Gallium Ga 68-labeled PSMA-11 PET/CT in Detecting Recurrent Prostate Cancer in Patients After Initial Therapy
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| ClinicalTrials.gov Identifier: NCT02940262 |
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Recruitment Status :
Completed
First Posted : October 20, 2016
Last Update Posted : July 2, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prostate Adenocarcinoma Recurrent Prostate Carcinoma | Radiation: Gallium Ga 68 Gozetotide Other: Laboratory Biomarker Analysis Procedure: Positron Emission Tomography | Phase 3 |
PRIMARY OBJECTIVE:
I. To assess the sensitivity on a per-patient and per-region-basis of Gallium Ga 68 Gozetotide (68Ga-PSMA-11) PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.
SECONDARY OBJECTIVES:
I. To assess the positive predictive value (PPV) on a per-patient and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up (composite reference standard).
II. To assess the sensitivity and positive predictive value (PPV) on a per-patient and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy only.
III. To assess the detection rates on a per-patient basis of 68Ga-PSMA-11 PET stratified by prostate specific antigen (PSA) value (0.2 - < 0.5, 0.5 - < 1.0, 1.0 - < 2.0, 2.0 - < 5.0, >= 5.0).
IV. To assess the impact of 68Ga-PSMA-11 PET on clinical management in biochemical recurrence (BCR) patients.
V. To assess the inter-reader reproducibility. VI. To assess the safety of 68Ga-PSMA-11 PET. VII. To assess the detection rates on a per-patient basis of 68Ga-PSMA-11 PET stratified by PSA velocity and PSA doubling-time.
OUTLINE:
Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV). Beginning 50-100 minutes after receiving gallium Ga 68-labeled PSMA-11, patients undergo PET imaging.
After completion of study, patients are followed up for 3-12 months.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1138 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | 68Ga-PSMA PET/CT for Detection of Recurrent Prostate Cancer After Initial Therapy |
| Actual Study Start Date : | September 15, 2016 |
| Actual Primary Completion Date : | June 18, 2021 |
| Actual Study Completion Date : | June 18, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Treatment (68Ga-PSMA-11)
Patients receive gallium Ga 68-labeled PSMA-11 IV. Beginning 50-100 minutes after receiving gallium Ga 68-labeled PSMA-11, patients undergo PET imaging.
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Radiation: Gallium Ga 68 Gozetotide
Given IV
Other Names:
Other: Laboratory Biomarker Analysis Correlative studies Procedure: Positron Emission Tomography Undergo PET imaging
Other Names:
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- Sensitivity on a per-patient and per-region-basis of gallium Ga 68-labeled PSMA-11 positron emission tomography for detection of tumor location [ Time Frame: Up to 12 months ]Confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Will be calculated and reported along with the corresponding two-sided 95% confidence intervals. The confidence intervals will be constructed using the Wilson score method.
- Positive predictive value (PPV) on a per-patient and per-region-basis of gallium Ga 68-labeled PSMA-11 positron emission tomography for detection of tumor location [ Time Frame: Up to 12 months ]Confirmed by histopathology/biopsy and, clinical and conventional imaging follow-up. Will be calculated and reported along with the corresponding two-sided 95% confidence intervals. The paired McNemar's test will be used to compare the positive predictive values of gallium Ga 68-labeled PSMA-11 positron emission tomography imaging to the positive predictive values of conventional imaging.
- Sensitivity and PPV on a per-patient and per-region-basis of 68Ga-PSMA-11 positron emission tomography (PET) for detection of tumor location confirmed by histopathology/biopsy [ Time Frame: Up to 12 months ]Will be summarized in tabular format. Ninety-five confidence intervals of sensitivity, specificity, and net present value (NPV) will be calculated using the Wilson score method.
- Detection rates on a per-patient basis of gallium Ga 68-labeled PSMA-11 positron emission tomography stratified by PSA value [ Time Frame: Up to 12 months ]Detection rates on a per-patient basis of gallium Ga 68-labeled PSMA-11 positron emission tomography stratified by PSA value (0.2 - < 0.5, 0.5 - < 1.0, 1.0 - < 2.0, 2.0 - < 5.0, >= 5.0) and PSA velocity/doubling-time will be summarized in tabular format and compared between PSA strata using chi-square analysis.
- Detection rates on a per-patient basis of gallium Ga 68-labeled PSMA-11 positron emission tomography stratified by PSA velocity and PSA doubling-time [ Time Frame: Up to 12 months ]Detection rates on a per-patient basis of gallium Ga 68-labeled PSMA-11 positron emission tomography stratified by PSA value (0.2 - < 0.5, 0.5 - < 1.0, 1.0 - < 2.0, 2.0 - < 5.0, >= 5.0) and PSA velocity/doubling-time will be summarized in tabular format and compared between PSA strata using chi-square analysis.
- Clinical management in biochemical recurrence patients [ Time Frame: Up to 12 months ]The impact of gallium Ga 68-labeled PSMA-11 positron emission tomography on clinical management in biochemical recurrence patients will be evaluated using descriptive statistics.
- Inter-reader reproducibility [ Time Frame: Up to 12 months ]Inter-reader reproducibility for positivity at the patient level and region level will be reported using the Fleiss' Kappa test for multiple readers.
- Incidence of adverse events [ Time Frame: Up to 12 months ]Safety will be reported descriptively as rates of patient reported adverse events. Additionally, adverse events will be characterized and quantified by Common Terminology Criteria for Adverse Events 4.03.
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histopathological proven prostate adenocarcinoma
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Rising PSA after definitive therapy with prostatectomy or radiation therapy.
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Post radical prostatectomy (RP)
- PSA equals to or greater than 0.2 ng/mL measured more than 6 weeks after RP
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Post-radiation therapy - American Society for Therapeutic Radiation and Oncology (ASTRO)-Phoenix consensus definition
- Nadir + greater than or equal to 2 ng/mL rise in PSA
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- Karnofsky performance status of >= 50 (or Eastern Cooperative Oncology Group [ECOG]/ World Health Organization [WHO] equivalent)
- Ability to understand a written informed consent document, and the willingness to sign it
Exclusion Criteria:
- Concomitant investigational therapy
- Known inability to lie flat, remain still or tolerate a PET scan
- Patient undergoing active treatment for non-prostate malignancy, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02940262
| United States, California | |
| UCLA / Jonsson Comprehensive Cancer Center | |
| Los Angeles, California, United States, 90095 | |
| Principal Investigator: | Johannes Czernin, MD | UCLA / Jonsson Comprehensive Cancer Center |
| Responsible Party: | Jonsson Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT02940262 |
| Other Study ID Numbers: |
16-001095 NCI-2016-01212 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) |
| First Posted: | October 20, 2016 Key Record Dates |
| Last Update Posted: | July 2, 2021 |
| Last Verified: | June 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Prostatic Neoplasms Adenocarcinoma Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Prostatic Diseases Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Edetic Acid Gallium 68 PSMA-11 Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action Anticoagulants Calcium Chelating Agents Radiopharmaceuticals |