Prostvac in Patients With Biochemically Recurrent Prostate Cancer

NCT02649439 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 16003516-C-0035
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 3

Brief Summary

Background: Some people who have been treated for prostate cancer still have high prostate-specific antigen (PSA) levels. This may indicate cancer. These people have non-metastatic castration sensitive prostate cancer (nmCSPC) or biochemical recurrent prostate cancer. Researchers think the immune system can be taught to fight and kill cancer cells. They think an immunotherapy vaccine called prostvac could help reduce PSA levels in people with this type of prostate cancer. Objective: To test if prostvac can decrease tumor growth rate as measured by PSA compared to getting surveillance alone. Eligibility: Men ages 18 or older who have nmCSPC or biochemical recurrent prostate cancer Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Bone scan Computed tomography (CT) scan, or magnetic resonance imaging (MRI) and positron emission tomography (PET) scan: They lie in a machine that takes pictures of the body. Electrocardiogram: Soft electrodes are stuck to the skin to record heart signals. Participants will be part of 1 of 2 arms: Arm A will get prostvac for 6 months. Arm B will have surveillance for 6 months followed by prostvac for 6 months. During the prostvac period, participants will get prostvac as a shot under the skin on weeks 1, 3, and 5, and then monthly for a total of 5 months. Participants will have follow-up visits at least every month until they recover from prostvac side effects or their cancer worsens. Visits may include repeats of screening tests. Participants will be followed for up to 15 years. They will have a physical exam every year for the first 5 years. They will have phone calls once a year.

Conditions

Prostate Cancer

Keywords

Vaccine; PSA; Surveillance; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Tumor Growth Rate as Measured by Prostate-specific Antigen (PSA) Rise After 6 Months When PROSTVAC is Initiated Compared to a Group on Surveillance for 6 Months

  Tumor growth rate was measured using the equation PSA (log growth rate) +/- SE (standard error).

  6 months

Secondary Outcomes (2)

• Effects of Vaccine on Prostate-specific Antigen (PSA) Growth Rate When PROSTVAC is Initiated After 6 Months on Surveillance

  After the participants in the Arm/Group "B/ Delayed PROSTVAC Treatment" received treatment for 6 months after their 6 month surveillance (e.g., 12 months total).

• Number of Participants With Prostate-specific Antigen (PSA) Specific T-Cells at Baseline and 6 Months

  Baseline and 6 months

Other Outcomes (4)

• Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)

  Date treatment consent signed to date off study, approximately 55 months and 13 days for Arm/Group A, and 57 months and 22 days for Arm/Group B.

• Median Late Change in Peripheral Blood Mononuclear Cells (PBMCs) in Refined Subsets Monocyte Nonclassical, Monocyte Nonclassical Programmed Death Ligand 1 (PD-L1+), and Monocyte PD-1+ After PROSTVAC

  Day 29 (Post vaccination) vs Pre (Baseline)

• Median Late Change in Peripheral Blood Mononuclear Cells (PBMCs) in Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8), Regulatory T-cells (Treg), Natural Killer (NK), and Myeloid-derived Suppressor Cells (MDSC) After PROSTVAC

  Day 29 (Post vaccination) vs Pre (Baseline)

Study Arms (2)

A/PROSTVAC treatment

EXPERIMENTAL

PROSTVAC treatment for 6 months with an additional optional year of maintenance for eligible patients

Biological: PROSTVAC -V; Biological: PROSTVAC-F

B/ Delayed PROSTVAC treatment

EXPERIMENTAL

Surveillance for 6 months followed by PROSTVAC treatment for 6 months with an additional year of maintenance for eligible patients

Biological: PROSTVAC -V; Biological: PROSTVAC-F

Interventions

PROSTVAC -V BIOLOGICAL

Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus

A/PROSTVAC treatment; B/ Delayed PROSTVAC treatment

PROSTVAC-F BIOLOGICAL

Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus

A/PROSTVAC treatment; B/ Delayed PROSTVAC treatment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histopathological documentation of prostate cancer confirmed in either the Laboratory of Pathology at the National Institutes of Health (NIH) Clinical Center, Walter Reed National Military Medical Center, Memorial Sloan Kettering Cancer Center (MSKCC), Dana-Farber Cancer Institute (DFCI) or Beth Israel Deaconess Medical Center (BIDMC) 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.
• Biochemical progression after definitive radiation or surgery defined as follows:
• For patients following definitive therapy: a rise in prostate-specific antigen (PSA) of greater than or equal to 2ng/mL above the nadir (per Radiation Therapy Oncology Group (RTOG)-American Society for Therapeutic Radiology and Oncology (ASTRO) consensus criteria).
• For patients following radical prostatectomy: rising PSA after surgical procedure. (Patients must have a PSA greater than or equal to 0.8 ng/ml)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 1 (Karnofsky greater than or equal to 80%).
• Patients must have a PSA doubling time of 5-15 months.
• Patients must have a rising PSA as confirmed by 3 values done at least 1 week apart and over no less than 1 month.
• Recovery from acute toxicity related to prior therapy, including surgery and radiation, or no toxicity greater than or equal to grade 2.
• Negative computed tomography (CT) scan/magnetic resonance imaging (MRI) and bone scan for metastatic prostate cancer.
• 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 10g/dL
• Biochemical eligibility parameters (within 16 days before starting therapy):
• Hepatic function: bilirubin less than or equal to 1.5mg/dL (OR in patients with Gilbert's syndrome normal.

You may not qualify if:

• Immunocompromised status due to:
• Human immunodeficiency virus (HIV) positivity.
• Active autoimmune diseases such as Addison's disease, Hashimoto's thyroiditis, systemic lupus erythematosus, Sjogren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome or active Grave's disease. Patients with a history of autoimmunity that has not required systemic immunosuppressive therapy or does not threaten vital organ function including central nervous system (CNS), heart, lungs, kidneys, skin, and gastrointestinal (GI) tract will be allowed.
• Other immunodeficiency diseases
• Splenectomy
• Chronic administration (defined as daily or every other day for continued use \> 14 days) of corticosteroids deemed systemic by investigator within 28 days before the first planned dose of PROSTVAC. Use of inhaled steroids, nasal sprays, intra-articular injections and topical creams for small body areas is allowed.
• Serious intercurrent medical illness that, in the judgment of the investigator, would interfere with patient s ability to carry out the treatment program.
• 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)
• History of prior chemotherapy
• History of prior immunotherapy within the last 3 years
• Major surgery within 4 weeks prior to enrollment (Day 1 visit).
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to poxviral vaccines (e.g., vaccinia vaccine)
• Known allergy to eggs, egg products, aminoglycoside antibiotics (for example, gentamicin or tobramycin).
• History of atopic dermatitis or active skin condition (acute, chronic, exfoliative) that disrupts the epidermis
• Previous serious adverse reactions to smallpox vaccination

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (3)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

PROSTVAC

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Ravi Madan
• Organization: National Cancer Institute

rm480i@nih.gov

301-480-7168

Study Officials

• Ravi A Madan, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 6, 2016
• First Posted: January 7, 2016
• Study Start: December 22, 2015
• Primary Completion: March 28, 2019
• Study Completion: October 1, 2022
• Last Updated: November 14, 2022
• Results First Posted: July 6, 2021

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)