| October 20, 2008 |
| December 16, 2008 |
| October 2008 |
| September 2010 (final data collection date for primary outcome measure) |
| To identify a difference in relapse-free survival in men treated with short course ADT (6 months) versus short course ADT plus bevacizumab. [ Time Frame: 2 years ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00776594 on ClinicalTrials.gov Archive Site |
- Percent of patient PSA <0.2 ng/ml at six months [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Cardiovascular safety including baseline and post therapy measurement of blood pressure, lipid profiles. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Analysis of cytokines and angiogenic factors in plasma/serum [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy |
| Randomized Phase II Trial of Short-Course Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy |
The purpose of this research study is to assess the efficacy of antiangiogenic therapy (bevacizumab) and androgen deprivation versus androgen deprivation alone at the time of minimal systemic disease (based on rising PSA without metastases). |
- Participants will be randomized into one of two study groups. The first group will receive Androgen Deprivation Therapy (ADT) plus bevacizumab. The second group will receive ADT alone.
- For the Androgen Deprivation therapy either (treating physician discretion)leuprolide or goserelin acetate (given as injections) every 3 months for a total of 6 months. Bicalutamide will also be taken orally daily for a total of 6 months.
- Bevacizumab will be given intravenously every three weeks for a total of 8 infusions over 6 months.
- Participants will be evaluated every 7-9 weeks with vitals, physical exam, PS, laboratories including PSA and testosterone.
|
| Phase II |
| Interventional |
| Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Prostate Cancer |
- Drug: Androgen Deprivation Therapy
- Drug: bicalutamide
- Drug: bevacizumab
|
- Experimental: Androgen Deprivation Therapy Plus Bevacizumab
- Experimental: Androgen Deprivation Therapy Alone
|
| |
| |
| Recruiting |
| 100 |
|
| September 2010 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- History of biopsy documented prostate cancer (any Gleason score)
- Past treatment with prostatectomy with or without salvage prostate/pelvic radiation or primary radiation (external beam or brachytherapy)
- If past prostatectomy, pathologic stage no greater than T1-3, N1, M0
- PSA recurrence with PSAdt < 18 months. There is no minimum PSA for prostatectomy patients. For patients treated with primary radiation therapy PSA should be greater than 2.0 ng/ml
- No evidence of recurrent disease on exam, bone scan, CT/MRI abdomen/pelvis or CXR
- Prior ADT allowed if < 6 months and testosterone recovered to within 50 units (ng/dl) of normal range
- ECOG Performance status of 0-1
- Absolute neutrophil count of >1,500
- Platelet count > 100,000
- Hg > 8g/dl
- No history of bleeding or thromboses within the last 12 months that required medical intervention
Exclusion Criteria:
- History of cancer within 5 years, other than prostate cancer and non-melanoma skin cancer
- Medical condition requiring concomitant corticosteroids
- Active infection
- Prior chemotherapy allowed if was < 6 cycles and > 6 months prior to study entry
- Documented local recurrence or metastatic prostate cancer
- Inability to comply with study and/or follow-up procedures
- Life expectancy of less than 2 years
- Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
|
| Male |
| 18 Years and older |
| No |
| Contact: Mary-Ellen Taplin, MD |
617-632-5092 |
|
|
| Contact: Peggy Inman |
617-632-4420 |
|
|
|
| United States |
| |
| NCT00776594 |
| Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute |
| 08-190 |
| Dana-Farber Cancer Institute |
- Genentech
- Beth Israel Deaconess Medical Center
- Brigham and Women's Hospital
|
| Principal Investigator: |
Mary-Ellen Taplin, MD |
Dana-Farber Cancer Institute |
|
|
| Dana-Farber Cancer Institute |
| December 2008 |