A Phase 1b Adaptive Androgen Deprivation Therapy Trial in Metastatic Castration Sensitive Prostate Cancer.

Autor: Zhang J; Department of Genitourinary Oncology, Moffitt Cancer Center and Research Institute, Tampa, FL 33612, USA., Gallaher J; Department of Integrated Mathematical Oncology, Moffitt Cancer Center and Research Institute, Tampa, FL 33612, USA., Cunningham JJ; Fralin Biomedical Research Institute at Virginia Tech, Roanoke, VA 24016, USA., Choi JW; Department of Radiology, Moffitt Cancer Center and Research Institute, Tampa, FL 33612, USA., Ionescu F; Department of Oncological Science, Moffitt Cancer Center and Research Institute, Tampa, FL 33612, USA., Chatwal MS; Department of Genitourinary Oncology, Moffitt Cancer Center and Research Institute, Tampa, FL 33612, USA., Jain R; Department of Genitourinary Oncology, Moffitt Cancer Center and Research Institute, Tampa, FL 33612, USA., Kim Y; Department of Biostatistics and Bioinformatics, Moffitt Cancer Center and Research Institute, Tampa, FL 33612, USA., Wang L; Department of Tumor Biology, Moffitt Cancer Center and Research Institute, Tampa, FL 33612, USA., Brown JS; Department of Integrated Mathematical Oncology, Moffitt Cancer Center and Research Institute, Tampa, FL 33612, USA., Anderson AR; Department of Integrated Mathematical Oncology, Moffitt Cancer Center and Research Institute, Tampa, FL 33612, USA., Gatenby RA; Department of Integrated Mathematical Oncology, Moffitt Cancer Center and Research Institute, Tampa, FL 33612, USA.; Department of Radiology, Moffitt Cancer Center and Research Institute, Tampa, FL 33612, USA.
Jazyk: angličtina
Zdroj: Cancers [Cancers (Basel)] 2022 Oct 25; Vol. 14 (21). Date of Electronic Publication: 2022 Oct 25.
DOI: 10.3390/cancers14215225
Abstrakt: Background: We hypothesize that cancer survival can be improved through adapting treatment strategies to cancer evolutionary dynamics and conducted a phase 1b study in metastatic castration sensitive prostate cancer (mCSPC). Methods: Men with asymptomatic mCSPC were enrolled and proceeded with a treatment break after achieving > 75% PSA decline with LHRH analog plus an NHA. ADT was restarted at the time of PSA or radiographic progression and held again after achieving >50% PSA decline. This on-off cycling of ADT continued until on treatment imaging progression. Results: At data cut off in August 2022, only 2 of the 16 evaluable patients were off study due to imaging progression at 28 months from first dose of LHRH analog for mCSPC. Two additional patients showed PSA progression at 12.4 and 20.5 months and remain on trial. Since none of the 16 patients developed imaging progression at 12 months, the study succeeded in its primary objective of feasibility. The secondary endpoints of median time to PSA progression and median time to radiographic progression have not been reached at a median follow up of 26 months. Conclusions: It is feasible to use an individual’s PSA response and testosterone levels to guide intermittent ADT in mCSPC.
Databáze: MEDLINE
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