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

Primary Purpose

Prostate Cancer

Status

Active

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

[18F]FluorThanatrace

Poly(ADP Ribose) Polymerase 1

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Abramson Cancer Center of the University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Arm Description

Gleason 6 (n=10)

Gleason 7-8 (n=10)

Gleason 9 or oligometastic disease (n=10)

Outcomes

Primary Outcome Measures

Number of adverse events

Secondary Outcome Measures

Full Information

NCT ID

NCT03334500

First Posted

November 3, 2017

Last Updated

August 1, 2023

Sponsor

Abramson Cancer Center at Penn Medicine

1. Study Identification

Unique Protocol Identification Number

NCT03334500

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 14, 2017 (Actual)

Primary Completion Date

December 2025 (Anticipated)

Study Completion Date

December 16, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abramson Cancer Center at Penn Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1

Arm Type

Experimental

Arm Description

Gleason 6 (n=10)

Arm Title

Cohort 2

Arm Type

Experimental

Arm Description

Gleason 7-8 (n=10)

Arm Title

Cohort 3

Arm Type

Experimental

Arm Description

Gleason 9 or oligometastic disease (n=10)

Intervention Type

Device

Intervention Name(s)

[18F]FluorThanatrace

Other Intervention Name(s)

18F-FTT

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Poly(ADP Ribose) Polymerase 1

Other Intervention Name(s)

PARP 1

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of adverse events

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dan Pryma, MD

Organizational Affiliation

Abramson Cancer Center at Penn Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Abramson Cancer Center of the University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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