West Cancer Center

PROSTATE: Metastatic; CRPC; 1st line; "Prospect"

A randomized, double-bline, phase 3 efficacy trial of PROSTVAC-V/F +/- GM-CSF in men with asym,ptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer

Title

Bavarian Nordic BNIT-PRV-301

Study Title

A randomized, double-bline, phase 3 efficacy trial of PROSTVAC-V/F +/- GM-CSF in men with asym,ptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer

Site Link

NCT01322490

Malignancy

Prostate, Castration Resistant Prostate, CRPC

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

1st line (chemo-naive)

Investigational Agent

PROSTVAC-VF

Drug Class

anti-PSA vaccine

Brad Somer, MD

Sponsor

Bavarian Nordic

Phase

Phase 3

Status

Closed to Accrual

Key Eligibility Criteria

Key Eligibility Criteria Details

Asymptomatic or minimally symptomatic mCRPC
Documented PD post castration or ADT (PSA progression allowed)
Prior vaccination against smallpox (vaccinia)
No opiates to control cancer pain
No mets to sites other than LNs or bone
PSA doubling time must be >1 month
No atopic dermatitis_ or active autoimmune disease
No severe cardiac abnormalities

Objective

Primary- OS: Secondary- 6month event-free survival

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Adenocarcinoma

Dosing Frequency

PROSTVAC-V/F +/- GM-CSF

Control Agents

placebo PROSTVAC, placebo GM-CSF

Study Protocol

Randomized

Yes