[18F]Fluorthanatrace - Positron Emission Tomography (FTT-PET) and ctDNA to Predict Response to PARP Inhibitor Therapy in Metastatic Prostate... | NCT07723651

NCT07723651

Overview

NCT ID: NCT07723651
Lead Sponsor: Washington University School of MedicineOTHER
Official Title: Integration of FTT-PET and ctDNA to Predict Response to PARP Inhibitor Therapy in Metastatic Prostate Cancer (mPC)
Brief Summary: 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.
Conditions: Metastatic Prostate Cancer
Prostate Cancer

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 23, 2026Actual
Start Date: Sep 1, 2026Estimated
Primary Completion Date: Mar 31, 2032Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Male
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Adult male patients 18 years of age or older

mCRPC with confirmed germline or somatic HRR (such as ATM, ATR, BRCA1, BRCA2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, or RAD51C for Talazoparib/enzalutamide and ATMm, BRCA1m, BRCA2m, BARD1m, BRIP1m, CDK12m, CHEK1m, CHEK2m, FANCLm, PALB2m, RAD51Bm, RAD51Cm, RAD51Dm, RAD54Lm; gBRCA1m, gBRCA2m; ATMm, BRCA1m, BRCA2m for Olaparib +/- abiraterone) mutations who are scheduled for SOC PARPi therapy.

Lesion size of at least 1.0 cm in longest dimension by imaging. If non-measurable, lesion needs to be clearly detected on other imaging studies such as bone scintigraphy, FDG-PET, PSMA-PET or MRI.

On continuous androgen deprivation therapy (ADT) with appropriately suppressed castrate testosterone levels of < 50 ng/dL, or prior bilateral orchiectomy.

Serum PSA of 2 ng/mL or greater.

Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

Able to give informed consent

Exclusion Criteria:

Receipt of prior PARP inhibitor therapy in any disease setting.

Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer that is active at the time of enrollment.

Unable to tolerate approximately 30 min (total time) of PET/CT imaging.

Study Plan

Study Type: Interventional
Phase: Phase 2
Enrollment: 75Estimated
Primary Purpose: Diagnostic
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Farrokh Dehdashti, MDContact
dehdashtif@wustl.edu314-362-1474

Similar Studies

Participant Group/Arms

FTT-PET/CTExperimental

Participants will undergo two FluorThanatrace (FTT) Positron Emission Tomography/Computed tomography (PET/CT) scans; one at baseline prior to starting standard of care (SOC) PARP inhibitor (PARPi) therapy and one two weeks after initiation of PARPi therapy. Each cycle of PARPi therapy is 28 days. Blood samples for EnhanceAR-Seq ctDNA analysis will be collected from participants at baseline prior to therapy, post cycle 1,12 weeks after PARPi initiation, and at time of disease progression. Eight participants will undergo an additional FTT-PET/CT prior to initiation of PARPi therapy.

Drug: 1-(4-(2-Fluoroethoxy)phenyl)-8,9-dihiydro-2,7,9a-triazabenzo[cd]azulen-6(7H)-one

Device: FTT-PET/CT

Diagnostic Test: EnhanceAR-Seq

Locations

Washington University School of Medicine

St Louis, Missouri 63110, United States

Farrokh Dehdashti, MDContact

dehdashtif@wustl.edu314-362-1474

Kooresh I Shoghi, PhDSub-Investigator

Christopher A Maher, PhDSub-Investigator

Richard Laforest, PhDSub-Investigator

Cody Weimholt, MDSub-Investigator

Melissa A Reimers, MDSub-Investigator

Yu Tao, MDSub-Investigator

Buck Rogers, PhDSub-Investigator

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania 19104, United States

University of Texas MD Anderson Cancer Center

Houston, Texas 77030, United States