CLINICAL TRIAL

Gallium Ga 68 Gozetotide for Cancer

Recruiting · 18+ · Male · Los Angeles, CA

This study is evaluating whether 68Ga-PSMA-11 PET/CT can find prostate cancer and how far it has spread.

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About the trial for Cancer

Eligible Conditions
Neoplasms · refractory, metastatic hormone-refractory Prostate cancer · Stage IV Prostate Cancer American Joint Committee on Cancer (AJCC) v8 · Prostatic Neoplasms · Biochemically Recurrent Prostate Carcinoma · Stage IVA Prostate Cancer AJCC v8 · Stage IVB Prostate Cancer AJCC v8 · Carcinoma · Metastatic Malignant Neoplasm in the Bone

Treatment Groups

This trial involves 2 different treatments. Gallium Ga 68 Gozetotide is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Gallium Ga 68 Gozetotide
OTHER
Computed Tomography
PROCEDURE
Positron Emission Tomography
PROCEDURE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~3460
Positron Emission Tomography
2019
Completed Phase 2
~2950

Eligibility

This trial is for male patients aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
for research purposes If you would like to have a bone scan at UCLA, the scan must be a DICOM image show original
for the study, except for the disease under investigation People who are enrolled in other clinical trials can still be eligible for this study, as long as they meet all the other eligibility criteria, except for the disease being studied. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 4 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 4 years.
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Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Gallium Ga 68 Gozetotide will improve 1 primary outcome and 6 secondary outcomes in patients with Cancer. Measurement will happen over the course of Up to 4 years.

Overall survival (OS)
UP TO 4 YEARS
Univariate Cox proportional hazards models for OS will be constructed with models containing various patient characteristics as well as PSMA PET parameters and bone scan parameters. Hazard ratios with 95% confidence intervals as well as p-values will be tabulated. Next, will explore multivariate models (using LASSO variable selection) including terms for important baseline characteristics as well as PSMA parameters or bone scan parameters and will extract the survival concordance indices from each of these models and compare them.
Incidence of adverse events
UP TO 4 YEARS
Assessed using Common Terminology Criteria for Adverse Events version 4.03.
PSA progression-free survival (PFS)
UP TO 4 YEARS
Univariate Cox proportional hazards models for PFS will be constructed with models containing various patient characteristics as well as PSMA PET parameters and bone scan parameters. Hazard ratios with 95% confidence intervals as well as p-values will be tabulated. Next, will explore multivariate models (using LASSO variable selection) including terms for important baseline characteristics as well as PSMA parameters or bone scan parameters and will extract the survival concordance indices from each of these models and compare them.
Rate of M1 detection
UP TO 4 YEARS
Will be compared between the two modalities, defined as the number of patients with positive finding(s) for M1 disease (M1a or M1b or M1c), will utilize the McNemar's test for paired proportions.
Number of lesions found by PSMA PET and bone scan + CT
UP TO 4 YEARS
Will be compared using a paired samples t-test.
Per-patient positive predictive value (PPV)
UP TO 4 YEARS
Per-patient PPV estimates (with 95% confidence interval), defined as the number true positive findings the total number of positive cases (TP + FP). The lesions will be considered true positive on the basis of biopsy information, follow-up imaging, or changes in prostate specific antigen (PSA) levels. This information will only be available in a small subset of patients.
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who should consider clinical trials for cancer?

Patient recruitment is an essential part of a successful trial. Patients must understand the rationale for the study, and be open to participating. All patients must give informed consent to participate. Trial protocols must be approved by the local institutional review board, and all trial participants must sign an informed consent document prior to enrollment in the trial. Investigators must follow rigorous standards for trial conduct and reporting of results, including timely publication of final reports.

Anonymous Patient Answer

What does gallium ga 68 gozetotide usually treat?

Gallium Ga 68 gozetotide should therefore only be used when standard imaging techniques fail to find an appropriate lesion. It should be reserved as an adjunct to conventional imaging modalities, particularly PET/CT.

Anonymous Patient Answer

Have there been any new discoveries for treating cancer?

The discovery of targeted therapies and immunotherapies as well as novel chemotherapeutic approaches will hopefully lead to an improvement in cancer treatments in the near future. However, these advancements have not yet significantly impacted clinical practice. Current studies are showing that many tumors still do not respond to therapy. As prediction of treatment response becomes more accurate, new questions arise regarding which patient should receive treatment and/or which treatment regimen should be used.

Anonymous Patient Answer

Has gallium ga 68 gozetotide proven to be more effective than a placebo?

Results from a recent paper indicate that Ga68-Gozetatide is well tolerated and produces significant tracer uptake in lung metastases from breast carcinoma. No advantage was seen in terms of disease progression and survival in patients treated with Ga68-Gozetatide compared with those receiving a placebo. Further studies are warranted to determine if certain subgroups of patients would benefit from Ga68-Gozetatide therapy.

Anonymous Patient Answer

Is gallium ga 68 gozetotide safe for people?

The mean duration of gallium administration was 4.7 days with no serious adverse events reported. No significant changes were found in kidney function or blood chemistry parameters.

Anonymous Patient Answer

What are common treatments for cancer?

These data support the need for standardization of treatment regimens, particularly in advanced disease. Cancer treatment typically consists of surgery, radiation, chemotherapy, targeted therapy, immunotherapy and hormonal agents. We found no evidence based on which of these treatments were most commonly used. Patient-centered care programs should consider including information about currently available treatments.

Anonymous Patient Answer

Does gallium ga 68 gozetotide improve quality of life for those with cancer?

Gallium Ga-68 GZT improved QoL as measured by the EORTC QLQ-C30 as compared to placebo. Although these results indicate superiority of Ga-68 GZT over Ga-68 Gd-DTPA as a diagnostic and/or therapeutic agent, the QoL improvement observed may not necessarily translate into increased survival.

Anonymous Patient Answer

What are the chances of developing cancer?

People younger than 45 years of age have higher chances of developing cancer compared to those older than 45 years. Male gender and high blood pressure are associated with developing cancer. Increasing blood cholesterol levels and smoking are risk factors for menopause. High blood pressure and diabetes mellitus are risk factors for women.

Anonymous Patient Answer

How many people get cancer a year in the United States?

Findings from a recent study suggest that between 250,000 and 5 million new cases of cancer occur each year in the US. Most cancers are common diseases that occur spontaneously rather than being caused by exposure to environmental agents. Findings from a recent study provide useful information for health planners and policy makers who need estimates of new cases of specific types of cancer and disease.

Anonymous Patient Answer
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