RECRUITING

Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T

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Conditions

Metastatic Castration-Resistant Prostate Cancer (mCRPC)Single DoseSipuleucel-TImmune Response RateSafetyAdenocarcinoma of the Prostate

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A multicenter, open-label, prospective study to investigate immune boost response changes in patients with metastatic castrate-resistant prostate cancer (mCRPC).

Official Title

An Open -Label, Multicenter Study of Subjects With Metastatic Castrate-Resistant Prostate Cancer Treated With PROVENGE ® and Boosted With A Single Infusion of Sipuleucel-T to Measure Immune Response

Quick Facts

Study Start:2023-10-02
Study Completion:2032-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06134232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Potential subjects are men aged ≥18 years who are clinically indicated for treatment with PROVENGE® (asymptomatic or minimally symptomatic metastatic castrate-resistant \[hormone refractory\] prostate cancer).
  2. 2. Have qualified for on-label PROVENGE® infusion
  3. 3. Have received all 3 infusions of PROVENGE® prior to randomization
  4. 4. Written informed consent provided prior to the initiation of study procedures
  5. 5. Estimated life expectancy ≥12 months
  1. 1. Men who are not clinically indicated for treatment with PROVENGE® (asymptomatic or minimally symptomatic metastatic castrate-resistant \[hormone refractory\] prostate cancer).
  2. 2. Need for systemic chronic immunosuppressive therapy, including antitumor necrosis factor alpha monoclonal antibodies, glucocorticoids, systemic steroids, blood products, GM-CSF or granulocyte colony-stimulating factor (G-CSF), any vaccinations, or experimental and investigational therapies (see Section 6.3.1)
  3. 3. Uncontrolled, concurrent illness, including, but not limited to the following: ongoing or active infection (bacterial, viral, or fungal), or psychiatric illness that would limit compliance with study requirements, as well as any condition that would preclude a subject from completing PROVENGE® or sipuleucel-T treatment.
  4. 4. On experimental or investigational therapy.

Contacts and Locations

Study Contact

Margaret Warner-Lubin
CONTACT
2064588358
ProvONE@dendreon.com

Principal Investigator

Nadeem Sheikh, PhD
STUDY_DIRECTOR
Dendreon Pharmaceuticals, LLC
Benjamin Lowentritt, MD
STUDY_CHAIR
Chesapeake Urology

Study Locations (Sites)

Arizona Urology Specialists
Tuscon, Arizona, 85741
United States
City of Hope - National Medical Center
Duarte, California, 91010
United States
Urology Associates of Central California Medical Group
Fresno, California, 93720
United States
Unio Health Partners - Genesis Research, LLC
San Diego, California, 92123
United States
Colorado Urology
Lakewood, Colorado, 80228
United States
Advanced Urology Institute
Daytona Beach, Florida, 32114
United States
Advanced Urology Institute
Largo, Florida, 33771
United States
Advanced Urology Institute
Ocala, Florida, 34471
United States
Florida Urology Partners
Riverview, Florida, 33578
United States
Associated Urological Specialists
Chicago Ridge, Illinois, 60415
United States
UroPartners
Glenview, Illinois, 60026
United States
Advanced Urology Associates
New Lenox, Illinois, 60451
United States
Urology of Indiana
Carmel, Indiana, 46032
United States
First Urology
Jeffersonville, Indiana, 47130
United States
Urologic Specialists of Northwest Indiana
Merrillville, Indiana, 46410
United States
Chesapeake Urology Research Associates
Towson, Maryland, 21204
United States
Michigan Institute of Urology
Troy, Michigan, 48084
United States
Specialty Clinical Research of St. Louis
St Louis, Missouri, 63141
United States
Integrated Medical Professionals
North Hills, New York, 11040
United States
Associated Medical Professionals of NY
Syracuse, New York, 13210
United States
Associated Urologists of North Carolina
Raleigh, North Carolina, 27612
United States
The Urology Group
Cincinnati, Ohio, 45212
United States
Central Ohio Urology Group
Gahanna, Ohio, 43230
United States
Oregon Urology Institute
Springfield, Oregon, 97477
United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004
United States
Keystone Urology Specialists
Lancaster, Pennsylvania, 17604
United States
Lowcountry Urology Institute
Charleston, South Carolina, 29406
United States
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, 29572
United States
Urology Associates of Nashville
Nashville, Tennessee, 37209
United States
Urology of Virginia
Virginia Beach, Virginia, 23462
United States
Spokane Urology
Spokane, Washington, 99202
United States

Collaborators and Investigators

Sponsor: Dendreon

  • Nadeem Sheikh, PhD, STUDY_DIRECTOR, Dendreon Pharmaceuticals, LLC
  • Benjamin Lowentritt, MD, STUDY_CHAIR, Chesapeake Urology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-02
Study Completion Date2032-06-30

Study Record Updates

Study Start Date2023-10-02
Study Completion Date2032-06-30

Terms related to this study

Keywords Provided by Researchers

  • Single Dose
  • Sipuleucel-T
  • Immune Response Rate
  • Safety
  • Adenocarcinoma of the Prostate

Additional Relevant MeSH Terms

  • Metastatic Castration-Resistant Prostate Cancer (mCRPC)