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Abstract

Purpose: Retrospective studies suggest that metastasis-directed therapy (MDT) for oligorecurrent prostate cancer (PCa) improves progression-free survival. We aimed to assess the benefit of MDT in a randomized phase II trial.

Patients and Methods: In this multicenter, randomized, phase II study, patients with asymptomatic PCa were eligible if they had had a biochemical recurrence after primary PCa treatment with curative intent, three or fewer extracranial metastatic lesions on choline positron emission tomography-computed tomography, and serum testosterone levels > 50 ng/mL. Patients were randomly assigned (1:1) to either surveillance or MDT of all detected lesions (surgery or stereotactic body radiotherapy). Surveillance was performed with prostate-specific antigen (PSA) follow-up every 3 months, with repeated imaging at PSA progression or clinical suspicion for progression. Random assignment was balanced dynamically on the basis of two factors: PSA doubling time (≤ 3 v > 3 months) and nodal versus non-nodal metastases. The primary end point was androgen deprivation therapy (ADT)-free survival. ADT was started at symptomatic progression, progression to more than three metastases, or local progression of known metastases. 

Results: Between August 2012 and August 2015, 62 patients were enrolled. At a median follow-up time of 3 years (interquartile range, 2.3-3.75 years), the median ADT-free survival was 13 months (80% CI, 12 to 17 months) for the surveillance group and 21 months (80% CI, 14 to 29 months) for the MDT group (hazard ratio, 0.60 [80% CI, 0.40 to 0.90]; log-rank P = .11). Quality of life was similar between arms at baseline and remained comparable at 3-month and 1-year follow-up. Six patients developed grade 1 toxicity in the MDT arm. No grade 2 to 5 toxicity was observed.

Conclusion: ADT-free survival was longer with MDT than with surveillance alone for oligorecurrent PCa, suggesting that MDT should be explored further in phase III trials.

Author information

Ost P1, Reynders D1, Decaestecker K1, Fonteyne V1, Lumen N1, De Bruycker A1, Lambert B1, Delrue L1, Bultijnck R1, Claeys T1, Goetghebeur E1, Villeirs G1, De Man K1, Ameye F1, Billiet I1, Joniau S1, Vanhaverbeke F1, De Meerleer G1.

1 Piet Ost, Dries Reynders, Valérie Fonteyne, Aurélie De Bruycker, Bieke Lambert, Renée Bultijnck, Els Goetghebeur, Kathia De Man, and Gert De Meerleer, Ghent University, Ghent; Karel Decaestecker, Nicolaas Lumen, Louke Delrue, Tom Claeys, and Geert Villeirs, Ghent University Hospital, Ghent; Filip Ameye, AZ Maria Middelares, Ghent; Ignace Billiet, AZ Groeninge Kortrijk, Kortrijk; Steven Joniau, Catholic University Leuven, Leuven; and Friedl Vanhaverbeke, AZ Nikolaas, Sint-Niklass, Belgium.