This multicenter center, open-label, baseline-controlled diagnostic imaging study designed to assess the use of Fluorthanatrace-Positron Emission tomography (FTT-PET) as a PARP inhibitor (PARPi) therapy predictive imaging biomarker and the use of EnhanceAR-Seq (ctDNA) in predicting response to therapy and to identify genomic alterations associated with resistance. Furthermore, to correlate changes in ctDNA and imaging (FTT-PET and standard of care imaging) to understand the dynamics of tumor response.
Age range
18 Years
Sex
MALE
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Prediction performance of FTT-PET as measured by concordance index (C-index)
Timeframe: At baseline prior to PARPi therapy and post cycle 1 (estimated total time 28 days)
Prediction performance of FTT-PET as measured by area under the receiver operating characteristic (ROC) curve
Timeframe: At baseline prior to PARPi therapy and post cycle 1 (estimated total time 28 days)
Prediction performance of EnhanceAR-Seq ctDNAas measured by concordance index (C-index)
Timeframe: At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)
Prediction performance of EnhanceAR-Seq ctDNA as measured by area under the receiver operating characteristic (ROC) curve
Timeframe: At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)
Prediction performance of FTT-PET and EnhanceAR-Seq ctDNA collectively as measured by concordance index (C-index)
Timeframe: At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), and at progression if applicable (estimated total time 6 months)
Prediction performance of FTT-PET and EnhanceAR-Seq ctDNA collectively as measured by area under the receiver operating characteristic (ROC) curve
Timeframe: At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), and at progression if applicable (estimated total time 6 months)
Sensitivity of EnhanceAR-Seq ctDNA in identifying mPC patients who respond to PARPi therapy
Timeframe: At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)
Specificity of EnhanceAR-Seq ctDNA in identifying mPC patients who respond to PARPi therapy
Timeframe: At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)
Positive predictive value (PPV) of EnhanceAR-Seq ctDNA in identifying mPC patients who respond to PARPi therapy
Timeframe: At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)
Negative predictive value (NPV) of EnhanceAR-Seq ctDNA in identifying mPC patients who respond to PARPi therapy
Timeframe: At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)
Predictive performance improvement as measured by change in concordance index of FTT-PET and EnhanceAR-seq ctDNA compared to only FTT-PET or only EnhanceAR-seq ctDNA
Timeframe: At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)
Predictive performance improvement as measured by area under the receiver operating characteristic (ROC) curve of FTT-PET and EnhanceAR-seq ctDNA compared to only FTT-PET or only EnhanceAR-seq ctDNA
Timeframe: At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)