Enzalutamide in Combination With PSA-TRICOM in Patients With Non-Metastatic Castration Sensitive Prostate Cancer
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ClinicalTrials.gov Identifier: NCT01875250 |
Recruitment Status :
Completed
First Posted : June 11, 2013
Results First Posted : September 16, 2020
Last Update Posted : September 16, 2020
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Tracking Information | |||||
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First Submitted Date ICMJE | June 7, 2013 | ||||
First Posted Date ICMJE | June 11, 2013 | ||||
Results First Submitted Date ICMJE | August 13, 2020 | ||||
Results First Posted Date ICMJE | September 16, 2020 | ||||
Last Update Posted Date | September 16, 2020 | ||||
Actual Study Start Date ICMJE | July 22, 2013 | ||||
Actual Primary Completion Date | September 1, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Tumor Growth Rate [ Time Frame: 7 months ] Growth rate was measured using the growth rate equation -f(t) = exp (-d*t) + exp (g*t) -1 where exp is the base of the natural algorithm, e = 2.7182 and t is days since treatment started. The tumor growth rate equation measures Prostate Specific Antigen (PSA) rise over time. The UOM is unitless because this is a way to measure PSA kinetics.
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Original Primary Outcome Measures ICMJE |
Decrease in tumor re-growth rate [ Time Frame: 3 years ] | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Enzalutamide in Combination With PSA-TRICOM in Patients With Non-Metastatic Castration Sensitive Prostate Cancer | ||||
Official Title ICMJE | A Phase II Trial of Enzalutamide in Combination With PSA-TRICOM in Patients With Non-Metastatic Castration Sensitive Prostate Cancer | ||||
Brief Summary | Background: - Enzalutamide is a well tolerated hormone therapy that is used to treat advanced prostate cancer. It is given to help kill cancer cells and limit cancer cell growth. A new possible way of treating prostate cancer is using a therapeutic cancer vaccine (immune stimulating therapy) that may help activate the immune system against the cancer. The immune stimulating vaccine will help white blood cells recognize and kill the cancer cells throughout the body. This vaccine therapy has been tested in hundreds of patients and is very well tolerated. Researchers want to see whether this vaccine, given with enzalutamide, is more effective at treating advanced prostate cancer than enzalutamide alone. Objectives: - To compare the safety and effectiveness of enzalutamide with and without vaccine therapy for advanced prostate cancer. Key Eligibility:
Design:
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Detailed Description | Background:
Objectives: Primary Endpoint: -Determine if PSA-TRICOM combined with the novel androgen receptor antagonist enzalutamide will result in a decrease in PSA growth kinetics (tumor re-growth rate) after enzalutamide discontinuation in patients with non-metastatic, castration sensitive prostate cancer (i.e. patients with normal testosterone). Eligibility:
Design:
Cohort 1:
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Prostate Cancer | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
38 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | February 28, 2020 | ||||
Actual Primary Completion Date | September 1, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
A. Histopathological documentation of prostate cancer confirmed in the Laboratory of Pathology at the National Institutes of Health (NIH) Clinical Center, or Walter Reed National Military Medical Center prior to enrollment. If no pathologic specimen is available, patients may enroll with a pathologists report showing a histologic diagnosis of prostate cancer and a clinical course consistent with the disease. B. Biochemical progression defined as follows:
C. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (Karnofsky greater than or equal to 80%). D. Patients must have a PSA doubling time of 12 months or less. E. Patients must have a rising PSA as confirmed by 3 values done at least 1 week apart and over no less than 1 month. F. Recovery from acute toxicity related to prior therapy, including surgery and radiation, or no toxicity greater than or equal to grade 2. G. Negative computed tomography (CT) scan/magnetic resonance imaging (MRI) and bone scan for metastatic prostate cancer. H. Hematological eligibility parameters (within 16 days before starting therapy): Granulocyte count greater than or equal to 1000/mm(3) Platelet count greater than or equal to 100,000/mm(3) Hemoglobin (Hgb) greater than or equal to 10 g/dL I. Biochemical eligibility parameters (within 16 days before starting therapy): Hepatic function: bilirubin less than or equal to 1.5 mg/dL (OR in patients with Gilbert's syndrome, a total bilirubin less than or equal to 3.0), aspartate transaminase (AST) and alanine transaminase (ALT) less than or equal to 2.5 times upper limit of normal. J. No other active malignancies within the past 36 months (with the exception of nonmelanoma skin cancers or carcinoma in situ of the bladder) or life-threatening illnesses K. Willing to travel to the National Institutes of Health (NIH) for follow-up visits. L. 18 years of age or older. M. Able to understand and sign informed consent. N. Baseline testosterone greater than or equal to lower limit of normal. O. PSA less than or equal to 20 ng/mL. P. The effects of enzalutamide, PSA-TRICOM or the combination on the developing human fetus are unknown. For this reason, men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately. EXCLUSION CRITERIA: A. Immunocompromised status due to:
B. Chronic administration (defined as daily or every other day for continued use greater than 14 days) of corticosteroids deemed systemic by investigator within 28 days before the first planned dose of PSA-TRICOM. Use of inhaled steroids, nasal sprays, and topical creams for small body areas is allowed. C. Serious intercurrent medical illness that, in the judgment of the investigator, would interfere with patient's ability to carry out the treatment program. D. History of seizure, including any febrile seizure, loss of consciousness, or transient ischemic attack, or any condition that may pre-dispose to seizure (e.g., prior stroke, brain arteriovenous malformation, head trauma with loss of consciousness requiring hospitalization). E. Other medications used for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (eg phytoestrogens and saw palmetto) F. History of prior chemotherapy G. History of prior immunotherapy within the last 3 years H. Major surgery within 4 weeks prior to enrollment (Day 1 visit). I. History of allergic reactions attributed to compounds of similar chemical or biologic composition to enzalutamide or poxviral vaccines (e.g., vaccinia vaccine) J. Known allergy to eggs, egg products, aminoglycoside antibiotics (for example, gentamicin or tobramycin). K. History of atopic dermatitis or active skin condition (acute, chronic, exfoliative) that disrupts the epidermis L. Previous serious adverse reactions to smallpox vaccination M. Unable to avoid close contact or household contact with the following highrisk individuals for three weeks after the Day 1 vaccination: (a) children 3 years of age, (b) pregnant or nursing women, (c) individuals with prior or concurrent extensive eczema or other eczematoid skin disorders, or (d) immunocompromised individuals, such as those with human immunodeficiency virus (HIV). N. Receipt of an investigational agent within 30 days (or 60 days for an antibody based therapy) before the first planned dose of study drugs. O. Patients who test positive for Hepatitis B virus (HBV) or hepatitis C virus (HCV) P. Use of herbal products that may decrease PSA levels (e.g. saw palmetto) Q. Any gastrointestinal disease that could hinder the absorption of enzalutamide R. Uncontrolled hypertension (Systolic Blood Pressure (SBP)>170/ Diastolic Blood Pressure (DBP)>105) |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 100 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT01875250 | ||||
Other Study ID Numbers ICMJE | 130153 13-C-0153 |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Ravi A. Madan, M.D., National Cancer Institute (NCI) | ||||
Original Responsible Party | National Cancer Institute (NCI) | ||||
Current Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | National Institutes of Health Clinical Center (CC) | ||||
Verification Date | September 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |