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



Status:Recruiting
Conditions:Prostate Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:October 18, 2018
End Date:May 2023
Contact:Evett Espiritu
Email:eespiritu@Dendreon.com
Phone:206.829.1516

Use our guide to learn which trials are right for you!

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

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.

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.

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:

1. ISUP Grade Group 1 with 3 or more cores positive from a systematic (≥10 cores)
biopsy

2. ISUP Grade Group 1 with ≥ 1 core positive with ≥50% cancer involvement from a
systematic (≥10 cores) biopsy

3. 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)

4. ISUP Grade Group 1 from a negative systematic (≥10 cores) biopsy and an MRI
targeted core positive with ≥50% cancer involvement

5. ISUP Grade Group 2 from a systematic (≥10 cores) biopsy with <50% of the total
number of any cores positive for cancer

6. ISUP Grade Group 2 from a negative systematic (≥10 cores) biopsy and MRI targeted
core(s) positive for Gleason 3+4 (see note below)

7. ISUP Grade Group 2 from any combination of cores from a systematic (≥10 cores)
biopsy and MRI targeted biopsy (see note below)

Note for f and g: 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.
We found this trial at
62
sites
?
mi
from
Omaha, NE
Click here to add this to my saved trials
2200 Santa Monica Blvd
Santa Monica, California 90404
(310) 582-7438
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
400 Bald Hill Road
Warwick, Rhode Island 02886
401-739-9350
?
mi
from
Warwick, RI
Click here to add this to my saved trials
Ann Arbor, Michigan 48109
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Bala-Cynwyd, Pennsylvania 19004
?
mi
from
Bala-Cynwyd, PA
Click here to add this to my saved trials
733 North Broadway
Baltimore, Maryland 21205
(410) 955-3182
Johns Hopkins University School of Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
?
mi
from
Bloomfield, NJ
Click here to add this to my saved trials
Chicago, Illinois 60612
?
mi
from
Chicago, IL
Click here to add this to my saved trials
9730 South Western Avenue
Chicago, Illinois 60643
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Cincinnati, Ohio 45212
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Colorado Springs, Colorado 80907
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
7777 Forest Lane
Dallas, Texas 75230
?
mi
from
Dallas, TX
Click here to add this to my saved trials
545 Health Boulevard
Daytona Beach, Florida 32114
?
mi
from
Daytona Beach, FL
Click here to add this to my saved trials
Denver, Colorado 80211
?
mi
from
Denver, CO
Click here to add this to my saved trials
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
?
mi
from
Durham, NC
Click here to add this to my saved trials
Englewood, New Jersey 07631
?
mi
from
Englewood, NJ
Click here to add this to my saved trials
Gahanna, Ohio 43230
?
mi
from
Gahanna, OH
Click here to add this to my saved trials
1325 Wolf Park Drive
Germantown, Tennessee 38138
?
mi
from
Germantown, TN
Click here to add this to my saved trials
Germantown, Tennessee 38138
?
mi
from
Germantown, TN
Click here to add this to my saved trials
Gilbert, Arizona 85234
?
mi
from
Gilbert, AZ
Click here to add this to my saved trials
Glenview, Illinois 60026
?
mi
from
Glenview, IL
Click here to add this to my saved trials
Glenview, Illinois 60026
?
mi
from
Glenview, IL
Click here to add this to my saved trials
Golden, Colorado 80401
Phone: 303-985-2550
?
mi
from
Golden, CO
Click here to add this to my saved trials
Jeffersonville, Indiana 47130
?
mi
from
Jeffersonville, IN
Click here to add this to my saved trials
Joliet, Illinois 60431
?
mi
from
Joliet, IL
Click here to add this to my saved trials
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
Lake Barrington, Illinois
?
mi
from
Lake Barrington, IL
Click here to add this to my saved trials
Lancaster, Pennsylvania 17604
?
mi
from
Lancaster, PA
Click here to add this to my saved trials
Little Rock, Arkansas 72211
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Los Angeles, California 91010
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90073
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Melville, New York 11747
?
mi
from
Melville, NY
Click here to add this to my saved trials
Mount Laurel, New Jersey 08054
?
mi
from
Mount Laurel, NJ
Click here to add this to my saved trials
823 82nd Parkway, Suite B
Myrtle Beach, South Carolina 29572
(843) 449-1010 ext.268
Carolina Urologic Research Center Carolina Urologic Research Center (CURC) has been recognized both nationally and...
?
mi
from
Myrtle Beach, SC
Click here to add this to my saved trials
Nashville, Tennessee 37209
?
mi
from
Nashville, TN
Click here to add this to my saved trials
2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New Orleans, Louisiana 70112
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
New York, New York 10029
?
mi
from
New York, NY
Click here to add this to my saved trials
940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Orange, California 92868
?
mi
from
Orange, CA
Click here to add this to my saved trials
Overland Park, Kansas 66211
?
mi
from
Overland Park, KS
Click here to add this to my saved trials
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Richmond, Virginia 23235
?
mi
from
Richmond, VA
Click here to add this to my saved trials
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Antonio, Texas 78229
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Seattle, Washington 98101
(888) 862-2737
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Shreveport, Louisiana 71106
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
Springfield, Oregon 97477
?
mi
from
Springfield, OR
Click here to add this to my saved trials
?
mi
from
Syracuse, NY
Click here to add this to my saved trials
9040 Jackson Ave
Tacoma, Washington 98431
(253) 968-1110
Madigan Army Medical Center Located on Joint Base Lewis-McChord, Madigan Army Medical Center comprises a...
?
mi
from
Tacoma, WA
Click here to add this to my saved trials
Torrance, California 90505
?
mi
from
Torrance, CA
Click here to add this to my saved trials
Towson, Maryland 21204
?
mi
from
Towson, MD
Click here to add this to my saved trials
?
mi
from
Troy, MI
Click here to add this to my saved trials
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Tucson, Arizona 85715
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Virginia Beach, Virginia 23462
?
mi
from
Virginia Beach, VA
Click here to add this to my saved trials
West Des Moines, Iowa 50266
?
mi
from
West Des Moines, IA
Click here to add this to my saved trials
Wichita, Kansas 67226
?
mi
from
Wichita, KS
Click here to add this to my saved trials