68Ga-PSMA PET/CT in Detecting Prostate Cancer Recurrence in Patients With Elevated PSA After Initial Treatment

NCT ID: NCT02673151

Last Updated: 2022-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-20
• Study Completion Date: 2019-04-27

Brief Summary

The purpose of this research study is to see if recurrent prostate cancer can be identified using a special procedure called a positron emission tomography (PET) scan. PET/CT is used to describe information regarding the function, as well as location and size of a tumor.

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate 68Ga-PSMA-11 PET/CT for detection of recurrent prostate cancer after initial therapy in patients with elevated PSA. PSMA refers to prostate-specific membrane antigen.

Eligible participants will undergo baseline assessments at enrollment. Study participants will receive 68Ga-PSMA-11 and undergo a PET/CT. Participants will be contacted at 24 to 72 hours following the scan in order to capture potential late occurring adverse events. Clinical follow up of participant at 3 to 12 months following the scan in order to analyze secondary endpoints.

Conditions

Prostate Adenocarcinoma; PSA Failure; Recurrent Prostate Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

68Ga-PSMA-11 PET/CT

Patients receive 68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11). Participant will be injected IV with 3 to 7 millicurie (mCi) of 68Ga-PSMA-11. Beginning 50 to 100 minutes later, a low-dose computed tomography (CT) scan will be obtained from vertex to mid thighs; followed by a static positron emission tomography (PET) scan over the same .

Group Type: EXPERIMENTAL

Computed Tomography (CT) scan

Intervention Type: PROCEDURE

PET/CT scan using 68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11).

68Ga-PSMA-11

Intervention Type: DRUG

68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11), administered by intravenous (IV) injection.

Positron Emission Tomography (PET)

Intervention Type: PROCEDURE

PET/CT scan using 68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11).

Interventions

Computed Tomography (CT) scan

PET/CT scan using 68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11).

Intervention Type: PROCEDURE

68Ga-PSMA-11

68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11), administered by intravenous (IV) injection.

Intervention Type: DRUG

Positron Emission Tomography (PET)

PET/CT scan using 68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11).

Intervention Type: PROCEDURE

Other Intervention Names

Computerized Axial Tomography (CAT); CAT scan; Computed Tomography (CT); Computerized Tomography (CT); CT Scan; tomography; 68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11); 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC; 68Ga-HBED-CC-PSMA; HBED-CC-PSMA; DFKZ-11; Heidelberg compound; Positron Emission Tomography scan (PET-scan); Proton magnetic resonance spectroscopic imaging

Eligibility Criteria

Inclusion Criteria

• Histopathological proven prostate adenocarcinoma
• Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy)

• Post radical prostatectomy (RP) - American Urology Association (AUA) recommendation

• PSA greater than 0.2 ng/mL measured 6 to 13 weeks after RP
• Confirmatory persistent PSA greater than 0.2 ng/mL (total of two PSA measurements greater than 0.2 ng/mL)
• Post-radiation therapy -American Society for Radiation Oncology (ASTRO)-Phoenix consensus definition

• A rise of PSA measurement of 2 or more ng/mL over the nadir
• Karnofsky performance status of ≥ 50 (or Eastern Cooperative Oncology Group [ECOG] / World Health Organization [WHO] equivalent)
• Able to provide written consent

Exclusion Criteria

• Investigational therapy for prostate cancer.
• Unable to lie flat, still or tolerate a positron emission tomograpy (PET) scan.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Andrei Iagaru

OTHER

Sponsor Role: lead

Responsible Party

Andrei Iagaru

Professor of Radiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Andrei Iagaru, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University, School of Medicine

Palo Alto, California, United States

Countries

United States

References

Baratto L, Song H, Duan H, Hatami N, Bagshaw HP, Buyyounouski M, Hancock S, Shah S, Srinivas S, Swift P, Moradi F, Davidzon G, Iagaru A. PSMA- and GRPR-Targeted PET: Results from 50 Patients with Biochemically Recurrent Prostate Cancer. J Nucl Med. 2021 Nov;62(11):1545-1549. doi: 10.2967/jnumed.120.259630. Epub 2021 Mar 5.

Reference Type: DERIVED

PMID: 33674398 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NCI-2016-00094

Identifier Type: REGISTRY

Identifier Source: secondary_id

PROS0076

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-35932

Identifier Type: -

Identifier Source: org_study_id