ideasIdea
Prostate active surveillance without scheduled biopsies: MRI and blood tests decide
Men on surveillance for prostate cancer have repeat biopsies every year or two, which puts many off. Using MRI, PSA density and new markers to trigger biopsy only when needed could be just as safe.
PRECISE MRI criteria and PSA density predict progression; scheduled biopsies mostly find unchanged disease. Propose a non-inferiority RCT of biomarker/MRI-triggered biopsy versus protocol biopsy, with metastasis-free survival at eight years and biopsies per patient as endpoints.
Hypothesis
Triggered biopsy reduces biopsies by at least 60% with metastasis-free survival non-inferior (margin 2 percentage points).
Rationale
Biopsy burden drives men to choose surgery; MRI stability has high negative predictive value.
What would test it
2,000-man multicentre RCT.
Maturity
early clinical
Who has to act
clinic
Cost to try
Medium ($1M to $50M)
Years to first evidence
6
Bottlenecks it attacks
- Overdiagnosis and false alarms · Finding more cancer is not the same as saving lives. Screening also finds cancers that would never have hurt anyone, and treats them.
- Toxicity and quality of life are undervalued · Trials measure how long people live, not how they live. Side-effects are under-reported and under-treated.