno A, Fedor H, Febbo PG, George DJ, Gurganus R, De Marzo AM, Carducci MA. A pharmacodynamic study of rapamycin in men with intermediate- to high-risk localized prostate cancer. Clin Cancer Res. 2010 Jun 1;16(11):3057-66. doi: 10.1158/1078-0432.CCR-10-0124. Epub 2010 May 25. PMID 20501622