NCT05242744

Brief Summary

Up to 30 men with metastatic prostate cancer will undergo up to 2 FTT PET/CT scans to look at PARP activity in sites of known cancer. Subjects will undergo a baseline scan prior to starting new therapy and a second, optional, post-therapy scan 1-21 days after the start of treatment. Tissue from a clinical or research biopsy will be compared to imaging measures, if available.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
2mo left

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Mar 2023Jul 2026

First Submitted

Initial submission to the registry

February 8, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 16, 2022

Completed
1 year until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

July 11, 2025

Status Verified

July 1, 2025

Enrollment Period

3.3 years

First QC Date

February 8, 2022

Last Update Submit

July 8, 2025

Conditions

Prostate Cancer Metastatic

Keywords

PET/CTPARP inhibitor

Outcome Measures

Primary Outcomes (1)

  • Measurement of effect size

    To establish effect size of change in FTT uptake before and after systemic therapy in men with prostate cancer metastasis using \[18F\]FluorThanatrace (\[18F\]FTT)

    21 days

Secondary Outcomes (4)

  • Evaluation of PARP expression

    21 days

  • Correlation with PARP-1 IHC

    6 months

  • Correlation with PARP-1 autoradiography

    6 months

  • Predication of clinical response

    1 year

Study Arms (1)

Metastatic prostate cancer

Men at least 18 years of age with metastatic prostate cancer may be eligible for this study .Volunteers that meet the eligibility criteria will be considered for study participation regardless of race or ethnic background. Only individuals who can understand and give informed consent will be eligible to participate in this study.

Drug: [18F]FluorThanatrace

Interventions

[18F]FluorThanatraceDRUG

Investigational radiopharmaceutical used with Positron Emission Tomography (PET/CT) imaging that may provide a non-invasive measurement of PARP-1 expression

Also known as: [18F]FTT
Metastatic prostate cancer

Eligibility Criteria

Age18 Years+
Sexmale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a histological diagnosis of prostate cancer with clinical evidence of metastatic disease who are being considered for new therapy or for a change in therapy with a PARP inhibitor, androgen deprivation therapy, and/or chemotherapy as part of their clinical care.

You may qualify if:

  • Participants will be ≥ 18 years of age
  • Histologically proven prostate carcinoma
  • Clinical evidence of metastatic disease with at least one lesion identified on standard of care imaging (CT, MRI, Bone Scan, FDG or other PET/CT, Ultrasound)
  • Considered a candidate for new therapy or change in therapy with PARP inhibitor therapy and/or androgen deprivation therapy (ADT) and/or chemotherapy with or without additional agents, either on a clinical trial or as part of clinical care.
  • 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.

You may not qualify if:

  • Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
  • Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Collected clinical or research pathology samples from primary or metastatic biopsy of prostate cancer. Research blood samples for future testing.

Study Officials

  • Neil Taunk, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Schubert, BA

CONTACT

215-573-6569erin.schubert@pennmedicine.upenn.edu

Ashley Veronsky, BA

CONTACT

215-898-4346ashley.veronsky@pennmedicine.upenn.edu

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2022

First Posted

February 16, 2022

Study Start

March 1, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

July 11, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)