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

Conditions

• Metastatic Prostate Cancer
• Prostate Cancer

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 1-(4-(2-Fluoroethoxy)phenyl)-8,9-dihiydro-2,7,9a-triazabenzo[cd]azulen-6(7H)-one — DRUG
  \[18F\]fluorthanatrace (FTT) is a positron emitting radiopharmaceutical that is administered as an intravenous (IV) solution via injection at a prescribed dose of 10mCi. A lesser dose may be injected if complete imaging data could be generated.
• FTT-PET/CT — DEVICE
  A small intravenous (IV) catheter will be placed in the arm vein according to site's standard practice to allow injection of FTT. Approximately sixty minutes following administration of approximately 10 mCi of the radiotracer FTT, patients will undergo standard body PET/CT imaging.
• EnhanceAR-Seq — DIAGNOSTIC_TEST
  Patients will undergo approximately 30 mL of peripheral blood sample collection to be used for analysis. For each sample, EnhanceAR-Seq will be performed on each of these samples, with somatic genomic alteration calling performed in plasma cell-free DNA with removal of background non-tumor variants using matched plasma-depleted whole blood germline samples.

Study Details

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.

Key Dates

First listed

Jul 23, 2026

Start date

Sep 1, 2026

Status verified

Jul 2026

Primary completion

Mar 31, 2032

Completion

Mar 31, 2032

Study Design

Enrollment

75 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• Experimental: FTT-PET/CT
  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.

Primary Outcome Measure

Prediction performance of FTT-PET as measured by concordance index (C-index) [ Time Frame: At baseline prior to PARPi therapy and post cycle 1 (estimated total time 28 days) ]

Central Contacts

• Farrokh Dehdashti, MD
  314-362-1474
  [email protected]

Locations (3)

Find similar trials in St Louis, MO

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