Clinical trial · Interventional
Study of OGX-011 Given Prior to Radical Prostatectomy in Patients With Localized Prostate Cancer
A Phase II Study of OGX-011 Given Prior to Radical Prostatectomy in Patients With Localized Prostate Cancer
NCT00138918CI-TRIAL-00026246completedPhase 2ClinicalTrials.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)
The purpose of this trial is to assess the effects of combined therapy with androgen ablation and OGX-011 (an antisense to clusterin) given prior to radical prostatectomy on pathologic complete response rates in men with localized prostate cancer and high risk features.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OGX-011 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To assess the effects of combined neoadjuvant hormone therapy (NHT) and OGX-011 prior to radical prostatectomy on pathologic complete response rates in men with high risk localized prostate cancer
- timeFrame
- See Detailed Description, Treatment Plan
Secondary outcomes (7)
- measure
- To quantify changes in clusterin expression in residual prostate cancer after treatment with NHT and OGX-011
- timeFrame
- See Detailed Description, Treatment Plan
- measure
- To measure levels of full length OGX-011 in prostate tissues after 3 months of NHT
- timeFrame
- See Detailed Description, Treatment Plan
- measure
- To assess the safety and tolerability toxicity of 3 months of OGX-011 and NHT prior to radical prostatectomy
- timeFrame
- See Detailed Description, Treatment Plan
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed adenocarcinoma of the prostate, previously untreated 2. Males ≥ 18 years of age. 3. Potential candidate for radical prostatectomy 4. Any of the following (minimum of 2 positive biopsies): * Clinical stage T3 * Serum PSA \> 10 ng/ml * Gleason score 7-10 * Gleason score 6 and \> 3 positive biopsies 5. ECOG performance status 0-1 6. WBC ≥ 3.0 x 10\^9/L 7. Hemoglobin ≥ 100 g/L 8. Platelets ≥ 100 x 10\^9/L 9. PTT, INR, AST, ALT, creatinine, total bilirubin within normal limits 10. Patients must sign an informed consent that complies with US Regulations (US 21 Code of Federal Regulations \[CFR\]) and the International Conference on Harmonization (ICH) Guideline for Good Clinical Practice (GCP) prior to undergoing treatment. Exclusion Criteria: 1. Prior hormone, radiation, or chemotherapy for prostate cancer 2. Evidence of active infection 3. Patients receiving therapeutic doses of warfarin or heparin 4. Severe end organ disease 5. Patients who otherwise would not be candidates for radical prostatectomy because of health or tumour factors 6. Patients will be excluded if they had any prior malignancy unless the prior malignancy was diagnosed and definitively treated at least five years previously and there has never been any evidence of recurrence. 7. Other serious illness, psychiatric, or medical condition that would not permit the patient to be managed according to the protocol.
References
Publications (0)
Data not yet available
No reference posted for this study.