Prostate Cancer Clinical Trial

Open- Label Trial of Sipuleucel-T Administered to Active Surveillance Patients for Newly Diagnosed Prostate Cancer

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.

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Full Description

The ProVent Study is designed to look at subjects who recieve sipuleucel-T compared to control subjects followed on AS. The study will enroll subjects being followed by AS and initially 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 will undergotheir first leukapheresis within 60 days of randomization.

Subjects randomized to the control arm will be followed on AS. 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

1. Age is ≥ 18 years
2. Written informed consent provided prior to the initiation of study procedures
3. Histologically proven adenocarcinoma of the prostate initially diagnosed ≤12 months of Screening. All biopsy slides with subject information redacted must be submitted for BICR.
4. Prostate cancer diagnosis determined by BICR as one of the following: 4a. ISUP Grade Group 1 with 3 or more cores positive from a systematic (≥10 cores) biopsy 4b. ISUP Grade Group 1 with ≥ 1 core positive with ≥50% cancer involvement from a systematic (≥10 cores) biopsy 4c. ISUP Grade Group 1 from 3 or more positive cores from any combination of cores from a systematic (≥10 cores) biopsy and MRI targeted biopsy (note: multiple cores from each MRI targeted lesion will count as 1 core) 4d. ISUP Grade Group 1 from a negative systematic (≥10 cores) biopsy and an MRI targeted core positive with ≥50% cancer involvement 4e. ISUP Grade Group 2 from a systematic (≥10 cores) biopsy with <50% of the total number of any cores positive for cancer 4f. ISUP Grade Group 2 from a negative systematic (≥10 cores) biopsy and MRI targeted core(s) positive for Gleason 3+4 (see note below) 4g. ISUP Grade Group 2 from any combination of cores from a systematic (≥10 cores) biopsy and MRI targeted biopsy (see note below)

Note for 4f and 4g: the total number of positive cores must be <50% of total cores from both the systematic biopsy and MRI targeted lesions; each MRI targeted lesion, irrespective of multiple positive cores, will each count as 1 core for the total number of positive cores, e.g., 4 targeted lesions with 2 positive cores each will only add 4 to the total core count.

5. Subject consents to standard of care for biopsy frequency of 2 on-study prostate biopsies and to provide biopsy tissue for study endpoint analysis.
6. Estimated life expectancy ≥ 10 years
7. Candidate for primary curative therapy (e.g., surgery or radiation) if prostate cancer progression occurs
8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
9. 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 10^6 cells/mL Absolute neutrophil count (ANC) ≥ 1.5 x 10^6 cells/mL Platelet count ≥ 1.0 x10^5 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) ≤ 2.0 x ULN Aspartate aminotransferase (AST) ≤ 2.0 x ULN

Exclusion Criteria:

1. Former therapy for prostate cancer (local or systemic)
2. Any previous prostatic surgical procedure that significantly changes the anatomy of prostate (at the discretion of sponsor's Medical Monitor)
3. Any investigational product received for prostate cancer
4. Prostate biopsy specimen reveals neuroendocrine or small cell features
5. Primary Gleason score is ≥ 4 or any Gleason pattern 5
6. 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)
7. A history of a cerebrovascular event (CVE) or transient ischemic attack (TIA)
8. 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
9. 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.
10. 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.
11. Need for systemic chronic immunosuppressive therapy (e.g., anti-tumor necrosis factor alpha monoclonal antibodies, glucocorticoids)
12. 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 as well as any condition that would preclude a subject from undergoing leukapheresis (e.g., within the previous 6 months: myocardial infarction, interventional cardiology procedure such as angioplasty or stent placement, pulmonary embolism or deep vein thrombosis).
13. Hypogonadal (T <175 ng/dL) or on continuous testosterone replacement therapy
14. Positive serology for HIV-1, HIV-2 or HTLV-1, HTLV-2
15. Active hepatitis B or C
16. 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.

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

450

Study ID:

NCT03686683

Recruitment Status:

Active, not recruiting

Sponsor:

Dendreon

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There are 53 Locations for this study

See Locations Near You

Banner MD Anderson Cancer Center
Gilbert Arizona, 85234, United States
Arizona Institute of Urology
Tucson Arizona, 85741, United States
Urological Associates of Southern Arizona - East Office
Tucson Arizona, 85741, United States
Arkansas Urological Associates, PA
Little Rock Arkansas, 72211, United States
University of California San Diego Moores Cancer Center
La Jolla California, 92093, United States
VA Greater Los Angeles Healthcare System
Los Angeles California, 90073, United States
University of California Irvine
Orange California, 92868, United States
John Wayne Cancer Institute
Santa Monica California, 90404, United States
Skyline Urology
Torrance California, 90505, United States
University of Colorado Hospital Anschutz Cancer Pavilion
Aurora Colorado, 80045, United States
The Urology Center of Colorado
Denver Colorado, 80211, United States
Foothills Urology- Golden Office
Golden Colorado, 80401, United States
Advanced Urology Institute
Daytona Beach Florida, 32114, United States
Advanced Urology Institute of Georgia
Roswell Georgia, 30076, United States
Cook County Health
Chicago Illinois, 60612, United States
Rush University
Chicago Illinois, 60612, United States
Research by Design
Chicago Illinois, 60643, United States
Gottlieb Memorial Hospital
Glenview Illinois, 60026, United States
NorthShore University HealthSystem
Glenview Illinois, 60026, United States
Advanced Urology Associates
Joliet Illinois, 60431, United States
Comprehensive Urologic Care
Lake Barrington Illinois, 60010, United States
First Urology
Jeffersonville Indiana, 47130, United States
Iowa Clinical Research Corp.
West Des Moines Iowa, 50266, United States
Kansas City Urology Care, PA
Overland Park Kansas, 66211, United States
Wichita Urology Group Research
Wichita Kansas, 67226, United States
Tulane University
New Orleans Louisiana, 70112, United States
Regional Urology, LLC
Shreveport Louisiana, 71106, United States
Johns Hopkins University School of Medicine
Baltimore Maryland, 21224, United States
Walter Reed National Military Medical Center
Bethesda Maryland, 20889, United States
Chesapeake Urology
Towson Maryland, 21204, United States
A. Alfred Taubman Health Care Center
Ann Arbor Michigan, 48109, United States
Michigan Institute of Urology, PC
Troy Michigan, 48084, United States
The Urology Group
Southaven Mississippi, 38671, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Adult Pediatric Urology and Urogynecology - Omaha
Omaha Nebraska, 68114, United States
Urology Cancer Center and GU Research Network
Omaha Nebraska, 68130, United States
Delaware Valley Urology
Mount Laurel New Jersey, 08054, United States
Integrated Medical Professionals, PLLC
Melville New York, 11747, United States
Mount Sinai Health System
New York New York, 10029, United States
Associated Medical Professionals of NY, PLLC (AMP)
Syracuse New York, 13210, United States
Associated Urologists of North Carolina - Raleigh
Raleigh North Carolina, 27612, United States
The Urology Group - Norwood Campus
Cincinnati Ohio, 45212, United States
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States
Oregon Urology Institute Research
Springfield Oregon, 97477, United States
Urologic Consultants of Southeastern Pennsylvania
Bala-Cynwyd Pennsylvania, 19004, United States
Lancaster Urology
Lancaster Pennsylvania, 17604, United States
Omega Medical Research
Warwick Rhode Island, 02886, United States
Carolina Urologic Research Center
Myrtle Beach South Carolina, 29572, United States
The Conrad Pearson Clinic
Germantown Tennessee, 38138, United States
Urology Associates
Nashville Tennessee, 37209, United States
Vanderbilt University
Nashville Tennessee, 37232, United States
Mary Crowley Cancer Research
Dallas Texas, 75230, United States
Urology San Antonio
San Antonio Texas, 78229, United States
Virginia Urology
Richmond Virginia, 23235, United States
Urology of Virginia
Virginia Beach Virginia, 23462, United States
Virginia Mason Medical Center
Seattle Washington, 98101, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

450

Study ID:

NCT03686683

Recruitment Status:

Active, not recruiting

Sponsor:


Dendreon

How clear is this clinincal trial information?

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