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

Andrei Iagaru

Status and phase: Completed; Phase 3; Phase 2

Conditions: Prostate Adenocarcinoma; Recurrent Prostate Carcinoma; PSA Failure

Treatments: Procedure: Positron Emission Tomography (PET); Procedure: Computed Tomography (CT) scan; Drug: 68Ga-PSMA-11

Study type: Interventional

Funder types: Other

Identifiers

NCT02673151

NCI-2016-00094 (Registry Identifier)

PROS0076 (Other Identifier)

IRB-35932

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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61 participants in 1 patient group

68Ga-PSMA-11 PET/CT

Experimental group

Description:

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 .

Treatment:

Drug: 68Ga-PSMA-11

Procedure: Computed Tomography (CT) scan

Procedure: Positron Emission Tomography (PET)