Prostate CancerPhase 2NCT00776594
Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy
A Phase 2 study testing Androgen Deprivation Therapy, bicalutamide and bevacizumab in people with Prostate Cancer, run by Dana-Farber Cancer Institute at 8 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Androgen Deprivation Therapy, bicalutamide and bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 8 sitesUnited States
- Study dates
- Oct 2008to Sep 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Johns Hopkins University
Baltimore, Maryland, 21205
Beth-Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Karmanos Cancer Institute
Detroit, Michigan, 48201
The University of Texas M D Anderson Cancer Center
Houston, Texas, 77030
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792-5669
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
Official title: 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).
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Androgen Deprivation Therapy, bicalutamide, bevacizumab
- Keywords
- Androgen deprivation therapy, ADT, bevacizumab
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Androgen Deprivation TherapyDrug
Also called ADT
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
bicalutamideDrug
50mg orally daily for 6 months
bevacizumabDrug
15mg/ks given IV every three weeks for a total of 8 infusions over 6 months
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Androgen Deprivation Therapy Plus Bevacizumab Receives: Drug: Androgen Deprivation Therapy; Drug: bicalutamide; Drug: bevacizumab |
| Group 2 | Experimental | Androgen Deprivation Therapy Alone Receives: Drug: Androgen Deprivation Therapy; Drug: bicalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-free Survival
To identify a difference in relapse-free survival in men treated with short course ADT (6 months) versus short course ADT plus bevacizumab.
Measured: 2 years
Secondary outcomes (3)
Number of Participants With PSA <0.2 ng/ml at Six Months
Number of participants with a PSA <0.2 ng/ml at six months (upon completion of treatment).
Measured: Six months (at completion of treatment)
Cardiovascular Safety Including Measurement of Blood Pressure During Treatment Period (6 Months).
The number of patients who developed hypertension (greater that 150 systolic or greater than 90 diastolic) during treatment period.
Measured: 6 months
Analysis of Cytokines and Angiogenic Factors in Plasma/Serum
Analysis of cytokines and angiogenic factors in plasma/serum at baseline and at 6 months (end of treatment).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2014
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc., Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Rutgers Cancer Institute of New Jersey
- Responsible party
- Principal investigator, Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute
- Investigators
- Mary-Ellen Taplin, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00776594
- Sponsor's protocol ID
- 08-190
- Status last verified
- Sep 2016
- First submitted
- 20 Oct 2008
- Last updated
- 21 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial of Short-Course Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy
- ClinicalTrials.gov ID
- NCT00776594
- Acronym / sponsor ID
- 08-190
- Conditions
- Prostate Cancer
- Keywords
- Androgen deprivation therapy, ADT, bevacizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Genentech, Inc., Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Rutgers Cancer Institute of New Jersey
- Study start
- Oct 2008
- Primary completion
- Dec 2014 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 21 Oct 2008 (estimated)
- Results
- Posted 23 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Androgen Deprivation Therapy, Drug: bicalutamide, Drug: bevacizumabAndrogen Deprivation Therapy Plus Bevacizumab |
| Group 2 | Experimental | Drug: Androgen Deprivation Therapy, Drug: bicalutamideAndrogen Deprivation Therapy Alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Androgen Deprivation TherapyAlso: ADTleuprolide: 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 | Drug | Group 1, Group 2 |
| bicalutamide50mg orally daily for 6 months | Drug | Group 1, Group 2 |
| bevacizumab15mg/ks given IV every three weeks for a total of 8 infusions over 6 months | Drug | Group 1 |
Primary outcome
Relapse-free Survival
Time frame: 2 years
To identify a difference in relapse-free survival in men treated with short course ADT (6 months) versus short course ADT plus bevacizumab.
3 secondary outcomes
Number of Participants With PSA <0.2 ng/ml at Six Months
Time frame: Six months (at completion of treatment)
Cardiovascular Safety Including Measurement of Blood Pressure During Treatment Period (6 Months).
Time frame: 6 months
Analysis of Cytokines and Angiogenic Factors in Plasma/Serum
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary-Ellen Taplin, MD principal investigator
Dana-Farber Cancer Institute
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Androgen Deprivation Therapy, bicalutamide and bevacizumab in people with Prostate Cancer, run by Dana-Farber Cancer Institute at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse-free Survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2016.