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

This study is currently recruiting participants.
Verified November 2017 by Abramson Cancer Center of the University of Pennsylvania
Sponsor:
ClinicalTrials.gov Identifier:
NCT03334500
First Posted: November 7, 2017
Last Update Posted: November 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
  Purpose
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.

Condition Intervention Phase
Prostate Cancer Device: [18F]FluorThanatrace ([18F]FTT) Drug: PARP-1 Early Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating in Vivo PARP-1 Expression With 18F-FluorThanatrace Positron Emission Tomography (PET/CT) in Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • Number of adverse events [ Time Frame: 3 years ]

Estimated Enrollment: 30
Actual Study Start Date: July 14, 2017
Estimated Study Completion Date: July 14, 2021
Estimated Primary Completion Date: July 14, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1 Gleason 6 (n=10) Device: [18F]FluorThanatrace ([18F]FTT)
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.
Drug: PARP-1
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.
Experimental: Cohort 2 Gleason 7-8 (n=10) Device: [18F]FluorThanatrace ([18F]FTT)
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.
Drug: PARP-1
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.
Experimental: Cohort 3 Gleason 9 or oligometastic disease (n=10) Device: [18F]FluorThanatrace ([18F]FTT)
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.
Drug: PARP-1
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants will be ≥ 18 years of age
  • Biopsy proven prostate cancer
  • Must meet one of the following criteria:

    1. At least two tissue cores containing at least 50% tumor (per pathology report) OR
    2. 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03334500


Contacts
Contact: Dan Pryma, MD 855-216-0098 PennCancerTrials@emergingmed.com

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Dan Pryma, MD    855-216-0098    PennCancerTrials@emergingmed.com   
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
Principal Investigator: Dan Pryma, MD Abramson Cancer Center of the University of Pennsylvania
  More Information

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03334500     History of Changes
Other Study ID Numbers: UPCC 13817
First Submitted: November 3, 2017
First Posted: November 7, 2017
Last Update Posted: November 7, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases