Castration-Resistant Prostate CarcinomaPhase 2NCT03448458

Gallium Ga 68-DOTATATE PET/CT in Diagnosing Patients With Metastatic Castration Resistant Prostate Cancer

A Phase 2 study testing CT (Computed Tomography), Gallium Ga 68-DOTATATE and Positron Emission Tomography in people with Castration-Resistant Prostate Carcinoma and Metastatic Prostate Carcinoma, run by Emory University 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

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IV Prostate Cancer AJCC v7
What is being tested?: CT (Computed Tomography), Gallium Ga 68-DOTATATE 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: 22 Feb 2018to 6 Feb 2023
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

Patients with metastatic castration resistant prostate carcinoma with skeletal, visceral and/or nodal involvement
Ability to lie still for PET scanning
Patients must be able to provide written informed consent

Who cannot join

Patients less than 18 years of age
Patients without metastatic castration resistant prostate carcinoma with skeletal, visceral and/or nodal involvement
Inability to lie still for PET scanning
Patients unable to provide written informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site

Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322

Other trials in United States

About this study

Official title: Molecular Imaging With Ga-68 DOTATATE PET to Investigate Neuroendocrine Differentiation in Prostate Cancer Patients

This pilot clinical trial studies how well gallium Ga 68-DOTATATE positron emission tomography (PET)/computed tomography (CT) works in treating patients with castration resistant prostate cancer that has spread to other placed in the body. Gallium Ga 68-DOTATATE PET/CT may help doctors to identify those patients with early neuroendocrine transdifferentiation and who are at greater risk for poor outcomes.

Read the detailed description

PRIMARY OBJECTIVE:

Establish the feasibility of using gallium Ga 68-DOTATATE (68Ga-DOTATATE) PET as a predictive imaging biomarker for neuroendocrine transdifferentiation in prostate cancer.

SECONDARY OBJECTIVE:

Correlate progression of disease with degree of uptake on 68Ga-DOTATATE PET examination.

OUTLINE:

Patients receive gallium Ga 68-DOTATATE intravenously (IV). Within 55-70 minutes, patients undergo PET/CT.

After completion of study, patients are followed up for at least 1 year.

Conditions: Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IV Prostate Cancer AJCC v7
Being tested: CT (Computed Tomography), Gallium Ga 68-DOTATATE, 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.

CT (Computed Tomography)Procedure or surgery
Also called CAT, CAT Scan, Computerized Axial Tomography, computerized tomography
Undergo PET/CT
Gallium Ga 68-DOTATATEDrug
Also called 68Ga-DOTATATE, Gallium-68 DOTA-DPhe1, Tyr3-octreotate
Given IV
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET scan, proton magnetic resonance spectroscopic imaging
Undergo PET/CT

Study groups in NCT03448458
Study group	Role	What they receive
Gallium Ga 68-DOTATATE PET/CT	Experimental	Patients receive gallium Ga 68-DOTATATE IV. Within 55-70 minutes, patients undergo PET (positron emission tomography)/CT (computed tomography). Receives: Procedure: CT (Computed Tomography); Drug: Gallium Ga 68-DOTATATE; Procedure: Positron Emission Tomography

What is being measured

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

Gallium Ga 68-DOTATATE Uptake
The number of participants with uptake in each type of lesion will be reported. Will be summarized using descriptive statistics. The inter-rater agreement will be assessed by Kappa statistics or intra-class correlation coefficient. The degree of uptake will be plotted against length of time to progress, and the association will be described by Spearman correlation coefficient with 95% confidence interval (CI). In addition, will dichotomize degree of update by median and defined it as high vs. low, and apply Wilcoxon rank sum test or Fisher exact test wherever appropriate.
Measured: During PET/CT scan, up to 2 hours

Secondary outcomes (1)

Progression Free Survival
Will be associated with 68Ga-DOTATATE uptake. Will be described by Kaplan-Meier method along log-rank p-value.
Measured: Date of enrollment to date of progression (radiographic progression or clinical deterioration) or death, or last follow up if event free, assessed up to 36 months

Timeline

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

22 Feb 20186 Feb 2023

First posted28 Feb 2018
Study start22 Feb 2018
Primary completion6 Feb 2023
Study completion6 Feb 2023

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 Castration-Resistant Prostate CarcinomaStudies of the same condition, open and under way.
More trials run by Emory UniversityThe 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: NCT03448458
Sponsor's protocol ID: IRB00099167
Other IDs: NCI-2017-02055, Winship4165-17
Status last verified: Jul 2025
First submitted: 22 Feb 2018
Last updated: 17 Jul 2025
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 Castration-Resistant Prostate Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Molecular Imaging With Ga-68 DOTATATE PET to Investigate Neuroendocrine Differentiation in Prostate Cancer Patients
ClinicalTrials.gov ID: NCT03448458
Acronym / sponsor ID: IRB00099167
Conditions: Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IV Prostate Cancer AJCC v7
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: Emory UniversityUniversity, hospital or other
Study start: 22 Feb 2018 (actual)
Primary completion: 6 Feb 2023 (actual)
Study completion: 6 Feb 2023 (actual)
First posted: 28 Feb 2018 (actual)
Results: Posted 17 Jul 2025

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 OBJECTIVE:

Establish the feasibility of using gallium Ga 68-DOTATATE (68Ga-DOTATATE) PET as a predictive imaging biomarker for neuroendocrine transdifferentiation in prostate cancer.

SECONDARY OBJECTIVE:

Correlate progression of disease with degree of uptake on 68Ga-DOTATATE PET examination.

OUTLINE:

Patients receive gallium Ga 68-DOTATATE intravenously (IV). Within 55-70 minutes, patients undergo PET/CT.

After completion of study, patients are followed up for at least 1 year.

Study design

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

Arm	Type	Receives
Gallium Ga 68-DOTATATE PET/CT	Experimental	Procedure: CT (Computed Tomography), Drug: Gallium Ga 68-DOTATATE, Procedure: Positron Emission TomographyPatients receive gallium Ga 68-DOTATATE IV. Within 55-70 minutes, patients undergo PET (positron emission tomography)/CT (computed tomography).

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients with metastatic castration resistant prostate carcinoma with skeletal, visceral and/or nodal involvement
Ability to lie still for PET scanning
Patients must be able to provide written informed consent

Key exclusion criteria (4 listed)

Patients less than 18 years of age
Patients without metastatic castration resistant prostate carcinoma with skeletal, visceral and/or nodal involvement
Inability to lie still for PET scanning
Patients unable to provide written informed consent

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
CT (Computed Tomography)Also: CAT, CAT Scan, Computerized Axial Tomography, computerized tomographyUndergo PET/CT	Procedure or surgery	Gallium Ga 68-DOTATATE PET/CT
Gallium Ga 68-DOTATATEAlso: 68Ga-DOTATATE, Gallium-68 DOTA-DPhe1, Tyr3-octreotateGiven IV	Drug	Gallium Ga 68-DOTATATE PET/CT
Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET scan, proton magnetic resonance spectroscopic imagingUndergo PET/CT	Procedure or surgery	Gallium Ga 68-DOTATATE PET/CT

Primary outcome

Gallium Ga 68-DOTATATE Uptake
Time frame: During PET/CT scan, up to 2 hours
The number of participants with uptake in each type of lesion will be reported. Will be summarized using descriptive statistics. The inter-rater agreement will be assessed by Kappa statistics or intra-class correlation coefficient. The degree of uptake will be plotted against length of time to progress, and the association will be described by Spearman correlation coefficient with 95% confidence interval (CI). In addition, will dichotomize degree of update by median and defined it as high vs. low, and apply Wilcoxon rank sum test or Fisher exact test wherever appropriate.

1 secondary outcome

Progression Free Survival
Time frame: Date of enrollment to date of progression (radiographic progression or clinical deterioration) or death, or last follow up if event free, assessed up to 36 months

Results and safety

Results posted to the registry on 17 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Gallium Ga 68-DOTATATE PET/CT	17	16

Primary outcome: Gallium Ga 68-DOTATATE Uptake

Time frame: During PET/CT scan, up to 2 hours. Count of participants. Unit: Participants

Measure	Gallium Ga 68-DOTATATE PET/CT n = 16
Bone and visceral/nodal lesions	11
Only bone lesions	4
Only nodal disease	1

Population analysed: One patient was subsequently found to have an additional metastatic pulmonary squamous cell carcinoma and was excluded from this analysis.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 3 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Gallium Ga 68-DOTATATE PET/CT	0 of 17 (0%)	0 of 17 (0%)	2 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Castration-Resistant 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.

Mehmet Asim Bilen, MD principal investigator

Emory University

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 4 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 17 Jul 2025. 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 17 Jul 2025). 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?

Gallium Ga 68-DOTATATE Uptake (time frame: During PET/CT scan, up to 2 hours). 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 NCT03448458.

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 17 Jul 2025.