Phase 2 N=74 Randomized Treatment

Docetaxel and PROSTVAC for Metastatic Castration-Sensitive Prostate Cancer

Prostate Cancer · Prostate Neoplasms · Neoplasms, Prostatic

Bottom Line

View on ClinicalTrials.gov: NCT02649855 ↗

Enrolled (actual)

Serious AEs

6.8%

Results posted

Jul 2023

Primary outcome: Primary: Antigen Spreading (i.e., a Broader Immune Response) With Greater Associated Response Score Compared to Docetaxel Alone After 19 Weeks — 4.31; 5.63; 4.00 Score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: PROSTVAC-V (Biological); PROSTVAC-F (Biological); Docetaxel (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: National Cancer Institute (NCI)
Primary completion: Jul 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Antigen Spreading (i.e., a Broader Immune Response) With Greater Associated Response Score Compared to Docetaxel Alone After 19 Weeks	4.31; 5.63; 4.00	—
SECONDARY Antigen Specific T-cell Immune Composite Response Scores Between All Arms at 39 Weeks and 1 Year	7.03; 7.29; 6.91; 5.25; 6.44	—
SECONDARY Number of Participants With T-cell Response to Prostate-specific Antigen (PSA)	7; 6; 8; 5; 13	—

Summary

Background: Metastatic castrate-sensitive prostate cancer is cancer that has spread beyond the prostate area. It can be controlled by lowering the amount of testosterone in the body. This is called androgen deprivation therapy (ADT). The vaccine PROSTVAC might help the immune system kill cancer cells. Researchers want to add PROSTVAC and docetaxel chemotherapy to ADT. They think this may work better against prostate cancer than ADT alone. Objective: To test if adding PROSTVAC and docetaxel to ADT works better against prostate cancer than ADT alone. Eligibility: Men ages 18 years and over with metastatic castrate-sensitive prostate cancer Design: Participants will be screened with: Physical exam Medical history Blood tests Possible computed tomography (CT), magnetic resonance imaging (MRI), or bone scan: Participants lie in a machine. The machine takes pictures of the body. Electrocardiogram: Soft electrodes are stuck to the skin to record heart signals. Participants will have 2 optional tumor biopsies during the study. Participants will join 1 of 2 groups. Both groups will get: ADT Docetaxel by vein Steroids by mouth or vein before each docetaxel infusion PROSTVAC injection Both groups first have ADT. One to 4 months after, they have: Group A: Docetaxel every 3 weeks for 6 cycles PROSTVAC 3 weeks after the last infusion Booster injections 2 weeks later and then every 3 weeks, for 6 boosters total Group B: PROSTVAC Booster 2 weeks later Docetaxel hours later Docetaxel and the booster every 3 weeks for 6 cycles Participants will have a visit 4-5 weeks after the last treatment. They will then have visits every 12 weeks. Participants will be followed for up to 15 years. This includes physical exams every year for 5 years.

Eligibility Criteria

INCLUSION CRITERIA:
Documented histopathological confirmation of prostate cancer-from a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory.
Patients must have metastatic disease, defined as at least one lesion on bone scan or at least one lesion that are measurable per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. (Patients who have metastatic disease by these criteria prior to ADT, but then have changes after androgen deprivation therapy (ADT) that diminish the size of these lesions or changes on bone scan are still eligible.)
Patients must have a performance status of 0 to 2 according to the Eastern Cooperative Oncology Group (ECOG) criteria
Patients must have adequate bone marrow, hepatic, and renal function with:
Absolute neutrophil count (ANC) greater than or equal to 1500/microL, without cerebrospinal fluid (CSF) support
Platelets greater than or equal to 100,000/microL
Aspartate aminotransferase (AST)/Serum glutamic-oxaloacetic transaminase (SGOT) less than or equal to 2.5 times upper limit of normal (ULN);
Alanine aminotransferase (ALT)/Serum glutamic-pyruvic transaminase (SGPT) less than or equal to 2.5 times upper limit of normal (ULN);
Total serum bilirubin less than or equal to 1.5 times upper limit of normal (ULN), OR in patients with Gilbert's syndrome, a total bilirubin less than or equal to 3.0)
Serum albumin greater than or equal to 2.8 g/dL
Lipase 14 days) of corticosteroids deemed systemic by investigator within 28 days before the first planned dose of PROSTVAC. Use of inhaled steroids, nasal sprays, and topical creams for small body areas is allowed.
Evidence of rising prostate-specific antigen (PSA) on ADT
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 (e.g. phytoestrogens and saw palmetto)
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
Unable to avoid close contact or household contact with the following high-risk individuals for three weeks after the Day 1 vaccination: (a) children less than or equal to 3 years of age, (b) pregnant or nursing women, (c) individuals with prior or concurrent extensive eczema or other eczemoid skin disorders, or (d) immunocompromised individuals, such as those with human immunodeficiency virus (HIV).
Receipt of an investigational agent within 28 days (or 60 days for an antibody-based therapy) before the first planned dose of study drugs.
Patients who test positive for hepatitis B virus (HBV) or hepatitis C virus (HCV)
Uncontrolled hypertension (systolic blood pressure (SBP)>170/ diastolic blood pressure (DBP)>105)
Patients who have had prior chemotherapy for prostate cancer.
The subject has had evidence within 2 years of the start of study treatment of another malignancy which required systemic treatment (with the exception of nonmelanoma skin cancers or carcinoma in situ of the bladder).
The subject has active brain metastases or epidural disease.
Patients with greater than or equal to grade 2 peripheral neuropathy at baseline.
Patients with history of splenectomy

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Data sourced from ClinicalTrials.gov (NCT02649855). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.