Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy
This study is ongoing, but not recruiting participants.
Sponsor:
Dana-Farber Cancer Institute
Collaborators:
Genentech, Inc.
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Rutgers Cancer Institute of New Jersey
Information provided by (Responsible Party):
Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00776594
First received: October 20, 2008
Last updated: July 13, 2016
Last verified: July 2016
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: Androgen Deprivation Therapy Drug: bicalutamide Drug: bevacizumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Phase II Trial of Short-Course Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy |
Resource links provided by NLM:
Further study details as provided by Dana-Farber Cancer Institute:
Primary Outcome Measures:
- Relapse-free Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]To identify a difference in relapse-free survival in men treated with short course ADT (6 months) versus short course ADT plus bevacizumab.
Secondary Outcome Measures:
- Number of Participants With PSA <0.2 ng/ml at Six Months [ Time Frame: Six months (at completion of treatment) ] [ Designated as safety issue: No ]Number of participants with a PSA <0.2 ng/ml at six months (upon completion of treatment).
- Cardiovascular Safety Including Measurement of Blood Pressure During Treatment Period (6 Months). [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]The number of patients who developed hypertension (greater that 150 systolic or greater than 90 diastolic) during treatment period.
- Analysis of Cytokines and Angiogenic Factors in Plasma/Serum [ Time Frame: 6 months ] [ Designated as safety issue: No ]Analysis of cytokines and angiogenic factors in plasma/serum at baseline and at 6 months (end of treatment).
| Enrollment: | 102 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | December 2016 |
| Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
Androgen Deprivation Therapy Plus Bevacizumab
|
Drug: Androgen Deprivation Therapy
leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months
Other Name: ADT
Drug: bicalutamide
50mg orally daily for 6 months
Drug: bevacizumab
15mg/ks given IV every three weeks for a total of 8 infusions over 6 months
|
|
Experimental: Group 2
Androgen Deprivation Therapy Alone
|
Drug: Androgen Deprivation Therapy
leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months
Other Name: ADT
Drug: bicalutamide
50mg orally daily for 6 months
|
Detailed Description:
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00776594
Please refer to this study by its ClinicalTrials.gov identifier: NCT00776594
Locations
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21205 | |
| United States, Massachusetts | |
| Beth-Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02115 | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201 | |
| United States, New Jersey | |
| Cancer Institute of New Jersey | |
| New Brunswick, New Jersey, United States, 08901 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| United States, Texas | |
| The University of Texas M D Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| United States, Wisconsin | |
| University of Wisconsin Carbone Cancer Center | |
| Madison, Wisconsin, United States, 53792-5669 | |
Sponsors and Collaborators
Dana-Farber Cancer Institute
Genentech, Inc.
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Rutgers Cancer Institute of New Jersey
Investigators
| Principal Investigator: | Mary-Ellen Taplin, MD | Dana-Farber Cancer Institute |
More Information
| Responsible Party: | Mary-Ellen Taplin, MD, Associate Professor of Medicine, HMS, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00776594 History of Changes |
| Obsolete Identifiers: | NCT01019031 |
| Other Study ID Numbers: | 08-190 |
| Study First Received: | October 20, 2008 |
| Results First Received: | July 29, 2015 |
| Last Updated: | July 13, 2016 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Dana-Farber Cancer Institute:
|
Androgen deprivation therapy ADT bevacizumab |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Recurrence Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Disease Attributes Pathologic Processes Bevacizumab Bicalutamide Methyltestosterone Ascorbic Acid Androgens |
Estrogens, Conjugated (USP) Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Vitamins Micronutrients Estrogens |
ClinicalTrials.gov processed this record on September 30, 2016