Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence

University of Michigan

Status and phase: Completed; Phase 2

Conditions: Prostate Adenocarcinoma; Prostate Cancer Recurrent; Prostate Cancer Metastatic; Prostate Cancer

Treatments: Drug: 68Ga-PSMA

Study type: Interventional

Funder types: Other

Identifiers

NCT03396874

HUM125841

Details and patient eligibility

About

This study evaluates the value of Gallium-68 labeled PSMA (68Ga-PSMA) for PET/CT imaging of prostate cancer recurrence. 68Ga-PSMA is a radioactive molecule, which binds to prostate cancer cells. Together with a PET/CT scanner, the distribution of 68Ga-PSMA can be determined in the body.

To test this new drug, participants will receive an intravenous injection of Ga-68-PSMA and then have a PET/CT scan. The scan results will be made available to study participants and treating physicians.

Full description

This study evaluates Gallium-68 labelled PSMA-11 (also called Gallium-68 labelled PSMA-HBED-CC, or Gallium-68 labelled PSMA N,N'-bis(2-hydroxybenzyl)ethylenediamine-N,N'-diacetic acid), abbreviated here as 68Ga-PSMA. This molecule (or radiotracer) binds to receptors that are often present on prostate cancer cells. Using 68Ga-PSMA together with a positron emission tomography (PET) scanner (with computed tomography, called PET/CT), it is therefore possible to find prostate cancer lesions in the body. The study will test whether 68Ga-PSMA will identify prostate cancer more precisely than normal imaging methods (for example CT, MRI, or bone scan). A more precise identification of the location of the disease is important. Knowing where the disease is located will help to decide on the best course of action to treat the disease.

Men who have elevated tumor markers of prostate cancer are eligible for this study. Participants undergo a 68Ga-PSMA PET/CT scan before further treatment. Based on clinical information, including any prior imaging and biopsy/surgery information and follow-up information, we will determine whether 68Ga-PSMA PET/CT imaging was more accurate than the standard imaging. The study team will collect this information for up to 1 year after the 68Ga-PSMA PET/CT scan.

The results of the 68Ga-PSMA PET/CT scan will be shared with the participating patients. Also, results will be entered into the participant's medical record and shared with the treating physicians.

Enrollment: 1,435 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histopathological proven prostate adenocarcinoma.

2. Rising prostate specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).

   1. Post radical prostatectomy (RP) - according to American Urological Association (AUA) recommendation criteria: PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and confirmatory persistent PSA greater than 0.2 ng/mL.
   2. Post-radiation therapy - according to ASTRO-Phoenix consensus definition: Nadir + greater than or equal to 2 ng/mL rise in PSA.

3. Karnofsky performance status of ≥ 50.

4. Age ≥ 18.

5. Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion criteria

1. Current investigational therapy for prostate cancer.
2. Unable to lie flat, still or tolerate a PET/CT scan.
3. Prior history of a malignancy within the last 2 years, except skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized, and except superficial bladder cancer.
4. Prisoner.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,435 participants in 1 patient group

Patient participants

Experimental group

Description:

PET/CT imaging

Treatment:

Drug: 68Ga-PSMA