Trial record 2 of 2 for:    ProVent | Prostate Cancer

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03686683
Recruitment Status : Recruiting
First Posted : September 27, 2018
Last Update Posted : January 10, 2019
PRA Health Sciences
Information provided by (Responsible Party):

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 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.

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 as standard of care 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

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 diagnosed (ultrasound guided prostate biopsy with 10 ≥ cores) ≤12 months of Screening. All biopsy slides with subject information redacted must be submitted for BICR.
  • 4. Prostate cancer determined by BICR as either:

    1. ISUP Grade Group 1 with 3 or more cores positive or 1 core positive with ≥50% cancer involvement from a systematic biopsy
    2. ISUP Grade Group 2 (< 50% of cores positive from a systematic biopsy)
  • 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) ≤ 1.5 x ULN Aspartate aminotransferase (AST) ≤ 1.5 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. 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
  • 13. Hypogonadal (T <200 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 identifier (NCT number): NCT03686683

Contact: Evett Espiritu 206.829.1516
Contact: PRA (CRO) 1-800-772-3125 ext 170101

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Sponsors and Collaborators
PRA Health Sciences
Study Director: Bruce Brown, MD Dendreon Pharmaceuticals LLC

Responsible Party: Dendreon 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: January 10, 2019
Last Verified: January 2019

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
Min of 3 positive biopsy cores or 1 core with >/= 50% cancer from a systematic biopsy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Genital Diseases, Male