Prostate CancerEarly Phase 1NCT03232164
PSMA-based 18F-DCFPyL PET/CT and PET/MRI Pilot Studies in Prostate Cancer
A Early Phase 1 study testing 18F-DCFPyL PET in people with Prostate Cancer and Prostate Neoplasm, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The overall goal of this research is to validate and develop a non-invasive imaging biomarker of prostate cancer detection, progression, and recurrence. Development of such a biomarker may be useful to differentiate indolent from aggressive prostate cancer phenotypes allowing for selection of an appropriate risk… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Neoplasm
- What is being tested?
- 18F-DCFPyL PET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2017to 1 Nov 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- Prostate cancer pathologically proven by prostate biopsy (newly diagnosed for Sub-Study 1 and 4)
- Prostate biopsy histology grade ≥ Gleason 1, 6, 3+4, or 4+3; positive biopsy >2 cores
- Any PSA permitted
- Two consecutive rising PSA values (Sub-Study 3 only)
- Castrate-levels of testosterone - total testosterone < 50 ng/dL (Sub-Study 3 only)
- Patients considered as candidates for and medically fit to undergo prostatectomy
Show all 11Show fewer
- At least 7 days after most recent prostate biopsy
- Imaging evidence of suspected metastatic disease, including CT, bone scan, MRI, ultrasound or other PET modalities (Sub-Study 3 only)
- New diagnosis of prostate cancer undergoing additional biopsy evaluation (Sub--Study 4 only)
- Karnofsky performance status of at least 70 (Sub-Study 4 only)
- General health and anatomy suitable to undergo transrectal ultrasound-MRI fusion biopsy of the identified lesions and standard 12 core sextent biopsy (Sub-Study 4 only)
Who cannot join
- Prior pelvic external beam radiation therapy or brachytherapy
- Chemotherapy for prostate cancer
- Androgen deprivation therapy for prostate cancer
- Investigational therapy for prostate cancer (Sub-Study 3 Only)
- Unable to lie flat during or tolerate PET/CT
- Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
Show all 10Show fewer
- No prostatectomy scheduled more than 12 hours post imaging (Sub-Study 1 only)
- Serum creatinine > 2 time the upper limit of normal
- Total bilirubin > 3 times the upper limit of normal
- Liver Transaminases > 5 times the upper limit of normal
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
About this study
The overall goal of this research is to validate and develop a non-invasive imaging biomarker of prostate cancer detection, progression, and recurrence. Development of such a biomarker may be useful to differentiate indolent from aggressive prostate cancer phenotypes allowing for selection of an appropriate risk adaptive therapy.
Read the detailed description
The investigators propose to evaluate a novel second-generation low-molecular-weight prostate specific membrane antigen (PSMA)-based positron emission tomography (PET) agent, 18F-DCFPyL, for detection of primary and metastatic prostate cancer. 18F-DCFPyL PET demonstrates very high tumor-to-background and tumor specific uptake which may allow for a more sensitive and accurate method for detection of early tumor recurrence and metastatic disease as compared to current PET radiotracers and current standard-of-care imaging including 99mTc-methylene diphosphonate bone scintigraphy (bone scan), contrast-enhanced computed tomography (CT) and magnetic resonance imaging (MRI).
Primary Objectives: The investigators propose to evaluate this PET agent for four different prostate cancer clinical scenarios.
- detection of clinically significant high-grade prostate cancer and initial staging
- detection of sites of recurrence in the setting of biochemical recurrence after definitive prostatectomy
- detection of advanced androgen-resistant metastatic prostate cancer, and
- detection of clinically significant prostate cancer in very low to intermediate risk primary prostate cancer
Secondary Objectives:
- Evaluate the performance of 18F-DCFPyL PET and MRI whole body DWI for detection of local-nodal and distant metastatic disease on initial staging compared to conventional imaging modalities (CT and bone scintigraphy).
- Correlate 18F-DCFPyL PET standardized-uptake values (SUV) and MRI parameters with PSMA expression by prostatectomy pathology IHC.
- Evaluate the specificity of 18F-DCFPyL PET for differentiating primary prostate cancer versus non-malignant prostate lesions (BPH, prostatitis).
- Comparison of whole body low-dose CT and whole body MRI derived PET SUV-quantitation.
- Evaluate the performance of dedicated pelvic 18F-DCFPyL PET/MRI with dynamic PET acquisition and multi-parametric MRI for differentiation of urine versus recurrent malignancy in the prostatectomy bed.
- Evaluate the contribution of whole body MRI DWI obtained from PET/MRI to improve the diagnostic performance of 18F-DCFPyL PET/CT and PET/MRI for metastatic prostate cancer lesion detection.
- Assess the quantitative accuracy of PET-derived standardized uptake value (SUV)-based parameters in 18F-DCFPyL PET obtained from PET/MRI versus PET/CT.
- Assess the quantitative reproducibility of 18F-DCFPyL PET/CT derived-SUV values in normal organ and metastatic tumor lesions.
- Evaluate the ability of 18F-DCFPyL PET to improve detection of clinically significant primary prostate cancer in men with very low to intermediate risk prostate cancer under active surveillance or watchful waiting.
Update: As of July 2022 verification, the investigators are no longer enrolling into sub-studies 1 and 2.
- Conditions
- Prostate Cancer, Prostate Neoplasm
- Being tested
- 18F-DCFPyL PET
- Keywords
- Prostate Cancer, Prostate neoplasm
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-DCFPyL PETDrug
18F-DCFPyL PET demonstrates very high tumor-to-background and tumor specific uptake which may allow for a more sensitive and accurate method for detection of early tumor recurrence and metastatic disease as compared to current PET radiotracers and current standard-of-care imaging including 99mTc-methylene diphosphonate bone scintigraphy (bone scan), contrast-enhanced computed tomography (CT) and magnetic resonance imaging (MRI).
| Study group | Role | What they receive |
|---|---|---|
| 18F-DCFPyL PET | Experimental | Four separate substudies evaluating 18F-DCFPyL PET imaging of prostate cancer in four prostate cancer clinical scenarios under the following subheadings: (1) primary prostate cancer, (2) biochemical recurrence post-prostatectomy prior to radiation therapy, (3) androgen-resistant metastatic disease and (4) detection of clinically significant prostate cancer in low to intermediate risk primary prostate cancer Receives: Drug: 18F-DCFPyL PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
18F-DCFPyL PSMA-based PET and multi-parametric MRI with DWI for Sub-Study 1: Primary Prostate Cancer
To evaluate the performance of 18F-DCFPyL PSMA-based PET and multi-parametric MRI (MP-MRI) with DWI (Diffusion Weighted Imaging) and gadolinium DCE (Dynamic Contrast Enhanced) using a dedicated PET/MRI scanner to detect clinically significant larger volume high-grade primary prostate cancer based on prostatectomy step-section pathology correlation.
Measured: one study visit (up to 3.5 hours)
Evaluate 18F-DCFPyL PSMA-based PET for localization for Sub-Study 2: Biochemical Recurrence
To evaluate the performance of 18F-DCFPyL PSMA-based PET for localization of the site of recurrent prostate cancer in men with biochemical recurrence after definitive prostatectomy with planned salvage external-beam radiation therapy (EBRT). PSA response to prostatic fossa salvage irradiation will be compared with pre-salvage 18F-DCFPyL PET uptake in the radiation field.
Measured: one study visit (up to 3.5 hours)
Compare detectability of 18F-DCFPyL for Sub-Study 3: Metastatic Androgen-Resistant Prostate Cancer
To compare the detectability of metastatic prostate cancer using 18F-DCFPyL PET obtained from PET/CT and PET/MRI compared to conventional imaging modalities (CIM) (bone scan and CT) in men with androgen-resistant prostate cancer.
Measured: up to 7 days
Sub-Study 4: Rate of positive cancer detection using PET/MRI directed MRI/transrectal ultrasound (TRUS) fusion biopsy with and without additional PSMA PET information
To evaluate the ability of 18F-DCFPyL PSMA PET to improve detection of clinically significant cancer in men with very low to intermediate risk prostate cancer using a dedicated PET/MRI.
Measured: one study visit (up to 3.5 hours)
Secondary outcomes (15)
Sub-study 1: Detection of local-nodal and distant metastatic disease (PET
Evaluate the performance of 18F-DCFPyL PET and MRI whole body DWI for detection of local-nodal and distant metastatic disease on initial staging compared to conventional imaging modalities (CT and bone scintigraphy).
Measured: one study visit (up to 3.5 hours)
Sub-Study 1: Correlation of 18F-DCFPyL PET and MRI
Correlate 18F-DCFPyL PET standardized-uptake values (SUV) and MRI parameters with PSMA expression by prostatectomy pathology IHC.
Measured: one study visit (up to 3.5 hours)
Sub-Study 1: Specificity of 18F-DCFPyL
Evaluate the specificity of 18F-DCFPyL PET for differentiating primary prostate cancer versus non-malignant prostate lesions (BPH, prostatitis).
Measured: one study visit (up to 3.5 hours)
Sub-Study 1: Low-dose CT versus MRI derived PET SUV
Comparison of whole body low-dose CT and whole body MRI derived PET SUV-quantitation.
Measured: one study visit (up to 3.5 hours)
Sub-Study 2: Detection of local-nodal and distant metastatic disease (pelvic)
Comparison of whole body 18F-DCFPyL PET with pelvic MR-MRI and whole body DWI for detection of local-nodal and distant metastatic disease on initial staging compared to conventional imaging modalities (CT and bone scintigraphy).
Measured: one study visit (up to 3.5 hours)
Sub-Study 2: Dedicated pelvic 18F-DCFPyL PET/MRI with dynamic PET acquisition and multi-parametric MRI
Evaluate the performance of dedicated pelvic 18F-DCFPyL PET/MRI with dynamic PET acquisition and multi-parametric MRI for differentiation of urine versus recurrent malignancy in the prostatectomy bed.
Measured: one study visit (up to 3.5 hours)
Sub-Study 3: Contribution of whole body MRI DWI
Evaluate the contribution of whole body MRI DWI obtained from PET/MRI to improve the diagnostic performance of 18F-DCFPyL PET/CT and PET/MRI for metastatic prostate cancer lesion detection.
Measured: Up to 7 days
Sub-Study 3: Quantitative accuracy
Assess the quantitative accuracy of 18F-DCFPyL PET standardized uptake value parameters from PET/MRI versus PET/CT.
Measured: Up to 7 days
Sub-Study 3: Quantitative reproducibility
Assess the quantitative reproducibility of 18F-DCFPyL PET/CT derived-SUV values in normal organ and metastatic tumor lesions.
Measured: Up to 7 days
Sub-study 4: Positive Detection Rate of Prostate Cancer via biopsy on PSMA PET versus mpMRI alone in very low to intermediate risk groups active surveillance and watchful waiting patients
Evaluate the positive detection rate of prostate cancer via biopsy on PSMA PET versus mpMRI alone in very low to intermediate risk groups active surveillance and watchful waiting patients.
Measured: one study visit (up to 3.5 hours)
Sub-study 4: Detection rate of clinically significant prostate cancer in men with directed MRI/US biopsy
To evaluate the ability of PSMA PET alone versus mpMRI alone versus combined PSMA PET with mpMRI to detect clinically significant prostate cancer in men with directed MRI/US biopsy.
Measured: one study visit (up to 3.5 hours)
Sub-study 4: Detection Rate of Prostate Cancer vs False Positive Findings via Biopsy
Evaluate the rate of detection of prostate cancer and false positive findings via biopsy and available prostatectomy histopathology on PSMA PET/MRI versus mpMRI alone in different prostate anatomic regions (transition, central, peripheral zones) in these risk cohorts.
Measured: one study visit (up to 3.5 hours)
Sub-study 4: Number of Participants who change treatment and surgical management plans after inclusion of PSMA-based PET directed biopsy
Assess the change in treatment and surgical management plan before and after inclusion of PSMA-based PET directed biopsy histopathology information and additional pelvic and whole body PET/MRI PET information will be obtained.
Measured: one study visit (up to 3.5 hours)
Sub-study 4: Correlation of PET and MRI parameters for PET and/or MRI positive lesions to biopsy histopathology, cancer grade group, PSA and other clinical parameters
Qualitative and quantitative PET and MRI parameters for PET and/or MRI positive lesions will be correlated with biopsy histopathology, cancer grade group, PSA and other clinical parameters.
Measured: one study visit (up to 3.5 hours)
Sub-study 4: Change in Gleason Score
PET and MRI directed biopsy histopathology prostate Gleason score range will be compared, and evaluated for Gleason score upgrading in any patients who undergo prostatectomy with available prostatectomy histopathology as the reference standard. Gleason scores range from 6-10 with higher numbers indicating higher grade cancer.
Measured: one study visit (up to 3.5 hours), post-prostatectomy (standard of care)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start2 Feb 2017
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- Model description
- Single center, open label, single-arm, pilot study
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steve Y Cho, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232164
- Sponsor's protocol ID
- UW16062
- Other IDs
- 2016-0883, A539300, NCI-2017-01643, Protocol Version 8/25/2023, Bluemke Family Trust
- Status last verified
- Dec 2024
- First submitted
- 17 Jul 2017
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PSMA-based 18F-DCFPyL PET/CT and PET/MRI Pilot Studies in Prostate Cancer
- ClinicalTrials.gov ID
- NCT03232164
- Acronym / sponsor ID
- UW16062
- Conditions
- Prostate Cancer, Prostate Neoplasm
- Keywords
- Prostate Cancer, Prostate neoplasm
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 2 Feb 2017 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 27 Jul 2017 (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.
The overall goal of this research is to validate and develop a non-invasive imaging biomarker of prostate cancer detection, progression, and recurrence. Development of such a biomarker may be useful to differentiate indolent from aggressive prostate cancer phenotypes allowing for selection of an appropriate risk adaptive therapy.
Detailed description
The investigators propose to evaluate a novel second-generation low-molecular-weight prostate specific membrane antigen (PSMA)-based positron emission tomography (PET) agent, 18F-DCFPyL, for detection of primary and metastatic prostate cancer. 18F-DCFPyL PET demonstrates very high tumor-to-background and tumor specific uptake which may allow for a more sensitive and accurate method for detection of early tumor recurrence and metastatic disease as compared to current PET radiotracers and current standard-of-care imaging including 99mTc-methylene diphosphonate bone scintigraphy (bone scan), contrast-enhanced computed tomography (CT) and magnetic resonance imaging (MRI).
Primary Objectives: The investigators propose to evaluate this PET agent for four different prostate cancer clinical scenarios.
- detection of clinically significant high-grade prostate cancer and initial staging
- detection of sites of recurrence in the setting of biochemical recurrence after definitive prostatectomy
- detection of advanced androgen-resistant metastatic prostate cancer, and
- detection of clinically significant prostate cancer in very low to intermediate risk primary prostate cancer
Secondary Objectives:
- Evaluate the performance of 18F-DCFPyL PET and MRI whole body DWI for detection of local-nodal and distant metastatic disease on initial staging compared to conventional imaging modalities (CT and bone scintigraphy).
- Correlate 18F-DCFPyL PET standardized-uptake values (SUV) and MRI parameters with PSMA expression by prostatectomy pathology IHC.
- Evaluate the specificity of 18F-DCFPyL PET for differentiating primary prostate cancer versus non-malignant prostate lesions (BPH, prostatitis).
- Comparison of whole body low-dose CT and whole body MRI derived PET SUV-quantitation.
- Evaluate the performance of dedicated pelvic 18F-DCFPyL PET/MRI with dynamic PET acquisition and multi-parametric MRI for differentiation of urine versus recurrent malignancy in the prostatectomy bed.
- Evaluate the contribution of whole body MRI DWI obtained from PET/MRI to improve the diagnostic performance of 18F-DCFPyL PET/CT and PET/MRI for metastatic prostate cancer lesion detection.
- Assess the quantitative accuracy of PET-derived standardized uptake value (SUV)-based parameters in 18F-DCFPyL PET obtained from PET/MRI versus PET/CT.
- Assess the quantitative reproducibility of 18F-DCFPyL PET/CT derived-SUV values in normal organ and metastatic tumor lesions.
- Evaluate the ability of 18F-DCFPyL PET to improve detection of clinically significant primary prostate cancer in men with very low to intermediate risk prostate cancer under active surveillance or watchful waiting.
Update: As of July 2022 verification, the investigators are no longer enrolling into sub-studies 1 and 2.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single center, open label, single-arm, pilot study
| Arm | Type | Receives |
|---|---|---|
| 18F-DCFPyL PET | Experimental | Drug: 18F-DCFPyL PETFour separate substudies evaluating 18F-DCFPyL PET imaging of prostate cancer in four prostate cancer clinical scenarios under the following subheadings: (1) primary prostate cancer, (2) biochemical recurrence post-prostatectomy prior to radiation therapy, (3) androgen-resistant metastatic disease and (4) detection of clinically significant prostate cancer in low to intermediate risk primary prostate cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Prostate cancer pathologically proven by prostate biopsy (newly diagnosed for Sub-Study 1 and 4)
- Prostate biopsy histology grade ≥ Gleason 1, 6, 3+4, or 4+3; positive biopsy >2 cores
- Any PSA permitted
- Two consecutive rising PSA values (Sub-Study 3 only)
- Castrate-levels of testosterone - total testosterone < 50 ng/dL (Sub-Study 3 only)
Key exclusion criteria (10 listed)
- Prior pelvic external beam radiation therapy or brachytherapy
- Chemotherapy for prostate cancer
- Androgen deprivation therapy for prostate cancer
- Investigational therapy for prostate cancer (Sub-Study 3 Only)
- Unable to lie flat during or tolerate PET/CT
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-DCFPyL PET18F-DCFPyL PET demonstrates very high tumor-to-background and tumor specific uptake which may allow for a more sensitive and accurate method for detection of early tumor recurrence and metastatic disease as compared to current PET radiotracers and current standard-of-care imaging including 99mTc-methylene diphosphonate bone scintigraphy (bone scan), contrast-enhanced computed tomography (CT) and magnetic resonance imaging (MRI). | Drug | 18F-DCFPyL PET |
Primary outcome
18F-DCFPyL PSMA-based PET and multi-parametric MRI with DWI for Sub-Study 1: Primary Prostate Cancer
Time frame: one study visit (up to 3.5 hours)
To evaluate the performance of 18F-DCFPyL PSMA-based PET and multi-parametric MRI (MP-MRI) with DWI (Diffusion Weighted Imaging) and gadolinium DCE (Dynamic Contrast Enhanced) using a dedicated PET/MRI scanner to detect clinically significant larger volume high-grade primary prostate cancer based on prostatectomy step-section pathology correlation.
Evaluate 18F-DCFPyL PSMA-based PET for localization for Sub-Study 2: Biochemical Recurrence
Time frame: one study visit (up to 3.5 hours)
To evaluate the performance of 18F-DCFPyL PSMA-based PET for localization of the site of recurrent prostate cancer in men with biochemical recurrence after definitive prostatectomy with planned salvage external-beam radiation therapy (EBRT). PSA response to prostatic fossa salvage irradiation will be compared with pre-salvage 18F-DCFPyL PET uptake in the radiation field.
Compare detectability of 18F-DCFPyL for Sub-Study 3: Metastatic Androgen-Resistant Prostate Cancer
Time frame: up to 7 days
To compare the detectability of metastatic prostate cancer using 18F-DCFPyL PET obtained from PET/CT and PET/MRI compared to conventional imaging modalities (CIM) (bone scan and CT) in men with androgen-resistant prostate cancer.
Sub-Study 4: Rate of positive cancer detection using PET/MRI directed MRI/transrectal ultrasound (TRUS) fusion biopsy with and without additional PSMA PET information
Time frame: one study visit (up to 3.5 hours)
To evaluate the ability of 18F-DCFPyL PSMA PET to improve detection of clinically significant cancer in men with very low to intermediate risk prostate cancer using a dedicated PET/MRI.
15 secondary outcomes
Sub-study 1: Detection of local-nodal and distant metastatic disease (PET
Time frame: one study visit (up to 3.5 hours)
Sub-Study 1: Correlation of 18F-DCFPyL PET and MRI
Time frame: one study visit (up to 3.5 hours)
Sub-Study 1: Specificity of 18F-DCFPyL
Time frame: one study visit (up to 3.5 hours)
Sub-Study 1: Low-dose CT versus MRI derived PET SUV
Time frame: one study visit (up to 3.5 hours)
Sub-Study 2: Detection of local-nodal and distant metastatic disease (pelvic)
Time frame: one study visit (up to 3.5 hours)
Sub-Study 2: Dedicated pelvic 18F-DCFPyL PET/MRI with dynamic PET acquisition and multi-parametric MRI
Time frame: one study visit (up to 3.5 hours)
Sub-Study 3: Contribution of whole body MRI DWI
Time frame: Up to 7 days
Sub-Study 3: Quantitative accuracy
Time frame: Up to 7 days
Sub-Study 3: Quantitative reproducibility
Time frame: Up to 7 days
Sub-study 4: Positive Detection Rate of Prostate Cancer via biopsy on PSMA PET versus mpMRI alone in very low to intermediate risk groups active surveillance and watchful waiting patients
Time frame: one study visit (up to 3.5 hours)
Sub-study 4: Detection rate of clinically significant prostate cancer in men with directed MRI/US biopsy
Time frame: one study visit (up to 3.5 hours)
Sub-study 4: Detection Rate of Prostate Cancer vs False Positive Findings via Biopsy
Time frame: one study visit (up to 3.5 hours)
Sub-study 4: Number of Participants who change treatment and surgical management plans after inclusion of PSMA-based PET directed biopsy
Time frame: one study visit (up to 3.5 hours)
Sub-study 4: Correlation of PET and MRI parameters for PET and/or MRI positive lesions to biopsy histopathology, cancer grade group, PSA and other clinical parameters
Time frame: one study visit (up to 3.5 hours)
Sub-study 4: Change in Gleason Score
Time frame: one study visit (up to 3.5 hours), post-prostatectomy (standard of care)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- University of Wisconsin Carbone Cancer CenterLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Steve Y Cho, MD principal investigator
University of Wisconsin, Madison
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-DCFPyL PET in people with Prostate Cancer and Prostate Neoplasm, run by University of Wisconsin, Madison 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 11 inclusion and 10 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: finished, as of the sponsor's last update on 12 Dec 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
18F-DCFPyL PSMA-based PET and multi-parametric MRI with DWI for Sub-Study 1: Primary Prostate Cancer (time frame: one study visit (up to 3.5 hours)). The study lists 4 primary outcomes in all. 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 12 Dec 2024.