Phase 2
Completed N=42
Neoadjuvant Bevacizumab Plus Docetaxel in High Risk Patients With Prostate Cancer Undergoing Radical Prostatectomy
Source: ClinicalTrials.gov NCT00321646 ↗Enrolled (actual)
42
Serious AEs
26.8%
Results posted
Dec 2013
Primary outcomePrimary: Endorectal MRI Response After Completion of 6 Cycles of Neoadjuvant Therapy — 0.29 proportion of participants
Summary
The main purpose of this trial is to collect information and to evaluate the effects, good or bad, the combination of docetaxel and bevacizumab has on patients with high risk prostate cancer that are undergoing radical prostatectomy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Endorectal MRI Response After Completion of 6 Cycles of Neoadjuvant Therapy |
0.29 | — |
| SECONDARY PSA Response After Completing 6 Cycles of Neoadjuvant Chemotherapy. |
0.22 | — |
Eligibility Criteria
Inclusion Criteria
- Histological documentation of adenocarcinoma of the prostate, with available biopsy pathology. Material from this biopsy must be available for central review at DF/HCC by the beginning of the second cycle of therapy.
- Potential candidate for radical prostatectomy
- Must meet one or more of the below characteristics: Gleason score of 8, 9 or 10; serum PSA of greater than or equal to 20 ng/mL; clinical T stage of T3; PSA velocity of greater than or equal to 2ng/mL/year in the year prior to diagnosis; Gleason score of 7 and erMRI T3 disease; Greater than or equal to 50% of the total number of biopsy cores positive for prostate cancer and either PSA > 10ng/mL or Gleason score of 7 or clinical T stage of T2a, T2b or T2c.
- Greater than six weeks since any major surgery
- Serum testosterone > 100ng/dL
- ECOG Performance Status of 0 or 1
- ANC > 1,500/ul
- Platelets > 100,000/ul
- Total bilirubin, alkaline phosphatase, AST and ALT within normal limits
- Creatinine 1.0 at screening.
Data sourced from ClinicalTrials.gov (NCT00321646). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.