Prostate CancerPhase 2NCT03263780

High Resolution PET-MRI Before Prostate Cancer HIFU

A Phase 2 study testing 18F-Fluciclovine in people with Prostate Cancer, run by Timothy J. Daskivich at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This prospective trial aims to determine if enhanced prostate imaging using two novel imaging technologies (high resolution DWI and 18F-fluciclovine PET-MRI) will detect prostate cancers not seen on standard multiparametric prostate MRI in patients considered candidates for focal HIFU. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostate Cancer
What is being tested?: 18F-Fluciclovine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteUnited States
Study dates: 7 Dec 2017to 8 Jan 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 biopsy consisting of ≥ 10 tissue cores sampled
PSA </=20 ng/mL
cT1-cT2c
Either overall gleason score >/= 7 with Gleason grade 4 or 5 component localized to one lobe (i.e. right or left) OR overall Gleason score 6 with >/= half of systematic biopsy cores positive and >/= 50% of core involvement in at least one core
Patient considering focal HIFU therapy

Who cannot join

Previous local therapy for prostate cancer
Inability to receive PET tracer
Inability to receive MRI
Suggestion of extracapsular extension or seminal vesicle invasion on imaging
Estimated creatinine clearance <45 mL/min (Cockcroft-Gault equation)
Any other condition which, in the investigator's option, may make the patient a poor candidate for participation in a clinical trial.

Trial locations and contacts

1 site in 1 country.

United States1 site

Cedars-Sinai Medical Center
Los Angeles, California, 90048

Other trials in United States

About this study

Official title: High-Resolution, 18F-fluciclovine PET-MRI for Mapping Prostate Cancer in Patients Considering Focal High-Intensity Focused Ultrasound (HIFU) Therapy

Read the detailed description

This is a prospective trial to evaluate the effectiveness of 18F-fluciclovine PET-hrMRI versus standard mpMRI at identifying prostate cancer targets for HIFU therapy.

Participants with clinically localized, unilateral high grade prostate cancer (Gleason score 7-10 prostate cancer localized to one lobe on prior biopsies) OR at high risk for having unrecognized high grade prostate cancer (overall Gleason score 6 with > half of systematic biopsy cores positive and > 50% of core involvement in at least one core), interested in HIFU would receive both a standard mpMRI and 18F-fluciclovine PET-hrMRI.

Participants would then undergo a mapping biopsy using a standard sextant template plus MRI/US-fusion targeted biopsy of any lesion suspicious lesion on mpMRI or PET-hrMRI.

Conditions: Prostate Cancer
Being tested: 18F-Fluciclovine
Keywords: Diagnostic imaging, High-Intensity Focused Ultrasound, HIFU, 18F-Fluciclovine, high resolution diffusion-weighted imaging
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-FluciclovineDrug
Also called Axumin, prostate-cancer-specific radiotracer
Imaging (comparing standard and experimental high resolution diffusion-weighted imaging [DWI] MRI with 18F-Fluciclovine)

Study groups in NCT03263780
Study group	Role	What they receive
18F-Fluciclovine	Experimental	10mCi +/-20% 18F-fluciclovine injection Receives: Drug: 18F-Fluciclovine

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Biopsy-proven Cancers (Gleason 6+) That Standard Imaging (mpMRI) Would Have Missed Compared With High Resolution Diffusion-weighted Imaging (DWI) PET-hrMRI on Mapping MRI.
A Gleason score of 6 is low grade, 7 is intermediate grade, and a score of 8 to 10 is high grade cancer. The Prostate Imaging Reporting and Data System (PI-RADS) is used to report how likely it is that a suspicious area is a clinically significant cancer. PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious). Difference between sensitivities to identify prostate lesions. This is analyzed by the number of biopsy-proven cancerous zones (Gleason 6+) that mpMRI missed compared to PET or hrMRI (PIRADS) compared as follows:
mpMRI vs hrMRI and PET (PIRADS 3-5 \& Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 3-5 \& Gleason 7+)
mpMRI vs hrMRI and PET (PIRADS 4-5 \& Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 4-5 \& Gleason 7+)
mpMRI vs hrMRI and PET (PIRADS 3-5 \& Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 3-5 \& Gleason 6+)
mpMRI vs hrMRI and PET (PIRADS 4-5 \& Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 4-5 \& Gleason 6+)
Measured: At time of post-imaging biopsy
Number of Biopsy-proven Cancers (Gleason 7+) That Standard Imaging (mpMRI) Would Have Missed Compared With High Resolution Diffusion-weighted Imaging (DWI) PET-hrMRI on Mapping MRI.
A Gleason score of 6 is low grade, 7 is intermediate grade, and a score of 8 to 10 is high grade cancer. The Prostate Imaging Reporting and Data System (PI-RADS) is used to report how likely it is that a suspicious area is a clinically significant cancer. PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious). Difference between sensitivities to identify prostate lesions. This is analyzed by the number of biopsy-proven cancerous zones (Gleason 7+) that mpMRI missed compared to PET or hrMRI (PIRADS) compared as follows:
mpMRI vs hrMRI and PET (PIRADS 3-5 \& Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 3-5 \& Gleason 7+)
mpMRI vs hrMRI and PET (PIRADS 4-5 \& Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 4-5 \& Gleason 7+)
mpMRI vs hrMRI and PET (PIRADS 3-5 \& Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 3-5 \& Gleason 6+)
mpMRI vs hrMRI and PET (PIRADS 4-5 \& Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 4-5 \& Gleason 6+)
Measured: At time of post-imaging biopsy

Secondary outcomes (2)

Negative Biopsy Rate (Number of Participants With Negative Biopsy)
A Gleason score of 6 is low grade, 7 is intermediate grade, and a score of 8 to 10 is high grade cancer. The Prostate Imaging Reporting and Data System (PI-RADS) is used to report how likely it is that a suspicious area is a clinically significant cancer. PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious). Following the tumor mapping study, patients with high grade disease (i.e. Gleason grade 4 or 5) in one lobe undergo hemigland or focal HIFU of that lobe. Patients would then undergo repeat prostate biopsy to assess the negative biopsy rate in the treated region.
Measured: 6 months following standard HIFU therapy
Rate of High Grade Cancer (Number of Patients With High Grade Cancer)
A Gleason score of 6 is low grade, 7 is intermediate grade, and a score of 8 to 10 is high grade cancer. The Prostate Imaging Reporting and Data System (PI-RADS) is used to report how likely it is that a suspicious area is a clinically significant cancer. PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious). Following the tumor mapping study, patients with high grade disease (i.e. Gleason grade 4 or 5) in one lobe undergo hemigland or focal HIFU of that lobe. Patients would then undergo repeat prostate biopsy to assess the absence of Gleason grade 4 or 5 in the untreated region.
Measured: 6 months following standard HIFU therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Dec 20178 Jan 2020

First posted28 Aug 2017
Study start7 Dec 2017
Primary completion8 Jan 2020
Study completion8 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Phase 2
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03263780
Sponsor's protocol ID: IIT2016-19-DASKIVICH-18F
Status last verified: Feb 2021
First submitted: 22 Aug 2017
Last updated: 21 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Not yet recruitingPhase 3
A Study of JNJ-101556143 With Best Supportive Care in Participants With Metastatic Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
Metastatic Prostate Cancer
RecruitingPhase 2
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
Prostate Adenocarcinoma

All Prostate Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: High-Resolution, 18F-fluciclovine PET-MRI for Mapping Prostate Cancer in Patients Considering Focal High-Intensity Focused Ultrasound (HIFU) Therapy
ClinicalTrials.gov ID: NCT03263780
Acronym / sponsor ID: IIT2016-19-DASKIVICH-18F
Conditions: Prostate Cancer
Keywords: Diagnostic imaging, High-Intensity Focused Ultrasound, HIFU, 18F-Fluciclovine, high resolution diffusion-weighted imaging
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Timothy J. DaskivichUniversity, hospital or other
Collaborators: Blue Earth Diagnostics
Study start: 7 Dec 2017 (actual)
Primary completion: 8 Jan 2020 (actual)
Study completion: 8 Jan 2020 (actual)
First posted: 28 Aug 2017 (actual)
Results: Posted 21 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This is a prospective trial to evaluate the effectiveness of 18F-fluciclovine PET-hrMRI versus standard mpMRI at identifying prostate cancer targets for HIFU therapy.

Participants would then undergo a mapping biopsy using a standard sextant template plus MRI/US-fusion targeted biopsy of any lesion suspicious lesion on mpMRI or PET-hrMRI.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
18F-Fluciclovine	Experimental	Drug: 18F-Fluciclovine10mCi +/-20% 18F-fluciclovine injection

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)

Prostate biopsy consisting of ≥ 10 tissue cores sampled
PSA </=20 ng/mL
cT1-cT2c
Either overall gleason score >/= 7 with Gleason grade 4 or 5 component localized to one lobe (i.e. right or left) OR overall Gleason score 6 with >/= half of systematic biopsy cores positive and >/= 50% of core involvement in at least one core
Patient considering focal HIFU therapy

Key exclusion criteria (6 listed)

Previous local therapy for prostate cancer
Inability to receive PET tracer
Inability to receive MRI
Suggestion of extracapsular extension or seminal vesicle invasion on imaging
Estimated creatinine clearance <45 mL/min (Cockcroft-Gault equation)

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-FluciclovineAlso: Axumin, prostate-cancer-specific radiotracerImaging (comparing standard and experimental high resolution diffusion-weighted imaging [DWI] MRI with 18F-Fluciclovine)	Drug	18F-Fluciclovine

Primary outcome

Number of Biopsy-proven Cancers (Gleason 6+) That Standard Imaging (mpMRI) Would Have Missed Compared With High Resolution Diffusion-weighted Imaging (DWI) PET-hrMRI on Mapping MRI.
Time frame: At time of post-imaging biopsy
A Gleason score of 6 is low grade, 7 is intermediate grade, and a score of 8 to 10 is high grade cancer. The Prostate Imaging Reporting and Data System (PI-RADS) is used to report how likely it is that a suspicious area is a clinically significant cancer. PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious). Difference between sensitivities to identify prostate lesions. This is analyzed by the number of biopsy-proven cancerous zones (Gleason 6+) that mpMRI missed compared to PET or hrMRI (PIRADS) compared as follows: mpMRI vs hrMRI and PET (PIRADS 3-5 \& Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 3-5 \& Gleason 7+) mpMRI vs hrMRI and PET (PIRADS 4-5 \& Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 4-5 \& Gleason 7+) mpMRI vs hrMRI and PET (PIRADS 3-5 \& Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 3-5 \& Gleason 6+) mpMRI vs hrMRI and PET (PIRADS 4-5 \& Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 4-5 \& Gleason 6+)
Number of Biopsy-proven Cancers (Gleason 7+) That Standard Imaging (mpMRI) Would Have Missed Compared With High Resolution Diffusion-weighted Imaging (DWI) PET-hrMRI on Mapping MRI.
Time frame: At time of post-imaging biopsy
A Gleason score of 6 is low grade, 7 is intermediate grade, and a score of 8 to 10 is high grade cancer. The Prostate Imaging Reporting and Data System (PI-RADS) is used to report how likely it is that a suspicious area is a clinically significant cancer. PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious). Difference between sensitivities to identify prostate lesions. This is analyzed by the number of biopsy-proven cancerous zones (Gleason 7+) that mpMRI missed compared to PET or hrMRI (PIRADS) compared as follows: mpMRI vs hrMRI and PET (PIRADS 3-5 \& Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 3-5 \& Gleason 7+) mpMRI vs hrMRI and PET (PIRADS 4-5 \& Gleason 7+) mpMRI vs hrMRI or PET (PIRADS 4-5 \& Gleason 7+) mpMRI vs hrMRI and PET (PIRADS 3-5 \& Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 3-5 \& Gleason 6+) mpMRI vs hrMRI and PET (PIRADS 4-5 \& Gleason 6+) mpMRI vs hrMRI or PET (PIRADS 4-5 \& Gleason 6+)

2 secondary outcomes

Negative Biopsy Rate (Number of Participants With Negative Biopsy)
Time frame: 6 months following standard HIFU therapy
Rate of High Grade Cancer (Number of Patients With High Grade Cancer)
Time frame: 6 months following standard HIFU therapy

Results and safety

Results posted to the registry on 21 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
18F-Fluciclovine	21	11

Primary outcome: Number of Biopsy-proven Cancers (Gleason 6+) That Standard Imaging (mpMRI) Would Have Missed Compared With High Resolution Diffusion-weighted Imaging (DWI) PET-hrMRI on Mapping MRI.

Time frame: At time of post-imaging biopsy. Number. Unit: Total biopsy-proven cancers (Gleason 6+)

Measure	18F-Fluciclovine n = 13
Number of biopsy-proven cancers (Gleason 6+) that mpMRI missed compared to PET or hrMRI (PIRADS 3-5)	5
Number of biopsy-proven cancers (Gleason 6+) that mpMRI missed compared to PET & hrMRI (PIRADS 3-5)	1
Number of biopsy-proven cancers (Gleason 6+) that mpMRI missed compared to PET or hrMRI (PIRADS 4-5)	4
Number of biopsy-proven cancers (Gleason 6+) that mpMRI missed compared to PET & hrMRI (PIRADS 4-5)	1

18F-Fluciclovine: Sensitivity: 0.25 (95% CI 0.19 to 0.46), p = 0.056, Durkalski's Chi-square test
18F-Fluciclovine: Sensitivity: 0.56 (95% CI 0.44 to 0.78), p = 0.56, Durkalski's Chi-square test
18F-Fluciclovine: Sensitivity: 0.22 (95% CI 0.17 to 0.47), p = 0.060, Durkalski's Chi-square test

Primary outcome: Number of Biopsy-proven Cancers (Gleason 7+) That Standard Imaging (mpMRI) Would Have Missed Compared With High Resolution Diffusion-weighted Imaging (DWI) PET-hrMRI on Mapping MRI.

Time frame: At time of post-imaging biopsy. Number. Unit: Total biopsy-proven cancers (Gleason 7+)

Measure	18F-Fluciclovine n = 13
Number of biopsy-proven cancers (Gleason 7+) that mpMRI missed compared to PET or hrMRI (PIRADS 3-5)	1
Number of biopsy-proven cancers (Gleason 7+) that mpMRI missed compared to PET & hrMRI (PIRADS 3-5)	1
Number of biopsy-proven cancers (Gleason 7+) that mpMRI missed compared to PET or hrMRI (PIRADS 4-5)	1
Number of biopsy-proven cancers (Gleason 7+) that mpMRI missed compared to PET & hrMRI (PIRADS 4-5)	1

18F-Fluciclovine: Sensitivity: 0.35 (95% CI 0.26 to 0.65), p = 0.096, Durkalski's Chi-square test
18F-Fluciclovine: Sensitivity: 0.60 (95% CI 0.46 to 0.90), p = 0.317, Durkalski's Chi-square test
18F-Fluciclovine: Sensitivity: 0.30 (95% CI 0.23 to 0.66), p = 0.063, Durkalski's Chi-square test

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 6 months following standard HIFU therapy.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
18F-Fluciclovine	1 of 13 (7.7%)	0 of 13 (0%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Prostate Cancer

RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Not yet recruitingPhase 3
A Study of JNJ-101556143 With Best Supportive Care in Participants With Metastatic Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
Metastatic Prostate Cancer
RecruitingPhase 2
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
Prostate Adenocarcinoma

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.

Timothy Daskivich, MD principal investigator

Cedars-Sinai Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 18F-Fluciclovine in people with Prostate Cancer, run by Timothy J. Daskivich 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 6 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 21 Feb 2021. 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?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Biopsy-proven Cancers (Gleason 6+) That Standard Imaging (mpMRI) Would Have Missed Compared With High Resolution Diffusion-weighted Imaging (DWI) PET-hrMRI on Mapping MRI. (time frame: At time of post-imaging biopsy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03263780.

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 21 Feb 2021.