Health TrialsbyHealthPanel

FTT PET/CT in Metastatic Prostate Cancer

ConditionProstate Cancer Metastatic
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorAbramson Cancer Center at Penn Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • [18F]FluorThanatrace

    Drug

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Metastatic prostate cancer1 intervention

Trial outcomes

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)

Time frame
21 days

Secondary outcomes

1

Evaluation of PARP expression

Evaluation of PARP-1 expression in prostate cancer using measures of uptake of \[18F\]FTT before and after PARPi and/or androgen deprivation therapy and/or chemotherapy

Time frame
21 days
2

Correlation with PARP-1 IHC

Correlation of \[18F\]FTT uptake measures with PARP-1 IHC expression in the tissue specimen, when available

Time frame
6 months
3

Correlation with PARP-1 autoradiography

Correlation of \[18F\]FTT uptake measures with PARP-1 \[125I\]KX1 autoradiography expression in the tissue specimen, when available

Time frame
6 months
4

Predication of clinical response

Determination of whether baseline and/or pre-/post-treatment changes in \[18F\]FTT uptake predict clinical response as measured by progression-free survival (PFS) and anatomic criteria on standard of care imaging

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abramson Cancer Center at Penn Medicine

Lead sponsor

Source ClinicalTrials.gov
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