Dendreon Pharmaceuticals is set to conduct the new PROVENT clinical trial to examine the effectiveness of Provenge (sipuleucel-T) in preventing disease progression in men with prostate cancer on active surveillance (AS).
The randomised, double-blind, placebo-controlled, multi-centre trial will be carried out at around 50 sites across the US.
During the trial, around 450 men aged 18 or older who have histologically proven adenocarcinoma of the prostate diagnosed within 12 months of randomisation, will be randomised at a 2:1 ratio to receive Provengeor placebo.
The primary objective of ProVent is to evaluate the efficacy of Provengein reducing histopathologic disease progression in men on AS.
Secondary endpoints of the trial comprise the number of study participants with subsequent prostate cancer treatment such as surgery, radiation, hormone therapy, the percentage of participants with a negative biopsy, and safety.
The trial’s exploratory objectives will examine the association of immunologic responses with efficacy and patient quality of life outcomes.
It aims to begin patient enrolment within this year and plans to release topline results by 2023.
Dendreon Pharmaceuticals CEO Jim Caggiano said: “Dendreon led the way with Provenge, the first active cellular immunotherapy approved by the Food and Drug Administration (FDA).
“We have already established that PROVENGE helps mCRPC patients live longer, and physicians have prescribed it to over 30,000 men.
“With this trial, Dendreon is taking another leadership position in the treatment of prostate cancer; if successful, it could again revolutionise the way the disease is treated.”
According to the American Cancer Society, around 165,000 men are diagnosed with prostate cancer annually.
Nearly 30% to 40% of the prostate cancer patients opt for AS, which includes regular monitoring to ensure the cancer is not growing or spreading instead of undergoing more aggressive treatments, noted Johns Hopkins Medicine in the US.