Summary

for males ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

The ProVent study is a randomized, open-label study designed to assess the efficacy of sipuleucel-T in reducing the progression of lower risk non-metastatic prostate cancer compared to subjects followed on active surveillance as standard of care.

Official Title

A Randomized Phase 3, Open-Label Trial of Sipuleucel-T Administered To Patients On Active Surveillance For Newly Diagnosed Prostate Cancer

Details

The ProVent Study is designed to look at subjects who recieve sipuleucel-T compared to control subjects followed on AS as standard of care. The study will enroll subjects being followed by AS and diagnosed within 12 months prior to Screening with either ISUP Grade Group 1 or 2 adenocarcinoma of the prostate.

The Screening Phase will begin at the completion of the informed consent process and continues until randomization. After Screening assessments are completed, eligible subjects will be randomized 2:1 to the sipuleucel-T arm or the control arm. Subjects randomized to sipuleucel-T arm will receive product as described in the sipuleucel-T approved label.

Subjects randomized to the control arm will be followed on AS as standard of care. The Active Phase will begin at randomization and continues through completion of the end of Active Phase study visit (within 30 days of Biopsy 2). Once a subject from either the sipuleucel-T or control arms completes the end of Active Phase visit, they will enter the Follow-up Phase and complete Follow-up Phase visits every 6 months starting from their last Active Phase visit. The Follow-up Phase visits end when the last subject enrolled completes Biopsy 2 and end of Active Phase visit or until the study is terminated by the sponsor.

Keywords

Adenocarcinoma of the Prostate ISUP Grade Group 1 or 2 Min of 3 positive biopsy cores or 1 core with >/= 50% cancer from a systematic biopsy Prostatic Neoplasms Adenocarcinoma sipuleucel-T

Eligibility

You can join if…

Open to males ages 18 years and up

    1. Age is ≥ 18 years
    1. Written informed consent provided prior to the initiation of study procedures
    1. Histologically proven adenocarcinoma of the prostate diagnosed (ultrasound guided prostate biopsy with 10 ≥ cores) ≤12 months of Screening. All biopsy slides with subject information redacted must be submitted for BICR.
    1. Prostate cancer determined by BICR as either:
  • ISUP Grade Group 1 with 3 or more cores positive or 1 core positive with ≥50%cancer involvement from a systematic biopsy
  • ISUP Grade Group 2 (< 50% of cores positive from a systematic biopsy)
    1. Subject consents to standard of care for biopsy frequency of 2 on-study prostate biopsies and to provide biopsy tissue for study endpoint analysis.
    1. Estimated life expectancy ≥ 10 years
    1. Candidate for primary curative therapy (e.g., surgery or radiation) if prostate cancer progression occurs
    1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    1. Adequate baseline hematologic, renal, and liver function tests as evidenced by laboratory test results within the following ranges ≤30 days prior to randomization White blood cell (WBC) count ≥ 3.0 x 106 cells/mL Absolute neutrophil count (ANC) ≥1.5 x 106 cells/mL Platelet count ≥ 1.0 x105 cells/uL Hemoglobin (Hgb) ≥ 10.0 g/dL Creatinine ≤ 1.5 mg/dL Total bilirubin ≤ 1.5 x upper limit of normal (ULN) Alanine aminotransferase (ALT) ≤ 1.5 x ULN Aspartate aminotransferase (AST) ≤ 1.5 x ULN

You CAN'T join if...

    1. Former therapy for prostate cancer (local or systemic)
    1. Any previous prostatic surgical procedure that significantly changes the anatomy of prostate (at the discretion of sponsor's Medical Monitor)
    1. Any investigational product received for prostate cancer
    1. Prostate biopsy specimen reveals neuroendocrine or small cell features
    1. Primary Gleason score is ≥ 4 or any Gleason pattern 5
    1. Any evidence of locally advanced, regional or metastatic disease, including regional and distant lymph node enlargement (Nodes ≥1.5 cm in the short axis are considered pathologic and measurable)
    1. A history of a cerebrovascular event (CVE) or transient ischemic attack (TIA)
    1. Subject has used a 5-alpha-reductase inhibitor (e.g., finasteride or dutasteride)continuously for ≥ 6 months and within 6 months prior to study Screening
    1. Subject has a history of any other stage I-IV malignancy, except for basal or squamous cell skin cancer. The subject must be disease free and off any malignancy-related treatment for at least 5 years.
    1. Subject has prior use within 30 days of study Screening of any herbal, dietary, or alternative anti-cancer treatment or product, such as PC-SPES (or PC-x product), saw palmetto, ketoconazole, an estrogen-containing nutraceutical, or high dose calcitriol(>0.5 μg/day). The Investigator will consider herbal therapies on a case-by-case basis to determine whether they fall into the category of prohibited medications based on their potential for hormonal or anti-cancer or anti-cancer properties.
    1. Need for systemic chronic immunosuppressive therapy (e.g., anti-tumor necrosis factor alpha monoclonal antibodies, glucocorticoids)
    1. Any uncontrolled, concurrent illness including, but not limited to the following:ongoing or active infection (bacterial, viral, or fungal), symptomatic congestive heart failure (New York Classification III-IV) or unstable angina pectoris within the last 6 months, or psychiatric illness that would limit compliance with study requirements
    1. Hypogonadal (T <200 ng/dL) or on continuous testosterone replacement therapy
    1. Positive serology for HIV-1, HIV-2 or HTLV-1, HTLV-2
    1. Active hepatitis B or C
    1. Any medical intervention, any other condition, or any other circumstance which, in the opinion of the investigator or the sponsor's Medical Monitor, could compromise adherence with study requirements or otherwise compromise the study's objectives.

Locations

  • University of California San Diego Moores Cancer Center not yet accepting patients
    La Jolla California 92093 United States
  • University of California Irvine not yet accepting patients
    Orange California 92868 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Dendreon
ID
NCT03686683
Phase
Phase 3
Study Type
Interventional
Last Updated