Prostate CancerPhase 2NCT00771017
Androgen Ablation Therapy With or Without Vaccine Therapy in Treating Patients With Prostate Cancer
A Phase 2 study testing GVAX prostate cancer vaccine, bicalutamide and goserelin in people with Prostate Cancer, run by Eastern Cooperative Oncology Group.
Trial summary
RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation therapy, such as bicalutamide, leuprolide, and goserelin, may lessen the amount of androgens made by the body. Vaccine therapy may help the body build an effective immune response to kill tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 120 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- GVAX prostate cancer vaccine, bicalutamide and goserelin
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2008to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 120 years
- Men only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- Biochemically relapsed prostate cancer
- Must have received primary therapy (i.e., radical prostatectomy, definitive radiotherapy, brachytherapy, or cryotherapy)
- If patient has a rising PSA after radical prostatectomy, salvage radiotherapy must have been offered
- Evidence of biochemical progression as determined by 3 PSA measurements, each higher than the previous value and meeting the following criteria:
- The second PSA (PSA2) must be obtained at least 8 weeks after the first (PSA1)
- The third PSA (PSA3) must be obtained at least 2 weeks after the PSA2 and within the past 4 weeks
- The PSA3 must be > 2.0 ng/mL and ≤ 20 ng/mL
- Must not have received more than 1 course of prior androgen ablation, defined as treatment with a luteinizing hormone-releasing hormone agonist resulting in a castrate testosterone level AND a PSA nadir ≤ 0.1 followed by subsequent withdrawal of androgen ablation and recovery of testosterone to a non-castrate level
- No evidence of metastatic disease on radionuclide bone scan and CT scan performed within the past 8 weeks
- Retroperitoneal lymphadenectomy ≤ 2 cm is not considered metastatic for purposes of this study
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- WBC > 2,500/mm³
- ANC ≥ 1,500/mm³
- Hemoglobin > 9.0 g/dL
- Platelet count ≥ 100,000/mm³
- Serum creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 60 mL/min
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 2.5 times ULN
- PT/INR ≤ 1.3
- Serum testosterone normal
- Fertile patients must use effective contraception
- No active autoimmune disease or history of autoimmune disease requiring treatment with systemic immunosuppression including, but not limited to, any of the following:
- Inflammatory bowel disease
- Systemic lupus erythematosus
- Systemic vasculitis
- Scleroderma
- Multiple sclerosis
- Hemolytic anemia
- Sjögren syndrome
- Sarcoidosis
- No known active infection
- No uncontrolled concurrent illness including, but not limited to, any of the following:
- Systemic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness/social situations that would limit compliance with study requirements
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to leuprolide acetate, bicalutamide, or sargramostim (GM-CSF)
- No known sensitivity to materials of bovine origin
- No hypersensitivity to GM-CSF or to any of the other components of CG1940/CG8711, which includes fetal bovine serum, dimethyl sulfoxide (DMSO), and hydroxyethyl starch and may include small amounts of porcine trypsin and DNase
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 4 weeks since prior and no concurrent systemic corticosteroids
- Use of inhaled corticosteroids for asthma or chronic obstructive pulmonary disease (COPD) is permitted
- More than 4 weeks since prior and no concurrent chemotherapy or other cancer therapy
- More than 4 weeks since prior and no concurrent use of herbal products (e.g., saw palmetto or PC-SPES)
- At least 4 weeks since prior and no other concurrent investigational agents
- No other concurrent anticancer commercial agents or therapies
- Prior androgen ablation administered concomitantly with primary radiotherapy allowed
About this study
Official title: A Randomized, Phase II Trial of Brief Androgen-Ablation Combined With Cell-based CG1940/CG8711 Immunotherapy For Prostate Cancer in Patients With Non-Metastatic, Biochemically Relapsed Prostate Cancer
RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation therapy, such as bicalutamide, leuprolide, and goserelin, may lessen the amount of androgens made by the body. Vaccine therapy may help the body build an effective immune response to kill tumor cells. It is not yet known whether androgen ablation therapy is more effective with or without vaccine therapy in treating patients with prostate cancer.
PURPOSE: This randomized phase II trial is studying androgen ablation therapy to see how well it works when given together with or without vaccine therapy in treating patients with prostate cancer.
Read the detailed description
OBJECTIVES:
Primary
- To determine the median PSA recurrence-free survival of patients with nonmetastatic, biochemically relapsed prostate cancer who respond with a PSA ≤ 0.5 ng/mL when administered a brief (6-month) course of androgen ablation either alone or in combination with GVAX prostate cancer vaccine (CG1940/CG8711) immunotherapy.
Secondary
- To determine the safety of combined treatment with androgen ablation and CG1940/CG8711 immunotherapy in these patients.
- To determine median time to metastatic disease development in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to Gleason score (> 7 vs ≤ 7), PSA doubling time (< 3 months vs 3-9 months vs > 9 months) and prior androgen ablation (yes vs no). Patients are randomized to 1 of 2 treatment arms at a 1 (arm I):2 (arm II) ratio.
- Arm I (androgen-ablation therapy): Patients receive oral bicalutamide once daily on days 1-28. Patients also receive luteinizing hormone-releasing hormone (LHRH) agonist treatment comprising leuprolide acetate or goserelin intramuscularly (IM) on day 8. Treatment with LHRH agonist repeats every 12 weeks for 24 weeks.
- Arm II (androgen-ablation therapy and vaccine): Patients receive androgen ablation as in arm I. Patients also receive GVAX prostate cancer vaccine (CG1940 and CG8711) intradermally (ID) on day 1. Beginning on day 1 of week 3, patients receive booster doses of CG1940 and CG8711 ID every 2 weeks for 24 weeks.
Patients are evaluated on day 1 of week 25 to assess disease. If PSA > 0.5 ng/mL AND there is no evidence of metastatic disease on imaging studies, then patients can be treated at the discretion of the investigator. If PSA ≤ 0.5 ng/mL, and there is no evidence of metastatic disease, then patients are considered responders and continue having PSA evaluated every 4 weeks until PSA relapse.
After completion of study therapy, patients are followed periodically for 5 years and then annually thereafter.
- Conditions
- Prostate Cancer
- Being tested
- GVAX prostate cancer vaccine, bicalutamide, goserelin, leuprolide acetate
- Keywords
- adenocarcinoma of the prostate, recurrent prostate cancer, stage II prostate cancer, stage III prostate cancer, stage I prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GVAX prostate cancer vaccineBiological
Given intradermally
bicalutamideDrug
Given orally
goserelinDrug
Given intramuscularly
leuprolide acetateDrug
Given intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Active comparator | Patients receive oral bicalutamide once daily on days 1-28. Patients also receive luteinizing-hormone releasing-hormone (LHRH) agonist treatment comprising leuprolide acetate or goserelin intramuscularly (IM) on day 8. Treatment with LHRH agonist repeats every 12 weeks for 24 weeks. Receives: Drug: bicalutamide; Drug: goserelin; Drug: leuprolide acetate |
| Arm II | Experimental | Patients receive androgen ablation as in arm I. Patients receive GVAX prostate cancer vaccine (CG1940 and CG8711) intradermally (ID) on day 1. Beginning on day 1 of week 3, patients receive booster doses of CG1940 and CG8711 ID every 2 weeks for 24 weeks. Receives: Biological: GVAX prostate cancer vaccine; Drug: bicalutamide; Drug: goserelin; Drug: leuprolide acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median PSA recurrence-free survival in patients in patients responding to the study treatments
Secondary outcomes (3)
Safety
Effects of 6-month androgen ablation on thymic production of naïve T cells
Median time to metastatic disease development
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2008 (estimated)
- Study startJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Cooperative Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Charles G. Drake, MD, PhD, Study chair, Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsMichael A. Carducci, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00771017
- Sponsor's protocol ID
- CDR0000616570
- Other IDs
- ECOG-E3806
- Status last verified
- May 2023
- First submitted
- 9 Oct 2008
- Last updated
- 25 May 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase II Trial of Brief Androgen-Ablation Combined With Cell-based CG1940/CG8711 Immunotherapy For Prostate Cancer in Patients With Non-Metastatic, Biochemically Relapsed Prostate Cancer
- ClinicalTrials.gov ID
- NCT00771017
- Acronym / sponsor ID
- CDR0000616570
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, recurrent prostate cancer, stage II prostate cancer, stage III prostate cancer, stage I prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eastern Cooperative Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2008
- First posted
- 10 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation therapy, such as bicalutamide, leuprolide, and goserelin, may lessen the amount of androgens made by the body. Vaccine therapy may help the body build an effective immune response to kill tumor cells. It is not yet known whether androgen ablation therapy is more effective with or without vaccine therapy in treating patients with prostate cancer.
PURPOSE: This randomized phase II trial is studying androgen ablation therapy to see how well it works when given together with or without vaccine therapy in treating patients with prostate cancer.
Detailed description
OBJECTIVES:
Primary
- To determine the median PSA recurrence-free survival of patients with nonmetastatic, biochemically relapsed prostate cancer who respond with a PSA ≤ 0.5 ng/mL when administered a brief (6-month) course of androgen ablation either alone or in combination with GVAX prostate cancer vaccine (CG1940/CG8711) immunotherapy.
Secondary
- To determine the safety of combined treatment with androgen ablation and CG1940/CG8711 immunotherapy in these patients.
- To determine median time to metastatic disease development in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to Gleason score (> 7 vs ≤ 7), PSA doubling time (< 3 months vs 3-9 months vs > 9 months) and prior androgen ablation (yes vs no). Patients are randomized to 1 of 2 treatment arms at a 1 (arm I):2 (arm II) ratio.
- Arm I (androgen-ablation therapy): Patients receive oral bicalutamide once daily on days 1-28. Patients also receive luteinizing hormone-releasing hormone (LHRH) agonist treatment comprising leuprolide acetate or goserelin intramuscularly (IM) on day 8. Treatment with LHRH agonist repeats every 12 weeks for 24 weeks.
- Arm II (androgen-ablation therapy and vaccine): Patients receive androgen ablation as in arm I. Patients also receive GVAX prostate cancer vaccine (CG1940 and CG8711) intradermally (ID) on day 1. Beginning on day 1 of week 3, patients receive booster doses of CG1940 and CG8711 ID every 2 weeks for 24 weeks.
Patients are evaluated on day 1 of week 25 to assess disease. If PSA > 0.5 ng/mL AND there is no evidence of metastatic disease on imaging studies, then patients can be treated at the discretion of the investigator. If PSA ≤ 0.5 ng/mL, and there is no evidence of metastatic disease, then patients are considered responders and continue having PSA evaluated every 4 weeks until PSA relapse.
After completion of study therapy, patients are followed periodically for 5 years and then annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Active comparator | Drug: bicalutamide, Drug: goserelin, Drug: leuprolide acetatePatients receive oral bicalutamide once daily on days 1-28. Patients also receive luteinizing-hormone releasing-hormone (LHRH) agonist treatment comprising leuprolide acetate or goserelin intramuscularly (IM) on day 8. Treatment with LHRH agonist repeats every 12 weeks for 24 weeks. |
| Arm II | Experimental | Biological: GVAX prostate cancer vaccine, Drug: bicalutamide, Drug: goserelin, Drug: leuprolide acetatePatients receive androgen ablation as in arm I. Patients receive GVAX prostate cancer vaccine (CG1940 and CG8711) intradermally (ID) on day 1. Beginning on day 1 of week 3, patients receive booster doses of CG1940 and CG8711 ID every 2 weeks for 24 weeks. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| GVAX prostate cancer vaccineGiven intradermally | Biological | Arm II |
| bicalutamideGiven orally | Drug | Arm I, Arm II |
| goserelinGiven intramuscularly | Drug | Arm I, Arm II |
| leuprolide acetateGiven intramuscularly | Drug | Arm I, Arm II |
Primary outcome
Median PSA recurrence-free survival in patients in patients responding to the study treatments
3 secondary outcomes
Safety
Effects of 6-month androgen ablation on thymic production of naïve T cells
Median time to metastatic disease development
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
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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.
Charles G. Drake, MD, PhD study chair
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Michael A. Carducci, MD
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GVAX prostate cancer vaccine, bicalutamide and goserelin in people with Prostate Cancer, run by Eastern Cooperative Oncology Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Median PSA recurrence-free survival in patients in patients responding to the study treatments. 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 25 May 2023; AzTrials last refreshed its copy on 6 Nov 2026.