INTENSIFY
Research type
Research Study
Full title
A phase III open label randomised trial of androgen deprivation therapy plus androgen receptor pathway inhibition, with or without docetaxel intensification, in metastatic prostate cancer with a PSA ≥0.2 ng/ml at 6 months (INTENSIFY)
IRAS ID
1010677
Contact name
Anna Song
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
ISRCTN Number
ISRCTN17215075
Research summary
Prostate cancer is incurable when it has spread to other parts of the body (called metastatic prostate cancer). Metastatic prostate cancer is initially managed with hormonal treatments. The most common first treatment option used for men in the UK is hormonal injections (androgen deprivation therapy, ADT) combined with hormonal tablets (an androgen receptor targeted agent, ARTA), known as a doublet
therapy.A blood test for a protein called prostate specific antigen (PSA) is routinely used for monitoring patients to check whether their prostate cancer is responding treatment. Almost all men have a reduction in their PSA result after starting their treatment. However, how far the PSA falls after treatment starts is a strong indicator of longer term outcomes. Multiple studies have shown that if the PSA falls, but still remains
above 0.2 ng/ml, after about 6 months of treatment with hormones, then the outcomes (such as survival) tend to be worse.This clinical trial, called INTENSIFY, is for men with metastatic hormone sensitive prostate cancer who have a PSA that remains above 0.2 ng/ml after 6 months of hormonal treatment. We will test if they survive longer if we add chemotherapy to their treatment earlier than otherwise planned.
INTENSIFY will recruit 518 patients with prostate cancer, where the PSA falls but still remains above 0.2 ng/ml, after 6 months of doublet hormonal therapy. Patients who choose to take part will be randomly selected to receive one of two possible treatment options:1. Standard of care treatment - continue doublet hormonal therapy (ADT +ARTA);2.Experimental treatment - continue doublet hormonal therapy plus chemotherapy. Chemotherapy will be with a drug called docetaxel given through a drip at the hospital outpatient treatment unit every 3 weeks for up to 6 treatments. This is a chemotherapy drug that has been used to treat different cancers for many years, including prostate cancer.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
25/WM/0250
Date of REC Opinion
7 Jan 2026
REC opinion
Further Information Favourable Opinion