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  5. Drug Trials Snapshot: Ga 68 PSMA-11
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Drug Trials Snapshot: Ga 68 PSMA-11

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to the Ga 68 PSMA-11 Prescribing Information for complete information.

Ga 68 PSMA-11
UCLA Nuclear Medicine, UCSF Nuclear Medicine
Approval date: December 1, 2010


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

Ga 68 PSMA-11 is a drug used for detection of specific cancer lesions in men with prostate cancer

  • whose newly diagnosed cancer could be cured with the initial treatment, or
  • who have been treated for prostate cancer but have high prostate-specific antigen (PSA) in their blood. High PSA in the blood of these patients is a suspicious sign that cancer is coming back or spreading.

How is this drug used?

Ga 68 PSMA-11 is an injection given by a health care provider in the vein (intravenous) in preparation for an imaging test that can help detect cancer (called positron emission tomography or PET scan imaging).

What are the benefits of this drug?

PET imaging done after Ga 68 PSMA-11 injection showed sites of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

  • Sex: All trial participants were men; therefore, sex differences cannot be determined.
  • Race: Majority of participants in the clinical trials were White. Differences among races could not be determined because of the small number of participants from other races.
  • Age: Ga 68 PSMA-11 worked similarly in patients younger and older than 65 years of age.

What are the possible side effects?

Ga 68 PSMA-11 is a radioactive drug which will increase lifetime radiation exposure.

The most common side effects of Ga 68 PSMA-11 are nausea, diarrhea and dizziness.

Were there any differences in side effects among sex, race and age?

  • Sex: All trial participants were men, therefore sex differences in side effects could not be determined.
  • Race: Majority of participants in the clinical trials were White. Differences in side effects among races could not be determined due to small number of participants from other races.
  • Age: The occurrence of side effects between patients younger and older than 65 years of age was similar.

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the trials?

The FDA approved Ga 68 PSMA-11 based on evidence from two clinical trials (Trial 1/NCT0336847 identical to NCT02919111 and Trial 2/NCT02940262 identical to NCT02918357) of male patients with prostate cancer. Some patients were recently diagnosed with the prostate cancer. Other patients were treated before, but there was suspicion that the cancer was spreading because of rising prostate specific antigen or PSA. The trials were conducted at 2 sites in the USA.

The figure below summarizes how many male participants were in the clinical trials.

Figure 1. Demographics by Sex

Pie chart summarizing how many men and women were in the clinical trials. In total, 960 men (100%) participated in the clinical trial.

FDA Review

Figure 2 summarizes the percentage of patients by race in the clinical trials.

Figure 2. Demographics by Race

Pie chart summarizing how many patients of different races were in the clinical trial. In total, 814 patients were White (85%), 17 patients were Black or African American (2%), 41 patients were Asian (4%), 52 patients were Other (5%), and 36 patients were missing (4%).

*Includes American Indian or Alaska Native (2), Native Hawaiian or Pacific Islander (5) and Other (45).

FDA Review

Figure 3 summarizes the percentage of patients by age group in the clinical trials.

Figure 3. Demographics by Age

Pie chart summarizing how many individuals of certain age groups were in the clinical trial.  In total, 273 patients were less than 65 years old (28%), and 687 patients were 65 years and older (72%).

FDA Review

Figure 4 summarizes the percentage of patients by ethnicity in the clinical trials.

Figure 4. Demographics by Ethnicity

Pie chart summarizing how many individuals of certain ethnicity groups were in the clinical trial.  In total, 42 patients were Hispanic or Latino (4%), 743 patients were not Hispanic or Latino (78%), and for 175 patients (18%) ethnicity were missing

FDA Review

How were the trials designed?

There were two trials that evaluated benefits and side effects of Ga 68 PSMA-11.

Trial 1 enrolled patients who were recently diagnosed with prostate cancer and were awaiting surgery for the removal of the prostate and the nearby lymph nodes. Trial 2 enrolled patients who were already treated for prostate cancer but had rising PSA levels, suspicious for cancer spreading.

The benefit of Ga 68 PSMA-11 in Trial 1 was evaluated by measuring the successful detection of cancer lesions using Ga 68 PSMA-11 PET/CT imaging in comparison to post-surgery lymph tissue results (histopathology of the lymph nodes).

The benefit of Ga 68 PSMA-11 in Trial 2 was evaluated by comparing the agreement in cancer lesion detection between images done with Ga 68 PSMA-11 and one of the standard tests for detecting cancer spreading.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

PRESCRIBING INFORMATION

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