Clinical trial NCT00658697
Conditions: Prostate Cancer
Keywords: Rising PSA androgen deprivation bevacizumab (avastin) docetaxel lupron zoladex bicalutamide
Sponsor: Dana-Farber Cancer Institute
Start date: 2008-06-01; Completion date: 2015-06-01
Enrollment: 42 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
In this research study, we aim to evaluate the feasibility, toxicity and efficacy of early multimodality systemic therapy (a combination of docetaxe, bevacizumab, and androgen deprivation therapy(ADT) in men with biochemical recurrence (BCR) or who have a rising Prostate Specific Antigen (PSA) after treatment of their prostate cancer with surgery or radiation)

Detailed description:
A single arm phase 2 study designed to evaluate the rate of patients free from Prostate Specific Antigen (PSA) progression (TTP) one year after completing ADT for men with BCR after definitive local therapy for prostate cancer.

The null and alternative TTP rate were 41% and 60% respectively. A sample size of 42 would provide 80% power to detect the difference with a 2-sided type I error rate of 0.05.'

The primary objective was to evaluate the proportion of patients free from PSA progression after completing one year of ADT

The secondary objectives included

1. PSA response (\< 0.2 ng/mL and \< 0.01) at completion of docetaxel/bevacizumab, at completion of ADT and one year off ADT
2. Correlation of PSA response and TTP
3. Toxicity
4. Testosterone recovery at 6, 12 months off ADT

Treatment schedule details are as follows:

* Each treatment cycle lasts three weeks. During the first three months, participants will receive the Avastin and docetaxel on day 1 of each three-week cycle for a total of four doses of docetaxel/Avastin. Avastin and docetaxel are administered intravenously. The Avastin will continue to be given every three weeks after the docetaxel is completed for a total of 17 doses (one year) of Avastin therapy.
* Participants will receive zoladex (or lupron) on day 1 of the first cycle and then every 3 months for a total of 18 months. Zoladex is administered subcutaneously and Lupron is administered intramuscularly.
* Bicalutamide pills will be started at the completion of docetaxel chemotherapy (start of month 4) and will be taken once daily until hormone therapy is completed (total of 15 months).
* During all treatment cycles, the participant will have a physical exam and will be asked questions about their general health and specific questions about any problems they might be experiencing. Blood work will be performed every three weeks for the first three months and then every three months while on hormone therapy and during follow-up.
* After the final treatment participants will have a follow-up visit every three months for the first two years, every 4 months for the third year and every 6 months for years 4 and 5.

Arms: arm 1: Docetaxel:

Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles

Bevacizumab:

Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles

ADT or Luteinizing hormone-releasing hormone agonist (LHRH):

Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months)

Bicalutamide:

Oral Bicalutamide on day 84 once daily (after completing docetaxel, at 3 month) at dose of 50 mg for a total 15 months (4-18 months)
Interventions: intervention 1: Docetaxel intervention 2: Bevacizumab intervention 3: ADT intervention 4: Bicalutamide
Intervention descriptions: intervention 1: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles intervention 2: Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles intervention 3: Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months) intervention 4: Starting on day 84 orally once daily until hormone therapy is completed

Protocol documents: