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Active, Not Recruiting

NCT Number: NCT03334500

Evaluating in Vivo PARP-1 Expression With 18F-FluorThanatrace Positron Emission Tomography (PET/CT) in Prostate Cancer

Men with a history of prostate cancer may be in this study. Subjects recommended for a prostatectomy or oligometastectomy will undergo PET/CT imaging using a novel radiotracer [18F]FTT to evaluate PARP-1 activity in known or suspected sites of primary or metastatic disease. Imaging will be compared with pathology results, including additional research assays when possible.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants will be ≥ 18 years of age
  • Biopsy proven prostate cancer
  • Must meet one of the following criteria:
  • At least two tissue cores containing at least 50% tumor (per pathology report) OR
  • At least one lesion that is 1 cm or greater in size by standard imaging (e.g. ultrasound, MRI, CT). Only one type of imaging is required to show a lesion of 1 cm or greater in order for the patient to be eligible to participate in this study.
  • Recommended for clinically indicated radical prostatectomy or oligometastectomy
  • Willing to allow use or collection of pathology tissue for the purposes of research from either clinical biopsy or surgical procedure (if adequate tissue is available)
  • Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.

Exclusion criteria

  • Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
  • Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
  • Only individuals (aged 18 or over) who can understand and give informed consent will be approached to participate in this study. Individuals who are considered to be mentally disabled will not be recruited for this study. All subjects must understand and be able to give informed consent. We will not be using specific methods to assess decisional capacity. Economically disadvantaged persons will not be vulnerable to undue influence, as this study offers no compensation. All individuals will be told that their choice regarding study participation will in no way change their access to clinical care. This should negate any undue influence or coercion. Women, children, fetuses, neonates, or prisoners are not included in this research study.

Treatment and study plan

[18F]FluorThanatrace

Device

Fluorine-18 labeled FluorThanatrace [18F]FTT can be synthesized with high specific activity so the quantity of mass injected with the radiopharmaceutical is < 10 μg.

Other names: 18F-FTT

Poly(ADP Ribose) Polymerase 1

Drug

Poly(ADP-ribose) polymerase (PARP) is a family of enzymes involved in base excision repair (the repair of DNA single-strand breaks) and alternative end joining (repair of DNA double-strand breaks). The molecular basis of PARP1 inhibitor function may depend on the dual roles of PARP1 as a modulator of gene transcription in addition to DNA damage repair 3.

Other names: PARP 1

Primary outcomes

  1. Number of adverse events

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Nov 7, 2017
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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