Metastatic Prostate CarcinomaPhase 2NCT03707184

Fluciclovine F18 PET/CT Imaging in Assessing Hormone-Naive Men With Prostate Cancer That Has Spread to the Bone

A Phase 2 study testing Computed Tomography, Fluciclovine F18 and Positron Emission Tomography in people with Metastatic Prostate Carcinoma and Prostate Carcinoma Metastatic in the Bone, run by University of Utah 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

Search all trials

Trial summary

This trial studies how well fluciclovine 18F PET/CT imaging works in assessing hormone-naive men with prostate cancer that has spread to the bone. Fluciclovine 18F is a radioactive drug used to measure tumor growth. PET/CT uses x-rays to take pictures inside the body. Read more about this study

Who is it for?: Any age, men only
Conditions the study is for: Metastatic Prostate Carcinoma, Prostate Carcinoma Metastatic in the Bone, Stage IV Prostate Cancer
What is being tested?: Computed Tomography, Fluciclovine F18 and Positron Emission Tomography
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 siteUnited States
Study dates: 2 Oct 2018to 3 Feb 2022
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 Any age
Men only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Enrollment on IRB #102312 (A Phase 2 Study of Radium-223 and Radiotherapy in Hormone-Naive Men with Oligometastatic Prostate Cancer to Bone).
Patients must document their willingness to be followed for up to 24 months after recruitment by signing informed consent documenting their agreement to allow access to the data obtained on IRB #102312 and information and data entered into a research database.
All patients, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines.

Who cannot join

Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals. Patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator?s discretion.
Patients who require monitored anesthesia for PET scanning.
Patients who are too claustrophobic to undergo PET scanning.

Trial locations and contacts

1 site in 1 country.

United States1 site

Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112

Other trials in United States

About this study

Official title: [18F]Fluciclovine Companion Imaging Study to Radium-223 and Radiotherapy in Hormone-Naive Men With Oligometastatic Prostate Cancer to Bone (RROPE) Study

Read the detailed description

PRIMARY OBJECTIVES:

Abnormal fluciclovine F18 ([18F] fluciclovine) uptake on visual assessment will differ by the type of metastatic lesion present (blastic, lytic, marrow, mixed).

II. Maximum standardized uptake value (SUVmax) and mean standardized uptake value (SUVmean) on (18F) fluciclovine-positron emission tomography (PET)/computed tomography (CT) imaging will differ by the type of metastatic lesion present (blastic, lytic, marrow, mixed).

SECONDARY OBJECTIVES:

Determine if a 25% or greater reduction in average (ave) SUVmax or ave SUVmean on (18F) fluciclovine-PET/CT imaging after completion of all radiation therapy will be predictive of increased time to biochemical failure.

II. Determine the correlation between the number of lesions, their visual uptake, and semi-quantitative uptake on technetium tc-99m medronate (99mTc-MDP) bone scintigraphy and (18F) fluciclovine- PET/CT at baseline.

III. Determine the correlation between the number of lesions, their visual uptake, and semi-quantitative uptake on 99mTc-MDP bone scintigraphy and (18F) fluciclovine- PET/CT after 3 and 6 cycles of treatment.

OUTLINE: This is a companion imaging study to Institutional Review Board (IRB) #102312 (A Phase 2 Study of Radium-223 and Radiotherapy in Hormone-Naive Men with Oligometastatic Prostate Cancer to Bone).

Patients receive fluciclovine F18 intravenously (IV) over 30 seconds and undergo PET/CT scan over 60 minutes at baseline, 3 months and at approximately 6 months of radium-223 therapy.

After completion of diagnostic testing, patients are followed for 2 years.

Conditions: Metastatic Prostate Carcinoma, Prostate Carcinoma Metastatic in the Bone, Stage IV Prostate Cancer
Being tested: Computed Tomography, Fluciclovine F18, Positron Emission Tomography
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computerized Axial Tomography (CAT), computerized tomography
Undergo PET/CT scan
Fluciclovine F18Drug
Also called (18F)Fluciclovine, 18F-Fluciclovine, Fluciclovine (18F)
Given IV
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan
Undergo PET/CT scan

Study groups in NCT03707184
Study group	Role	What they receive
Diagnostic (fluciclovine F18, PET/CT)	Experimental	Patients receive fluciclovine F18 intravenously (IV) over 30 seconds and undergo PET/CT scan over 60 minutes at baseline, 3 months and at approximately 6 months of radium-223 therapy. Receives: Procedure: Computed Tomography; Drug: Fluciclovine F18; Procedure: Positron Emission Tomography

What is being measured

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

Mean Standardized Uptake Value (SUVmean) by Lesion Type
Mean SUV values are reported according to the type of bone lesion (osteoblastic dense, osteoblastic ground glass, osteoblastic mixed, and osteolytic).
Measured: Participants were assessed using [18F]Fluciclovine-PET/CT at baseline, prior to initiating radium-223 therapy
Maximum Standardized Uptake Value (SUVmax) by Lesion Type
Maximum SUV values are reported according to the type of bone lesion (osteoblastic dense, osteoblastic ground glass, osteoblastic mixed, and osteolytic).
Measured: Participants were assessed using [18F]Fluciclovine-PET/CT at baseline, prior to initiating radium-223 therapy

Timeline

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

2 Oct 20183 Feb 2022

First posted16 Oct 2018
Study start2 Oct 2018
Primary completion3 Feb 2022
Study completion3 Feb 2022

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 Metastatic Prostate CarcinomaStudies of the same condition, open and under way.
More trials run by University of UtahThe 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: Phase 2
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03707184
Sponsor's protocol ID: HCI113970
Other IDs: NCI-2018-02083
Status last verified: Nov 2024
First submitted: 9 Oct 2018
Last updated: 29 Nov 2024
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

Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
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
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer

All Metastatic Prostate Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: [18F]Fluciclovine Companion Imaging Study to Radium-223 and Radiotherapy in Hormone-Naive Men With Oligometastatic Prostate Cancer to Bone (RROPE) Study
ClinicalTrials.gov ID: NCT03707184
Acronym / sponsor ID: HCI113970
Conditions: Metastatic Prostate Carcinoma, Prostate Carcinoma Metastatic in the Bone, Stage IV Prostate Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: University of UtahUniversity, hospital or other
Study start: 2 Oct 2018 (actual)
Primary completion: 3 Feb 2022 (actual)
Study completion: 3 Feb 2022 (actual)
First posted: 16 Oct 2018 (actual)
Results: Posted 29 Nov 2024

Clinical summary

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

Detailed description

PRIMARY OBJECTIVES:

Abnormal fluciclovine F18 ([18F] fluciclovine) uptake on visual assessment will differ by the type of metastatic lesion present (blastic, lytic, marrow, mixed).

SECONDARY OBJECTIVES:

Determine if a 25% or greater reduction in average (ave) SUVmax or ave SUVmean on (18F) fluciclovine-PET/CT imaging after completion of all radiation therapy will be predictive of increased time to biochemical failure.

Patients receive fluciclovine F18 intravenously (IV) over 30 seconds and undergo PET/CT scan over 60 minutes at baseline, 3 months and at approximately 6 months of radium-223 therapy.

After completion of diagnostic testing, patients are followed for 2 years.

Study design

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

Arm	Type	Receives
Diagnostic (fluciclovine F18, PET/CT)	Experimental	Procedure: Computed Tomography, Drug: Fluciclovine F18, Procedure: Positron Emission TomographyPatients receive fluciclovine F18 intravenously (IV) over 30 seconds and undergo PET/CT scan over 60 minutes at baseline, 3 months and at approximately 6 months of radium-223 therapy.

Who may qualify

Sex: Male only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Enrollment on IRB #102312 (A Phase 2 Study of Radium-223 and Radiotherapy in Hormone-Naive Men with Oligometastatic Prostate Cancer to Bone).
Patients must document their willingness to be followed for up to 24 months after recruitment by signing informed consent documenting their agreement to allow access to the data obtained on IRB #102312 and information and data entered into a research database.
All patients, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines.

Key exclusion criteria (3 listed)

Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals. Patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator?s discretion.
Patients who require monitored anesthesia for PET scanning.
Patients who are too claustrophobic to undergo PET scanning.

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
Computed TomographyAlso: CAT, CAT Scan, Computerized Axial Tomography (CAT), computerized tomographyUndergo PET/CT scan	Procedure or surgery	Diagnostic (fluciclovine F18, PET/CT)
Fluciclovine F18Also: (18F)Fluciclovine, 18F-Fluciclovine, Fluciclovine (18F)Given IV	Drug	Diagnostic (fluciclovine F18, PET/CT)
Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography ScanUndergo PET/CT scan	Procedure or surgery	Diagnostic (fluciclovine F18, PET/CT)

Primary outcome

Mean Standardized Uptake Value (SUVmean) by Lesion Type
Time frame: Participants were assessed using [18F]Fluciclovine-PET/CT at baseline, prior to initiating radium-223 therapy
Mean SUV values are reported according to the type of bone lesion (osteoblastic dense, osteoblastic ground glass, osteoblastic mixed, and osteolytic).
Maximum Standardized Uptake Value (SUVmax) by Lesion Type
Time frame: Participants were assessed using [18F]Fluciclovine-PET/CT at baseline, prior to initiating radium-223 therapy
Maximum SUV values are reported according to the type of bone lesion (osteoblastic dense, osteoblastic ground glass, osteoblastic mixed, and osteolytic).

Results and safety

Results posted to the registry on 29 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Diagnostic (Fluciclovine F18, PET/CT)	17	15

Primary outcome: Mean Standardized Uptake Value (SUVmean) by Lesion Type

Time frame: Participants were assessed using [18F]Fluciclovine-PET/CT at baseline, prior to initiating radium-223 therapy. Mean (Standard Deviation). Unit: SUV by body weight (kg)

Measure	Diagnostic (Fluciclovine F18, PET/CT) n = 17
Osteoblastic Dense	1.91 (0.69)
Osteoblastic Ground Glass	2.36 (1.12)
Osteoblastic Mixed	2.63 (1.26)
Osteolytic	3.05 (0.43)

Population analysed: The \[18F\]Fluciclovine-PET/CT scans were evaluated for 17 enrolled participants. The 19 lesions seen on PET that had a definitive CT correlate were categorized by lesion type. The number of units analyzed for each row reflect the number of lesions in each category. Some participants had multiple lesions of different types.

Primary outcome: Maximum Standardized Uptake Value (SUVmax) by Lesion Type

Time frame: Participants were assessed using [18F]Fluciclovine-PET/CT at baseline, prior to initiating radium-223 therapy. Mean (Standard Deviation). Unit: SUV by body weight (kg)

Measure	Diagnostic (Fluciclovine F18, PET/CT) n = 17
Osteoblastic Dense	4.80 (1.53)
Osteoblastic Ground Glass	7.17 (3.75)
Osteoblastic Mixed	8.39 (5.61)
Osteolytic	10.02 (3.33)

Adverse events

Time frame: Adverse events were assessed for 24 hours following administration of [18F] Fluciclovine dose.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Diagnostic (Fluciclovine F18, PET/CT)	0 of 17 (0%)	0 of 17 (0%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Metastatic Prostate Carcinoma

Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
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
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer

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.

Jeffrey Yap, PhD principal investigator

Huntsman Cancer Institute

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

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 3 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 29 Nov 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?

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 29 Nov 2024). 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?

Mean Standardized Uptake Value (SUVmean) by Lesion Type (time frame: Participants were assessed using [18F]Fluciclovine-PET/CT at baseline, prior to initiating radium-223 therapy). 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 NCT03707184.

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 29 Nov 2024.