PROvenge Treatment and Early Cancer Treatment

NCT00779402 | Completed Phase 3 Results FDA Drug

• 1 other identifier: P-11
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 18

Brief Summary

The PROTECT-PROvenge Treatment and Early Cancer Treatment trial was a Phase III trial for patients with hormone sensitive prostate cancer. The study was conducted at over 15 participating centers throughout the US. The purpose of the study was to determine if sipuleucel-T was effective for treatment of early stage, non-metastatic prostate cancer. The study compared the active vaccine to control to determine whether the product delayed the time until cancer progression.

Conditions

Prostate Cancer

Keywords

cancer; prostate cancer; prostatectomy; PSA; sipuleucel-T; PROVENGE; APC8015; non-metastatic; nonmetastatic; androgen-sensitive; androgen sensitive; biochemical recurrence; biochemically recurrent; immune therapy; immunotherapy; vaccine; dendritic cells; antigen-presenting cells; antigen presenting cells; cancer vaccine; therapeutic vaccine; therapeutic cancer vaccine; biologic; booster

Outcome Measures

Primary Outcomes (2)

• Time to Biochemical Failure Cumulative Incidence Percentile

  Time to Biochemical Failure (TTBF) was the pre-specified primary endpoint of this trial. The biochemical failure threshold was based on evidence that prostate specific antigen (PSA) had become ≥ 3 ng/mL

  Every 3 months post-infusion

• Number of Subjects That Met Biochemical Failure Status

  time to biochemical Failure (TTBF) was the pre-scpecified primary endpoint of this trial. The biochemical failure threshold was based on evidence that prostate specific antigen (PSA) had become ≥ 3 ng/mL.

  Every 3 months post-infusion

Study Arms (2)

Sipuleucel-T

EXPERIMENTAL

Subjects received infusion of Sipuleucel-T, at 2-week intervals, for a total of 3 infusions.

Biological: Sipuleucel-T

Control

PLACEBO COMPARATOR

Subjects received infusion of control (autologous cellular product consisting of antigen presenting cells (APCs) prepared in the absence of PA2024 antigen) at 2-week intervals, for a total of 3 infusions.

Other: Control

Interventions

Control OTHER

Autologous cellular product consisting of antigen presenting cells (APCs) prepared in the absence of PA2024 antigen.

Control

Sipuleucel-T BIOLOGICAL

Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).

Also known as: Provenge®, APC8015

Sipuleucel-T

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic diagnosis of adenocarcinoma of the prostate.
• Within at least 3 months, but not more than 10 years, prior to initiation of the run-in phase with LHRH-a depot, the subject has undergone a radical prostatectomy for Stage T1b - T3c, N0 - N1, Nx, or M0 disease Subjects who experienced their first PSA recurrence within 2 years post completion of initial therapy of curative intent was eligible without consideration of the Gleason score of the tumor specimen. Subjects who experienced their first PSA relapse between 2 and 10 years post completion of initial therapy of curative intent was eligible only if the Gleason score of the tumor specimen was ≥ 7.
• Therapeutic PSA response to primary therapy was below 0.4 ng/mL.
• Tumor specimen positive for PAP.
• PSA relapse while not currently receiving androgen ablation therapy.
• If androgen ablation was given for a previous PSA relapse, PSA must have increased to a level at least 25% above the nadir observed while on this therapy, and to an absolute level of at least 3 ng/mL.
• Subjects who had been treated with adjuvant or salvage radiation following radical prostatectomy, or with either LHRH-a (e.g., leuprolide acetate or goserelin acetate) or non-steroidal anti-androgen therapy (e.g., bicalutamide 150 mg/day) for a prior PSA relapse, may enter the study provided: Post-prostatectomy PSA was never ≥ 20 ng/mL; PSA was not rising while subject received hormonal therapy, and; For any hormonal therapy received, the last effective day of androgen deprivation was at least 6 months prior to the date of LHRH-a depot placement.
• Confirmed Stage M0 disease.
• Estimated life expectancy of at least 1 year.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Ability to understand the trial procedures and requirements.
• ≥ 18 and ≤ 80 years of age.
• Ability to understand and willingness to sign an informed consent form.

You may not qualify if:

• Metastasis.
• Clinical evidence of local recurrence other than PSA elevation (e.g., palpable induration or mass in the prostatic fossa).
• Any surgery within 4 weeks prior to the date of LHRH-a depot placement.
• Prior orchiectomy.
• PSA ≥ 20 ng/mL at any time after radical prostatectomy.
• Current systemic steroid therapy (inhaled or topical steroids are acceptable).
• Any chemotherapy within 4 months prior to the LHRH-a depot placement.
• Prior immunotherapy or therapy with other experimental agents for prostate cancer.
• Treatment with radioactive seeds within 12 months prior to the LHRH a depot placement.
• History of any other prior malignancy other than resected basal or squamous cell carcinoma of the skin within 5 years of entry.
• Concurrent participation in another clinical trial involving experimental medication.
• Any disease, condition, social, or geographical constraint that in the opinion of the Investigator or medical monitor reduced the probability that the subject will complete the trial or affects the evaluation of study end points
• Central laboratory value of PSA ≥ 1 ng/mL at the end of the LHRH-a run-in phase.
• Randomized more than 3 weeks following the last effective date of testicular androgen suppression (as described in the package insert).
• Any use of herbal preparations (e.g., Prostate Cancer (PC) -SPES or saw palmetto) within 4 weeks prior to randomization.

Sponsors & Collaborators

• Dendreon: lead

Study Sites (18)

Alta Bates Comprehensive Cancer Center

Berkeley, California, 94704, United States

Location

South Orange County Medical Research

Laguna Hills, California, 92653, United States

Location

University of Colorado Health Sciences Center

Aurora, Colorado, 80045-3206, United States

Location

Oncology Specialists, SC

Park Ridge, Illinois, 60068-1174, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642-0001, United States

Location

McKay Urology

Charlotte, North Carolina, 28207, United States

Location

AKSM Clinical Research Group

Columbus, Ohio, 43214, United States

Location

Providence Medical Center

Portland, Oregon, 97213, United States

Location

Oregon Health and Sciences University

Portland, Oregon, 97239, United States

Location

Oregon Urology Institute

Springfield, Oregon, 97477, United States

Location

Urology Health Specialists - Bryn Mawr

Bryn Mawr, Pennsylvania, 19010, United States

Location

Albert Einstein Medical Building

Philadelphia, Pennsylvania, 19141, United States

Location

Bryn Mawr Urology Group

Rosemont, Pennsylvania, 19010, United States

Location

University of Tennessee

Memphis, Tennessee, 38163, United States

Location

Urology of Virginia, PC

Virginia Beach, Virginia, 23462, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Swedish Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• Beer TM, Schellhammer PF, Corman JM, Glode LM, Hall SJ, Whitmore JB, Frohlich MW, Penson DF. Quality of life after sipuleucel-T therapy: results from a randomized, double-blind study in patients with androgen-dependent prostate cancer. Urology. 2013 Aug;82(2):410-5. doi: 10.1016/j.urology.2013.04.049.

  PMID: 23896100 DERIVED

Related Links

• USTOO International

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Interventions

sipuleucel-T

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Shabnam Vaziri
• Organization: Dendreon

svaziri@Dendreon.com

206-455-2323

Study Officials

• Robert Israel, MD

  Valeant Pharmaceuticals North America LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2008
• First Posted: October 24, 2008
• Study Start: October 1, 2001
• Primary Completion: August 1, 2006
• Study Completion: May 1, 2015
• Last Updated: January 29, 2018
• Results First Posted: January 29, 2018

Record last verified: 2017-06

Locations

US (18)