Last reviewed · How we verify
Phase II PAP Plus GM-CSF Versus GM-CSF Alone for Non-metastatic Prostate Cancer
Phase 2 trial testing pTVG-HP in Prostate Cancer in 99 participants. Completed in 30 June 2020.
| Lead sponsor | University of Wisconsin, Madison |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 99 |
| Start date | 23 May 2011 |
| Primary completion | 30 June 2020 |
| Estimated completion | 30 June 2020 |
| Sites | 3 locations across United States |
University of Wisconsin, Madison
18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
2-year Metastasis-Free Survival (MFS) Rate with the development of metastases by conventional imaging used to define progression (as defined by RECIST 1.1 criteria). The 2-year MFS rate estimates which were obtained using the Kaplan-Meier analysis (taking into account censoring) using the intention-to-treat population.
| Group | Value | 95% CI |
|---|---|---|
| GM-CSF Alone | 42.3 | |
| pTVG-HP Vaccine With GM-CSF | 41.8 |
PSA DT was calculated using all serum PSA values available from the same clinical laboratory for the specified period by the equation log2/b where b denotes the least-squares estimator of the linear regression model of the log-transformed PSA values on time. Pretreatment PSA DT (3-6 months before treatment, with a minimum of 4 values), on-treatment PSA DT was determined using values from month 3 to month 9.
| Group | Value | 95% CI |
|---|---|---|
| GM-CSF Alone | 8.9 | 1.6 – 77.9 |
| pTVG-HP Vaccine With GM-CSF | 5.4 | 1.8 – 77.9 |
Number of participants who experienced any adverse events greater than grade 1 that were determined to be at least possibly related to treatment, highest grade reported per participant for each adverse event (AE). All toxicities were graded using National Cancer Institute Common Terminology Criteria for Adverse Events (version 4). Higher grades indicate more severe toxicities.
| Group | Value | 95% CI |
|---|---|---|
| GM-CSF Alone | 2 | |
| pTVG-HP Vaccine With GM-CSF | 1 | |
| GM-CSF Alone | 0 | |
| pTVG-HP Vaccine With GM-CSF | 0 | |
| GM-CSF Alone | 0 | |
| pTVG-HP Vaccine With GM-CSF | 0 | |
| GM-CSF Alone | 47 | |
| pTVG-HP Vaccine With GM-CSF | 47 |
| Group | Value | 95% CI |
|---|---|---|
| GM-CSF Alone | 2 | |
| pTVG-HP Vaccine With GM-CSF | 1 | |
| GM-CSF Alone | 0 | |
| pTVG-HP Vaccine With GM-CSF | 0 | |
| GM-CSF Alone | 0 | |
| pTVG-HP Vaccine With GM-CSF | 0 | |
| GM-CSF Alone | 47 | |
| pTVG-HP Vaccine With GM-CSF | 47 |
| Group | Value | 95% CI |
|---|---|---|
| GM-CSF Alone | 2 | |
| pTVG-HP Vaccine With GM-CSF | 2 | |
| GM-CSF Alone | 0 | |
| pTVG-HP Vaccine With GM-CSF | 0 | |
| GM-CSF Alone | 0 | |
| pTVG-HP Vaccine With GM-CSF | 0 | |
| GM-CSF Alone | 47 | |
| pTVG-HP Vaccine With GM-CSF | 46 |
| Group | Value | 95% CI |
|---|---|---|
| GM-CSF Alone | 0 | |
| pTVG-HP Vaccine With GM-CSF | 1 | |
| GM-CSF Alone | 0 | |
| pTVG-HP Vaccine With GM-CSF | 0 | |
| GM-CSF Alone | 0 | |
| pTVG-HP Vaccine With GM-CSF | 0 | |
| GM-CSF Alone | 49 | |
| pTVG-HP Vaccine With GM-CSF | 47 |
| Group | Value | 95% CI |
|---|---|---|
| GM-CSF Alone | 3 | |
| pTVG-HP Vaccine With GM-CSF | 0 | |
| GM-CSF Alone | 0 | |
| pTVG-HP Vaccine With GM-CSF | 1 | |
| GM-CSF Alone | 0 | |
| pTVG-HP Vaccine With GM-CSF | 0 | |
| GM-CSF Alone | 46 | |
| pTVG-HP Vaccine With GM-CSF | 47 |
| Group | Value | 95% CI |
|---|---|---|
| GM-CSF Alone | 0 | |
| pTVG-HP Vaccine With GM-CSF | 1 | |
| GM-CSF Alone | 0 | |
| pTVG-HP Vaccine With GM-CSF | 0 | |
| GM-CSF Alone | 0 | |
| pTVG-HP Vaccine With GM-CSF | 0 | |
| GM-CSF Alone | 49 | |
| pTVG-HP Vaccine With GM-CSF | 47 |
| Group | Value | 95% CI |
|---|---|---|
| GM-CSF Alone | 0 | |
| pTVG-HP Vaccine With GM-CSF | 1 | |
| GM-CSF Alone | 0 | |
| pTVG-HP Vaccine With GM-CSF | 0 | |
| GM-CSF Alone | 0 | |
| pTVG-HP Vaccine With GM-CSF | 0 | |
| GM-CSF Alone | 49 | |
| pTVG-HP Vaccine With GM-CSF | 47 |
| Group | Value | 95% CI |
|---|---|---|
| GM-CSF Alone | 2 | |
| pTVG-HP Vaccine With GM-CSF | 0 | |
| GM-CSF Alone | 0 | |
| pTVG-HP Vaccine With GM-CSF | 0 | |
| GM-CSF Alone | 0 | |
| pTVG-HP Vaccine With GM-CSF | 0 | |
| GM-CSF Alone | 47 | |
| pTVG-HP Vaccine With GM-CSF | 48 |
Time to metastasis was determined from the date of registration to the first CT or bone scan that demonstrated metastatic disease. As defined by RECIST 1.1 criteria.
| Group | Value | 95% CI |
|---|---|---|
| GM-CSF Alone | 18.3 | 12.3 – 24.2 |
| pTVG-HP Vaccine With GM-CSF | 18.9 | 12.0 – 24.9 |
| Group | Value | 95% CI |
|---|---|---|
| GM-CSF Alone | 9.0 | 8.8 – 12.0 |
| pTVG-HP Vaccine With GM-CSF | 8.9 | 6.0 – 11.8 |
Time frame: up to 2 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | GM-CSF Alone | pTVG-HP Vaccine With GM-CSF |
|---|---|---|---|
| Allergic reaction | Immune system disorders | — | — |
| Arthritis | Musculoskeletal and connective tissue disorders | — | — |
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | — | — |
| Cardiac disorders | Cardiac disorders | — | — |
| Chills | General disorders | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — |
| Nervous system disorders - other, specify | Nervous system disorders | — | — |
| Syncope | Nervous system disorders | — | — |
| Vasovagal reaction | Nervous system disorders | — | — |
| Reaction | System | GM-CSF Alone | pTVG-HP Vaccine With GM-CSF |
|---|---|---|---|
| Injection site reaction | General disorders | — | — |
| Fatigue | General disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Pain | General disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Hypertension | Vascular disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Flu like symptoms | General disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Chills | General disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Malaise | General disorders | — | — |
| Bone pain | Musculoskeletal and connective tissue disorders | — | — |
| Chest wall pain | Musculoskeletal and connective tissue disorders | — | — |
| Renal and urinary disorders - Other, specify | Renal and urinary disorders | — | — |
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | — | — |
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Fever | General disorders | — | — |
| Allergic reaction | Immune system disorders | — | — |
| Upper respiratory infection | Infections and infestations | — | — |
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Edema limbs | General disorders | — | — |
| Non-cardiac chest pain | General disorders | — | — |
| Rhinitis infective | Infections and infestations | — | — |
| Sinusitis | Infections and infestations | — | — |
| Bruising | Injury, poisoning and procedural complications | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Investigations - Other, specify | Investigations | — | — |
| Lymphocyte count decreased | Investigations | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — |
| Arthritis | Musculoskeletal and connective tissue disorders | — | — |
Most-reported serious reactions: Allergic reaction, Arthritis, Musculoskeletal and connective tissue disorder - Other, specify, Cardiac disorders, Chills, Myalgia, Nervous system disorders - other, specify, Syncope.
Data from ClinicalTrials.gov NCT01341652 adverse events section.
The investigators are trying to find new methods to treat prostate cancer. The approach the investigators are taking is to try to enhance patients' own immune response against the cancer. In this study the investigators will be testing the effectiveness of a vaccine that may be able to help the body fight prostate cancer.
8 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01341652.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing