Last updated on November 2019

Randomized MRI-Guided Prostate Boosts Via Initial Lattice Stereotactic vs Daily Moderately Hypofractionated Radiotherapy

Brief description of study

The BLaStM clinical trial extends the Phase I LEAD trial and compares the LEAD SBRT upfront technique for increasing dose to the MP-MRI defined GTVs, to the HEIGHT method of using a moderate hypofractionated simultaneous integrated boost to the MP-MRI defined GTVs through the course of radiotherapy. The hypothesis is that alternate mechanisms of cell death, including bystander effects, are put in place when doses above 8 Gy per fraction are used in a lattice on the first day of treatment and that the effects on local tumor eradication will be greater using this strategy.

Detailed Study Description

Radiotherapy (RT) is a commonly applied primary (initial definitive) treatment alternative to prostatectomy that allows for preservation of anatomy and the potential for improved functional outcome with better tumor targeting and normal tissue sparing. About 30-50% of men ultimately develop biochemical failure (BF) after RT, depending on risk factors. Persistence of disease in the dominant lesion is indicated to be a common mechanism responsible for progression. Prostate cancer has a long natural history. BF typically precedes clinical progression to metastasis by many years and local persistence has been implicated. While survival at 10 years is high overall, quality of life is affected by failure of any kind. Pathologic complete response (PathCR) by standard ultrasound guided systematic prostate biopsies at 2-3 years after RT is the strongest post-treatment (post-Tx) predictor of patient outcome yet identified. Multiparametric-MRI (MP-MRI) parameters identify dominant tumor areas in the prostate with a fairly high sensitivity and specificity, and MP-MRI directed biopsies should, therefore, further strengthen the association between prostate biopsy results and patient outcome.

The proposed research compares two previously explored methods (LEAD and HEIGHT) for escalating dose to MP-MRI defined prostate regions directly and addresses the goals of 1) improving local control via targeted radiotherapy (RT) dose escalation to the MP-MRI defined high risk (dominant) tumor areas using PathCR based on MP-MRI-directed biopsies at 2-2.5yr after treatment as the primary endpoint; 2) preserving quality of life by minimizing dose to the nearby organs at risk around the prostate; and 3) establishing the relationship of preand serial post-Tx MP-MRI parameters to PathCR.

Clinical Study Identifier: NCT02307058

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