Prostate Cancer MetastaticEarly Phase 1NCT05242744
FTT PET/CT in Metastatic Prostate Cancer
A Early Phase 1 study testing [18F]FluorThanatrace in people with Prostate Cancer Metastatic, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Metastatic
- What is being tested?
- [18F]FluorThanatrace
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to Jul 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104
Erin Schubert, 215-573-6569 ext. 2155736569, erin.schubert@pennmedicine.upenn.edu
Neil Taunk, MD
About this study
Official title: Evaluating in Vivo PARP-1 Expression With 18F-FluorThanatrace Positron Emission Tomography (PET/CT) in Patients With Metastatic Prostate Cancer
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.
Read the detailed description
Up to 30 evaluable 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 will be enrolled in this study. A pre-treatment 18F-FluorThanatrace ([18F]FTT) positron emission tomography/ computed tomography (PET/CT) scan will be done prior to the start of a new therapy regimen. PET/CT imaging will be used to evaluate PARP-1 expression in sites of prostate cancer using the investigational radiotracer [18F]FTT. This is an observational study in that [18F]FTT PET/CT will not be used to direct treatment decisions. While patients and referring physicians will not be blinded to the [18F]FTT PET/CT results, treatment decisions will be made by the treating physicians based upon clinical criteria. After injection of [18F]FTT patients will undergo a skull base to mid-thigh scan, starting at approximately 60 minutes post injection. PET/CT imaging sessions will include an injection of 12 mCi of [18F]FTT intravenously (approximate range for most studies is anticipated to be 8-12 mCi ). of [18F] FTT. Data will be collected to evaluate uptake of [18F]FTT in sites of prostate cancer, which will be compared with PARP-1 expression in tissue, when available. All evaluable patients may start new therapy following the [18F]FTT PET/CT scan. It is expected that due to patient preference and time considerations, approximately 80% will also undergo a second (optional) scan that will be performed approximately 1-21 days after new therapy has started. The second scan is obtained to evaluate whether the initiation of a PARP inhibitor and/or androgen deprivation therapy and/or chemotherapy alters [18F] FTT uptake.
- Conditions
- Prostate Cancer Metastatic
- Being tested
- [18F]FluorThanatrace
- Keywords
- PET/CT, PARP inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]FluorThanatraceDrug
Also called [18F]FTT
Investigational radiopharmaceutical used with Positron Emission Tomography (PET/CT) imaging that may provide a non-invasive measurement of PARP-1 expression
| Study group | Role | What they receive |
|---|---|---|
| Metastatic prostate cancer | Experimental | 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. Receives: Drug: [18F]FluorThanatrace |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 21 days
Secondary outcomes (4)
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
Measured: 21 days
Correlation with PARP-1 IHC
Correlation of [18F]FTT uptake measures with PARP-1 IHC expression in the tissue specimen, when available
Measured: 6 months
Correlation with PARP-1 autoradiography
Correlation of [18F]FTT uptake measures with PARP-1 [125I]KX1 autoradiography expression in the tissue specimen, when available
Measured: 6 months
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start1 Mar 2023
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neil Taunk, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242744
- Sponsor's protocol ID
- UPCC 08821
- Other IDs
- 849671
- Status last verified
- Oct 2026
- First submitted
- 8 Feb 2022
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating in Vivo PARP-1 Expression With 18F-FluorThanatrace Positron Emission Tomography (PET/CT) in Patients With Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT05242744
- Acronym / sponsor ID
- UPCC 08821
- Conditions
- Prostate Cancer Metastatic
- Keywords
- PET/CT, PARP inhibitor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 16 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Up to 30 evaluable 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 will be enrolled in this study. A pre-treatment 18F-FluorThanatrace ([18F]FTT) positron emission tomography/ computed tomography (PET/CT) scan will be done prior to the start of a new therapy regimen. PET/CT imaging will be used to evaluate PARP-1 expression in sites of prostate cancer using the investigational radiotracer [18F]FTT. This is an observational study in that [18F]FTT PET/CT will not be used to direct treatment decisions. While patients and referring physicians will not be blinded to the [18F]FTT PET/CT results, treatment decisions will be made by the treating physicians based upon clinical criteria. After injection of [18F]FTT patients will undergo a skull base to mid-thigh scan, starting at approximately 60 minutes post injection. PET/CT imaging sessions will include an injection of 12 mCi of [18F]FTT intravenously (approximate range for most studies is anticipated to be 8-12 mCi ). of [18F] FTT. Data will be collected to evaluate uptake of [18F]FTT in sites of prostate cancer, which will be compared with PARP-1 expression in tissue, when available. All evaluable patients may start new therapy following the [18F]FTT PET/CT scan. It is expected that due to patient preference and time considerations, approximately 80% will also undergo a second (optional) scan that will be performed approximately 1-21 days after new therapy has started. The second scan is obtained to evaluate whether the initiation of a PARP inhibitor and/or androgen deprivation therapy and/or chemotherapy alters [18F] FTT uptake.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic prostate cancer | Experimental | Drug: [18F]FluorThanatraceMen 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]FluorThanatraceAlso: [18F]FTTInvestigational radiopharmaceutical used with Positron Emission Tomography (PET/CT) imaging that may provide a non-invasive measurement of PARP-1 expression | Drug | Metastatic prostate cancer |
Primary outcome
Measurement of effect size
Time frame: 21 days
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)
4 secondary outcomes
Evaluation of PARP expression
Time frame: 21 days
Correlation with PARP-1 IHC
Time frame: 6 months
Correlation with PARP-1 autoradiography
Time frame: 6 months
Predication of clinical response
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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RecruitingPhase 2
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Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neil Taunk, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [18F]FluorThanatrace in people with Prostate Cancer Metastatic, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Schubert, BA (215-573-6569, erin.schubert@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of effect size (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.