PROvenge Treatment and Early Cancer Treatment

Completed · Phase 3

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00779402

Run by

Dendreon

People needed

176

Starts

2001-10-01

Expected to finish

2015-05-01

Last updated by the study team

2018-01-29

Who can join

Age: 18 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may not qualify if…

• Exclusion Criteria for Entry into the Run-In Phase (Week -13)
• 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
• Exclusion Criteria for Randomization (Week 0):
• 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.
• Any contraindication to leukapheresis or infusion of sipuleucel-T or control.
• Positive serology for human immunodeficiency virus (HIV)-1 or 2, human lymphotropic virus (HTLV)-1 or 2, or evidence of active Hepatitis B or C infection.
• Any ongoing active bacterial, viral, or fungal infection.
• Exclusion Criteria During the Trial:
• The use of any systemic therapy for prostate cancer following randomization and prior to BF (PSA ≥ 3 ng/mL).
• Placement of radioactive seeds or salvage radiation before BF (PSA ≥ 3 ng/mL) documented.
• Initiation of systemic corticosteroids at doses greater than the equivalent of 40 mg hydrocortisone per day (inhaled steroids are allowed) before BF.

Where it is running

• Alta Bates Comprehensive Cancer Center — Berkeley, California, United States
• South Orange County Medical Research — Laguna Hills, California, United States
• University of Colorado Health Sciences Center — Aurora, Colorado, United States
• Oncology Specialists, SC — Park Ridge, Illinois, United States
• Mount Sinai School of Medicine — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• McKay Urology — Charlotte, North Carolina, United States
• AKSM Clinical Research Group — Columbus, Ohio, United States
• Providence Medical Center — Portland, Oregon, United States
• Oregon Health and Sciences University — Portland, Oregon, United States
• Oregon Urology Institute — Springfield, Oregon, United States
• Urology Health Specialists - Bryn Mawr — Bryn Mawr, Pennsylvania, United States
• Albert Einstein Medical Building — Philadelphia, Pennsylvania, United States
• Bryn Mawr Urology Group — Rosemont, Pennsylvania, United States
• University of Tennessee — Memphis, Tennessee, United States
• Urology of Virginia, PC — Virginia Beach, Virginia, United States
• Virginia Mason Medical Center — Seattle, Washington, United States
• Swedish Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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