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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03686683
Recruitment Status : Active, not recruiting
First Posted : September 27, 2018
Last Update Posted : October 10, 2019
Sponsor:
Collaborator:
PRA Health Sciences
Information provided by (Responsible Party):
Dendreon

Brief 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.

Condition or disease Intervention/treatment Phase
Adenocarcinoma of the Prostate Biological: sipuleucel-T Phase 3

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized 2:1 to the sipuleucel-T arm or the control arm.Subjects randomized to sipuleucel-T arm will receive 3 infusions of sipuleucel-T at approximately 2-week intervals. Subjects randomized to the control arm will be followed on AS as standard of care described in the schedule of events.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Randomized Phase 3, Open-Label Trial of Sipuleucel-T Administered To Patients On Active Surveillance For Newly Diagnosed Prostate Cancer
Actual Study Start Date : October 18, 2018
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Treatment Group: Sipuleucel-T
Sipuleucel-T is an autologous cellular immunotherapy available as a suspension for intravenous infusion. Subjects randomized to sipuleucel-T arm will receive 3 infusions of sipuleucel-T at approximately 2-week intervals.
Biological: sipuleucel-T
Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).

No Intervention: Control Arm: Active Surveillance
Subjects randomized to the control arm will be followed on Active Surveillance described in the schedule of events.



Primary Outcome Measures :
  1. To assess the efficacy of sipuleucel-T in reducing histopathologic reclassification to a higher Gleason grade in prostate cancer subjects on active surveillance (AS) [ Time Frame: Once all subjects have completed at least 3 years following randomization ]

    Proportion of subjects without histological reclassification (Gleason group upgrade) within 36 months of randomization as determined by Blinded Independent Central Review (BICR)

    o Upgrade is defined as subjects at randomization with either International Society of Urological Pathology (ISUP) Grade Group 1 (Gleason 3+3) upgraded to Grade Group 2 (Gleason 3+4) or higher or subjects at randomization with Grade Group 2 upgraded to Grade Group 3 (Gleason 4+3) or higher.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Males with proven adenocarcinoma of the prostate
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03686683


  Hide Study Locations
Locations
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United States, Arizona
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Arizona Institute of Urology
Tucson, Arizona, United States, 85741
Urological Associates of Southern Arizona - East Office
Tucson, Arizona, United States, 85741
United States, Arkansas
Arkansas Urological Associates, PA
Little Rock, Arkansas, United States, 72211
United States, California
University of California San Diego Moores Cancer Center
La Jolla, California, United States, 92093
City of Hope
Los Angeles, California, United States, 90033
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States, 90073
University of California Irvine
Orange, California, United States, 92868
John Wayne Cancer Institute
Santa Monica, California, United States, 90404
Skyline Urology
Torrance, California, United States, 90505
United States, Colorado
University of Colorado Hospital Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
The Urology Center of Colorado
Denver, Colorado, United States, 80211
Foothills Urology- Golden Office
Golden, Colorado, United States, 80401
United States, Florida
Advanced Urology Institute
Daytona Beach, Florida, United States, 32114
United States, Georgia
Advanced Urology Institute of Georgia
Roswell, Georgia, United States, 30076
United States, Illinois
Cook County Health
Chicago, Illinois, United States, 60612
Rush University
Chicago, Illinois, United States, 60612
Research by Design
Chicago, Illinois, United States, 60643
Gottlieb Memorial Hospital
Glenview, Illinois, United States, 60026
NorthShore University HealthSystem
Glenview, Illinois, United States, 60026
Advanced Urology Associates
Joliet, Illinois, United States, 60431
Comprehensive Urologic Care
Lake Barrington, Illinois, United States, 60010
United States, Indiana
First Urology
Jeffersonville, Indiana, United States, 47130
United States, Iowa
Iowa Clinical Research Corp.
West Des Moines, Iowa, United States, 50266
United States, Kansas
Kansas City Urology Care, PA
Overland Park, Kansas, United States, 66211
Wichita Urology Group Research
Wichita, Kansas, United States, 67226
United States, Louisiana
Tulane University
New Orleans, Louisiana, United States, 70112
Regional Urology, LLC
Shreveport, Louisiana, United States, 71106
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21224
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
Chesapeake Urology
Towson, Maryland, United States, 21204
United States, Michigan
A. Alfred Taubman Health Care Center
Ann Arbor, Michigan, United States, 48109
Michigan Institute of Urology, PC
Troy, Michigan, United States, 48084
United States, Mississippi
The Urology Group
Southaven, Mississippi, United States, 38671
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Adult Pediatric Urology and Urogynecology - Omaha
Omaha, Nebraska, United States, 68114
Urology Cancer Center and GU Research Network
Omaha, Nebraska, United States, 68130
United States, New Jersey
Urology Center of Englewood
Englewood, New Jersey, United States, 07631
Delaware Valley Urology
Mount Laurel, New Jersey, United States, 08054
United States, New York
Integrated Medical Professionals, PLLC
Melville, New York, United States, 11747
Mount Sinai Health System
New York, New York, United States, 10029
Associated Medical Professionals of NY, PLLC (AMP)
Syracuse, New York, United States, 13210
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Vidant Medical Center
Greenville, North Carolina, United States, 27834
Associated Urologists of North Carolina - Raleigh
Raleigh, North Carolina, United States, 27612
United States, Ohio
The Urology Group - Norwood Campus
Cincinnati, Ohio, United States, 45212
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Aventiv Research - Colombus
Gahanna, Ohio, United States, 43230
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Oregon Urology Institute Research
Springfield, Oregon, United States, 97477
United States, Pennsylvania
Urologic Consultants of Southeastern Pennsylvania
Bala-Cynwyd, Pennsylvania, United States, 19004
Lancaster Urology
Lancaster, Pennsylvania, United States, 17604
United States, Rhode Island
Omega Medical Research
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
The Conrad Pearson Clinic
Germantown, Tennessee, United States, 38138
Urology Associates
Nashville, Tennessee, United States, 37209
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Texas
Mary Crowley Cancer Research
Dallas, Texas, United States, 75230
Urology San Antonio
San Antonio, Texas, United States, 78229
United States, Virginia
Virginia Urology
Richmond, Virginia, United States, 23235
Urology of Virginia
Virginia Beach, Virginia, United States, 23462
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Dendreon
PRA Health Sciences
Investigators
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Study Director: Bruce Brown, MD Dendreon Pharmaceuticals LLC

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Responsible Party: Dendreon
ClinicalTrials.gov Identifier: NCT03686683     History of Changes
Other Study ID Numbers: P17-1
ProVent ( Other Identifier: Dendreon Pharmaceuticals LLC )
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dendreon:
ISUP Grade Group 1 or 2
Number biopsies 1 or >1 (≤12 months of Screening)
Additional relevant MeSH terms:
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Adenocarcinoma
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type