Clinical trial NCT04614363: 68 Ga-PSMA for High Risk Prostate Cancer
Official title: Comparison of 68 Ga-PSMA Positron Emission Tomography (PET)/CT to Conventional Imaging in Men With High Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
High Risk
Keywords: PSMA
68 Ga
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 80
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects will receive the Investigational Product.
Primary purpose: DIAGNOSTIC

Brief summary: This is a prospective, single-center, open-label pilot study of 68GA-PSMA-11 given at a single time prior to PET/CT imaging in men with localized high risk prostate cancer or biochemical recurrence. The imaging agent (68 Ga-PSMA 11 will be administered on an outpatient basis. It will be administered prior to the PET/CT imaging. The objective is to evaluate the distribution of 68GA-PSMA-11 in tissues and to determine if this alters the planned clinical management.

Detailed description: This is a prospective, open label, single-center, single-arm, pilot diagnostic accuracy study to evaluate the tissue distribution of 68Ga-PSMA Positron Emission Tomography (PET)/CT in 80 patients with high risk localized prostate cancer or biochemical recurrence.

Subjects will receive a single IV dose of 3-7 mCi of 68Ga-PSMA (study drug) followed by PET/CT imaging 60-90 minutes after injection. All patients will be closely monitored with vital signs (blood pressure and heart rate), before and 2 hours following radiotracer administration.

Patients will receive a phone call 2 days following PET/CT to assess for adverse events.

To minimize bias, all PET/CT images will be interpreted by a board-certified radiologist. The radiologist evaluating the images will be blinded to the final outcome, such as the histopathology of any biopsies and the outcome of subsequent imaging.

Patients with study-defined high-risk features who are eligible and scheduled for radical prostatectomy will undergo 68Ga-PSMA-11 PET/CT injection. The results of the 68Ga-PSMA-11 PET/CT may alter patient management in one of several ways, including the decision to not pursue surgical extirpation (e.g. in the event of extensive distant metastasis) in favor of systemic therapy. It is also possible that the extent of surgical resection may be altered, such as non-regional pelvic or retroperitoneal lymph node dissection. The alteration in planned surgical treatment from standard of care will be recorded as a secondary-end point.

Eligibility criteria: Inclusion Criteria:

* Male aged 21 years or older
* Ability to understand and provide written informed consent
* All patients must have histopathological proven adenocarcinoma of the prostate
* ECOG performance status 0-1
* No evidence of other malignancy (except squamous or basal cell skin cancers)
* Consent to use acceptable form of birth control following the imaging period (condoms for a period of seven days after injection if sexually active)

A. Inclusion criteria specific for the pre-prostatectomy group:

Untreated prostate Cancer with high-risk features, as defined as having at least one of the following criteria:

i. PSA ≥ 20.0 ng/mL ii. ISUP Gleason Grade Group 3, 4 or 5 iii. Clinical stage T3

B. Inclusion criteria specific for biochemical recurrence:

(i) Histopathological proven prostate adenocarcinoma (ii)Rising PSA after definitive therapy with prostatectomy or radiation (therapy (external beam or brachytherapy).

1. Post radical prostatectomy (RP), PSA greater than or equal to 0.2 ng/ml measured more than 6 weeks after RP.
2. Post-radiation therapy, PSA that is equal to or greater than 2 ng/ml rise above PSA nadir

Exclusion Criteria:

* Unable to tolerate a PET/CT (e.g. unable to lie flat)
* Recent history of a secondary malignancy in the past year, excluding non-melanoma skin cancer (non-metastatic)
* Known allergic reactions to 68-Ga, or gadolinium-based contrast agents.
* Treatment with another investigational drug or other intervention 2 years.
* Patient has any medical, psychological or social condition that, in opinion of the investigator will make difficult for the participant to tolerate study intervention.

Primary outcomes:
measure: Proportion of Patients With Lymph Node Involvement
timeFrame: 18 months
measure: Proportion of Patients Which Clinical Management Was Altered
timeFrame: 18 months
Secondary outcomes:
measure: Intensity of Uptake as a Predictor of Clinical Outcome or Aggressiveness
timeFrame: 18 months
measure: Number of Patients With Suspicious Lesions
timeFrame: 18 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Brian Miles, MD
role: PRINCIPAL_INVESTIGATOR
References: