1: mpMRI before biopsy could spare a quarter of men from biopsy and improves detection of significant cancer

The long awaited publication of the PROMIS trial confirmed results announced at ASCO in June last year: multi-parametric MRI (mpMRI or MP-MRI) is a robust diagnostic tool and can be used to effectively triage men. The multi-centred study published in The Lancet involved 576 men and compared mpMRI to standard of care TRUS biopsy (12 cores) and gold standard template mapping biopsy (60-70 cores). mpMRI had a sensitivity of 93% compared to 48% for TRUS, meaning it is almost twice as likely to detect clinically significant cancer (Gleason ≥ 4+3 or core length ≥6mm). One of the strengths of mpMRI is that it does not detect clinically insignificant cancer and therefore could reduce biopsies by 27%. In addition, if mpMRI images are used to target biopsies, it could reduce over-detection of clinically insignificant cancer by 21% and increase detection of significant cancer by 18%. As the specificity of mpMRI alone is only 41%, biopsy is still required to confirm a diagnosis of prostate cancer. We are working with health bodies across the UK to ensure that we have not only enough scanners but the appropriate training and reporting standards in place in order to increase the number of men who have access to high-quality mpMRI before biopsy. Read more about our work on mpMRI here. 

2: Number of docetaxel cycles associated with increased survival

A post-hoc analysis published in JAMA Oncology has shown that men with metastatic castration resistant prostate cancer (mCRPC) had higher overall survival (OS) if they received more than 10 cycles of docetaxel compared to men who received 8-10 cycles or 5-7 cycles. This study analysed data from the MAINSAIL phase III randomised trial which investigated if outcomes improved when lenalidomide was added to a standard of care regimen of docetaxel plus prednisone (DP). MAINSAIL was stopped early when patients in the lenalidomide arm (DPL) experienced higher toxicity and lower OS compared to the DP arm. The current analysis indicates that the number of cycles of docetaxel that men received was an independent prognostic indicator factor for OS both overall and in separate analysis of the DP or DPL arms. Median OS for patients receiving >10, 8-10 and 5-7 cycles was 33.0, 26.9 and 22.8 months respectively. These results suggest that docetaxel should continue beyond 6 and possibly beyond 10 cycles if well tolerated. Following on the results of STAMPEDE, docetaxel is now prescribed in combination with ADT as first-line treatment for men with metastatic hormone sensitive prostate cancer. Whether additional cycles of docetaxel are also beneficial for men with hormone sensitive metastatic disease will be an important question for future research.

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3: Immunotherapy treatment ipilimumab does not improve survival in men with mCRPC

Results from a phase III randomised trial show that using ipilimumab as a front line agent for men with chemotherapy naïve, non-visceral, mCRPC does not improve median overall survival (28.7 months) compared to placebo (29.7 months); HR 1.11; p=0.37. Ipilimumab has demonstrated significant survival benefits and has been approved for treatment in melanoma. The lack of survival benefit seen in this trial may be partially due to the increased side effects in the treatment arm. 31% of men in the ipilimumab arm had grade 3 to 4 immune-related adverse effects compared to 2% of men in the control arm. Furthermore, 2% of men in the ipilimumab arm died of treatment-related adverse effects, while there were no deaths in the control arm. Despite this, men in the treatment arm had longer progression free survival (5.6 months versus 3.8 months for placebo treatment) and prostate specific antigen (PSA) response rate (23% versus 8% for placebo treatment) suggesting, that while not effective in an unselected population, ipilimumab has antitumour activity and may benefit a subset of patients. Future work will be important to identify this subset of men who may benefit and to test newer immunotherapies which may have a milder side effect profile.

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