[18F]Fluorthanatrace - Positron Emission Tomography (FTT-PET) and ctDNA to Predict Response to PARP Inhibitor Therapy in Metastatic Prostate Cancer (mPC)
Integration of FTT-PET and ctDNA to Predict Response to PARP Inhibitor Therapy in Metastatic Prostate Cancer (mPC)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official 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 sites (3)
MO
- Washington University School of Medicine · St Louis, MO 63110Farrokh Dehdashti, MD · Study contact · 314-362-1474 · dehdashtif@wustl.eduKooresh I Shoghi, PhD · Sub-investigatorChristopher A Maher, PhD · Sub-investigatorRichard Laforest, PhD · Sub-investigatorMore trials in St Louis
PA
- University of Pennsylvania Abramson Cancer Center · Philadelphia, PA 19104Nei Taunk, MD · Study contact · 215-662-6515 · taunk@upenn.eduNei Taunk, MD · Principal investigatorMore trials in Philadelphia
TX
- University of Texas MD Anderson Cancer Center · Houston, TX 77030Lilie Lin, MD · Study contact · 713-792-2121Lilie Lin, MD · Principal investigatorFranklin Wong, MD · Sub-investigatorPatrick G Pilie, MD · Sub-investigatorMore trials in Houston