A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer (Prospect)
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| ClinicalTrials.gov Identifier: NCT01322490 |
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Recruitment Status :
Completed
First Posted : March 24, 2011
Results First Posted : August 8, 2019
Last Update Posted : September 4, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prostate Cancer Metastatic | Biological: PROSTVAC-V Biological: PROSTVAC-F Drug: GM-CSF Other: GM-CSF Placebo Biological: Placebo | Phase 3 |
BNIT-PRV-301 is a randomized, placebo-controlled, multi-center, global Phase 3 efficacy trial of PROSTVAC in men with asymptomatic or minimally symptomatic, metastatic, castrate-resistant prostate cancer. It is a 3-arm study and will evaluate overall survival in two separate comparisons, PROSTVAC plus adjuvant dose GM-CSF versus controls, and PROSTVAC without GM-CSF versus controls.
Patients will be randomized with equal probability into one of three double-blind arms. The intended interventions for randomized patients are:
- (Arm V+G) PROSTVAC-V/F plus adjuvant dose GM-CSF
- (Arm V) PROSTVAC-V/F plus GM-CSF placebo
- (Arm P) Double placebo
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1297 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer |
| Actual Study Start Date : | November 28, 2011 |
| Actual Primary Completion Date : | September 25, 2017 |
| Actual Study Completion Date : | December 15, 2017 |
| Arm | Intervention/treatment |
|---|---|
Experimental: PROSTVAC-V/F-TRICOM + GM-CSF
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Biological: PROSTVAC-V Biological: PROSTVAC-F Drug: GM-CSF |
Experimental: PROSTVAC-V/F-TRICOM + GM-CSF placebo
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Biological: PROSTVAC-V Biological: PROSTVAC-F Other: GM-CSF Placebo |
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Placebo Comparator: Placebo Control
PROSTVAC V/F Placebo + GM-CSF Placebo
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Other: GM-CSF Placebo Biological: Placebo PROSTVAC V/F Placebo |
- Overall Survival [ Time Frame: Randomization through the date of death due to any cause. Subjects were followed up for approximately 6 years from the first subject randomized to the completion of the study. ]The time between the date of randomization and the date of death due to any cause. Subjects who did not experience death or the competing events of "definite" loss to follow-up or withdrawal of consent were right censored at the date of last contact. OS was calculated using the formula: OS = Date of death/competing event/censoring - date of randomization + 1.
- Number of Subjects Alive Without Event at 6 Months [ Time Frame: Randomization through Week 25/End of Treatment visit. ]
A binary assessment that was performed for the 6-months timepoint for the categories of radiographic progression, pain progression, initiation of chemotherapy or death. Subjects without an event prior to 6-months were evaluated at 6-months. Subjects without event by 6-months and were not evaluated at 6-months were assumed to have had an event and analyzed as such.
Progression events were defined as: (1) Two new lesions on bone scan, new metastases on CT scans, or an increased size of nodal lesions per RECIST 1.1. Bone or CT scans occurring prior to calendar month 6 were used to determine radiographic progression. (2) Introduction of scheduled opioid narcotics for cancer-related pain control. (3) Initiation of chemotherapy for prostate cancer was assessed as collected on progression forms as well as in cancer treatment and concomitant medications logs. (4) Death.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Men, ≥18years of age with documented asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer.
Documented progressive disease post surgical castration or during androgen suppression therapy, or during complete androgen blockade therapy and withdrawal. Documented by either criterion a (Radiological progression), OR criterion b (PSA progression).
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Radiological progression defined as any new/enlarging bone metastases or new/enlarging lymph node disease, consistent with prostate cancer.
OR
- PSA progression defined by sequence of rising values separated by > 1 week (2 separate increasing values) over a threshold minimum of 2.0 ng/ml. (PCWG2 PSA eligibility criteria).
Chemotherapy naïve and Vaccinia-experienced (previous smallpox vaccination). Currently using a GnRH agonist or antagonist (unless surgically castrated).
Exclusion Criteria:
Cancer-related pain requiring scheduled opioid narcotics for control (as needed, ≤ 2x per week is allowed).
Metastasis to organ systems other than lymph nodes and/or bone. Estimated PSA doubling time of <1 month as established within 6 months of the anticipated first dose of vaccine or placebo.
Concurrent or prior Provenge (sipuleucel-T) immunotherapy for prostate cancer. Receipt of an investigational agent within 30 days (or 60 days for an antibody-based therapy) of the first planned dose of PROSTVAC-V/F.
History of prior malignancies other than prostate cancer within the past 3 years, excluding successfully resected basal or squamous cell carcinoma of the skin.
Congestive heart failure (NYHA Class II, III, or IV), unstable angina, ventricular or hemodynamically significant atrial arrhythmia, or cardiovascular disease such as stroke or myocardial infarction (current or within the past 6 months) Confirmed positive for HIV, hepatitis B, and /or hepatitis C. Immunodeficiency or splenectomy. History of or active autoimmune disease, persons with vitiligo are not excluded. Diabetics are not excluded if the condition is well controlled.
History of atopic dermatitis or active skin condition (acute, chronic, exfoliative) that disrupts the epidermis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01322490
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| Principal Investigator: | James L. Gulley, MD | National Cancer Institute (NCI) | |
| Principal Investigator: | Philip Kantoff, MD | Dana-Farber Cancer Institute |
Documents provided by Bavarian Nordic:
| Responsible Party: | Bavarian Nordic |
| ClinicalTrials.gov Identifier: | NCT01322490 |
| Other Study ID Numbers: |
BNIT-PRV-301 |
| First Posted: | March 24, 2011 Key Record Dates |
| Results First Posted: | August 8, 2019 |
| Last Update Posted: | September 4, 2019 |
| Last Verified: | August 2019 |
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