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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient participants | Experimental | PET/CT imaging |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-PSMA | Drug | PET/CT imaging with 68Ga-PSMA: 68Ga-PSMA is an investigational radioactive drug that binds to receptors on prostate cancer cells. The intravenously administered drug dose will be about 5 mCi (range 3-7 mCi). |
| Measure | Description | Time Frame |
|---|---|---|
| Positive Predictive Value (PPV) of 68Ga PSMA PET/CT for Detecting Prostate Cancer on a Per-patient Basis Confirmed by Histopathology. | Evaluation of the positive predictive value (PPV) (true positives / (true positives + false positives)) of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by histopathology on a per-patient basis. On a per-patient basis, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%. The result of a histopathological examination of a PSMA positive lesion is obtained when available. Such data are collected as a single time point up to 12 months following the scan. | Up to 12 months after 68Ga-PSMA scan |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and PPV on a Per-patient and Per-region-basis of 68Ga-PSMA PET/CT for Detection of Tumor Location. | The sensitivity and PPV of 68Ga-PSMA PET/CT is determined on a per-patient and per-region-basis for the detection of tumor location. Confirmation is obtained by conventional imaging, clinical follow-up, and/or histopathology/biopsy where available. Results of conventional imaging, clinical follow-up, and/or histopathology is collected as a single time point up to 12 months following the scan. |
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Inclusion Criteria:
Histopathological proven prostate adenocarcinoma.
Rising prostate specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
Karnofsky performance status of ≥ 50.
Age ≥ 18.
Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Morand R Piert, M.D. | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34326126 | Result | Abghari-Gerst M, Armstrong WR, Nguyen K, Calais J, Czernin J, Lin D, Jariwala N, Rodnick M, Hope TA, Hearn J, Montgomery JS, Alva A, Reichert ZR, Spratt DE, Johnson TD, Scott PJH, Piert M. A Comprehensive Assessment of 68Ga-PSMA-11 PET in Biochemically Recurrent Prostate Cancer: Results from a Prospective Multicenter Study on 2,005 Patients. J Nucl Med. 2022 Apr;63(4):567-572. doi: 10.2967/jnumed.121.262412. Epub 2021 Jul 29. |
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Codified data will be archived and stored in an imaging repository with limited metadata for analysis. Individuals seeking use of these data should contact the study chair. A data sharing contract for a HIPAA limited dataset will need to be executed prior to data sharing.
Available as requested. Data will be archived indefinitely for research purposes.
Individuals seeking use of these data should contact the study chair.
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| ID | Title | Description |
|---|---|---|
| FG000 | 68Ga-PSMA | Participants in this arm were prostate cancer patients who experienced elevated PSA after definitive therapy with prostatectomy, radiation therapy (external beam or brachytherapy), or focal therapy of the prostate. |
| FG001 | Physicians | Participants were the ordering physicians/practitioners of the patient participants in the 68Ga-PSMA study arm. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 68Ga-PSMA | Participants in this arm were prostate cancer patients who experienced elevated PSA after definitive therapy with prostatectomy, radiation therapy (external beam or brachytherapy), or focal therapy of the prostate. |
| BG001 | Physicians |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age data not collected for the Physicians Arm |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Positive Predictive Value (PPV) of 68Ga PSMA PET/CT for Detecting Prostate Cancer on a Per-patient Basis Confirmed by Histopathology. | Evaluation of the positive predictive value (PPV) (true positives / (true positives + false positives)) of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by histopathology on a per-patient basis. On a per-patient basis, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%. The result of a histopathological examination of a PSMA positive lesion is obtained when available. Such data are collected as a single time point up to 12 months following the scan. | The participants analyzed were all those who had histopathological confirmation. Participants in this arm were prostate cancer patients who experienced elevated PSA after definitive therapy with prostatectomy, radiation therapy (external beam or brachytherapy), or focal therapy of the prostate. | Posted | Number | 95% Confidence Interval | percentage of times value is true | Up to 12 months after 68Ga-PSMA scan |
|
Patients were monitored for adverse events during and for 90 minutes after 68Ga-PSMA-11 administration. Patients were also contacted by phone to assess for the development of delayed adverse events up 3 days after 68Ga-PSMA-11 administration.
Physicians received no intervention; therefore no adverse event data were collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 68Ga-PSMA | Participants in this arm were prostate cancer patients who experienced elevated PSA after definitive therapy with prostatectomy, radiation therapy (external beam or brachytherapy), or focal therapy of the prostate. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | Non-systematic Assessment | Subject with history of coronary artery disease and aortic stenosis developed chest pain during the research scan and was hospitalized. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Cardiac disorders | Non-systematic Assessment | Subject became dizzy and had balance problems following the research scan. Went to the emergency room and was further managed with medication. |
For Outcome Measure 5, a quality check was performed of the results by analyzing electronic medical records. The analysis showed the questionnaire responses about treatment plans collected post-scan did not align with the actual treatments listed in the medical records.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Morand Piert | University of Michigan | 734-936-5385 | mpiert@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 13, 2019 | Jul 18, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000718244 | gallium 68 PSMA-11 |
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|
| Up to 12 months after 68Ga-PSMA scan |
| Adverse Events of 68Ga-PSMA Administration | The number of adverse events were determined through clinical assessment and categorized by CTCAE 4.0. | 24 - 72 hours post administration |
| Detection Rates on a Per-patient Basis of 68Ga-PSMA-11 PET/CT | Scan detection rates (in %) on a per-patient basis are given for specific PSA value ranges (a) 0.2<0.5, b) 0.5<1.0, c) 1.0<2.0, d) 2.0<5.0, e) >=5.0 ng/mL. Ideally, the 68Ga-PSMA-11 PET/CT scan detection rate would be 100% at any PSA range. | 12 months post scan |
| Impact of 68Ga-PSMA-11 PET on Clinical Management in BCR Patients | The results of this outcome measure were evaluated using a treatment plan questionnaire given to the treating physician or practitioner before the scan, at approximately 1 month (2-30 days) after the 68Ga-PSMA-11 PET scan, and at approximately 6 months (range 3 - 12 months) after the 68Ga-PSMA-11 PET scan. The treatment plan questionnaire was provided with 11 choice options. Responses to the questionnaire were compared to determine whether physicians changed their treatment plans following the PET scan. | 2 days to 12 months following the scan. |
Participants were the ordering physicians/practitioners of the patient participants in the 68Ga-PSMA study arm. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Sex: all male given disease (prostate cancer participants). Sex data not collected for the Physicians Arm. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Ethnicity data not collected for the Physicians Arm | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race data not collected for the Physicians Arm | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Weight | Weight data not collected for the Physicians Arm | Mean | Standard Deviation | kg |
|
| Height | Height data not collected for the Physicians Arm | Mean | Standard Deviation | cm |
|
| Description |
|---|
| OG000 | 68Ga-PSMA | PET/CT imaging 68Ga-PSMA: PET/CT imaging with 68Ga-PSMA: 68Ga-PSMA is an investigational radioactive drug that binds to receptors on prostate cancer cells. The intravenously administered drug dose will be about 5 mCi (range 3-7 mCi). |
|
|
|
| Secondary | Sensitivity and PPV on a Per-patient and Per-region-basis of 68Ga-PSMA PET/CT for Detection of Tumor Location. | The sensitivity and PPV of 68Ga-PSMA PET/CT is determined on a per-patient and per-region-basis for the detection of tumor location. Confirmation is obtained by conventional imaging, clinical follow-up, and/or histopathology/biopsy where available. Results of conventional imaging, clinical follow-up, and/or histopathology is collected as a single time point up to 12 months following the scan. | Participants analyzed were all those where either conventional imaging, clinical follow-up, or histopathology was available. Participants in this arm were prostate cancer patients who experienced elevated PSA after definitive therapy with prostatectomy, radiation therapy (external beam or brachytherapy), or focal therapy of the prostate. | Posted | Number | 95% Confidence Interval | percentage of times value is true | Up to 12 months after 68Ga-PSMA scan |
|
|
|
|
| Secondary | Adverse Events of 68Ga-PSMA Administration | The number of adverse events were determined through clinical assessment and categorized by CTCAE 4.0. | Participants in this arm were prostate cancer patients who experienced elevated PSA after definitive therapy with prostatectomy, radiation therapy (external beam or brachytherapy), or focal therapy of the prostate and received a 68Ga-PSMA-11 PET/CT scan. | Posted | Number | events | 24 - 72 hours post administration |
|
|
|
| Secondary | Detection Rates on a Per-patient Basis of 68Ga-PSMA-11 PET/CT | Scan detection rates (in %) on a per-patient basis are given for specific PSA value ranges (a) 0.2<0.5, b) 0.5<1.0, c) 1.0<2.0, d) 2.0<5.0, e) >=5.0 ng/mL. Ideally, the 68Ga-PSMA-11 PET/CT scan detection rate would be 100% at any PSA range. | Participants in this arm were prostate cancer patients who experienced elevated PSA after definitive therapy with prostatectomy, radiation therapy, or focal therapy of the prostate. | Posted | Number | percentage of positive scans | 12 months post scan |
|
|
|
| Secondary | Impact of 68Ga-PSMA-11 PET on Clinical Management in BCR Patients | The results of this outcome measure were evaluated using a treatment plan questionnaire given to the treating physician or practitioner before the scan, at approximately 1 month (2-30 days) after the 68Ga-PSMA-11 PET scan, and at approximately 6 months (range 3 - 12 months) after the 68Ga-PSMA-11 PET scan. The treatment plan questionnaire was provided with 11 choice options. Responses to the questionnaire were compared to determine whether physicians changed their treatment plans following the PET scan. | The intention was to count the number of prostate cancer patients and whether their treatment plans changed post scan based on physician survey responses and the participant's electronic medical record. Not all the physicians responded to surveys, and electronic records were not available for all participants, meaning data are missing for some patients. | Posted | Count of Participants | Participants | 2 days to 12 months following the scan. |
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| 0 |
| 1,181 |
| 1 |
| 1,181 |
| 2 |
| 1,181 |
|
|
| Pain | General disorders | Non-systematic Assessment | Patient developed pain due to positioning with his arms up during the imaging scan. |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
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| More than one race |
|
| Unknown or Not Reported |
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| Sensitivity, prostate or prostate bed |
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| PPV, pelvic lymph nodes |
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| Sensitivity, pelvic lymph nodes |
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| PPV, soft tissues |
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| Sensitivity, soft tissues |
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| PPV, bone |
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| Sensitivity, bone |
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| Superiority |
Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16) |
| Sensitivity, composite standard, per-patient basis: We determined the sensitivity of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy (composite standard of truth). On a per-patient basis, the sensitivity of conventional imaging ranges between 30-50%. The null hypothesis is that the sensitivity at 50% will be tested against the alternative hypothesis that the sensitivity is greater than 50%. | Sensitivity | <0.0000001 | Per patient basis p-value = 2.2e-16 | Sensitivity | 95.29 | 2-Sided | 95 | 93.3 | 100.00 | Other | Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16) |
| PPV, composite standard, prostate or prostate bed: PPV of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy where available (composite standard of truth). In the prostate or prostate bed, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%. | Exact binomial proportion test | <0.0000001 | p-value = 2.2e-16 | Sensitivity | 91.1 | 2-Sided | 95 | 86.2 | 100.00 | Superiority | Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16) |
| Sensitivity, composite standard, prostate/prostate bed: We determined the sensitivity of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy (composite standard of truth). In the prostate or prostate bed, the sensitivity of conventional imaging ranges between 30-50%. The null hypothesis is that the sensitivity at 50% will be tested against the alternative hypothesis that the sensitivity is greater than 50%. | Exact binomial proportion test | <0.0000001 | p-value = 2.2e-16 Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16) | Sensitivity | 91.72 | 2-Sided | 95 | 86.74 | 100.00 | Other | Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16) |
| PPV, composite standard, pelvic lymph nodes: PPV of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy where available (composite standard of truth). In the prostate or prostate bed, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%. | Exact binomial proportion test | <0.0000001 | p-value = 2.2e-16 | PPV | 90.78 | 2-Sided | 95 | 85.74 | 100.00 | Other | Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16) |
| Sensitivity, composite standard, pelvic lymph nodes: We determined the sensitivity of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy (composite standard of truth). In pelvic lymph nodes, the sensitivity of conventional imaging ranges between 30-50%. The null hypothesis is that the sensitivity at 50% will be tested against the alternative hypothesis that the sensitivity is greater than 50%. | Exact binomial proportion test | <0.0000001 | p-value = 2.2e-16 | Sensitivity | 96.97 | 2-Sided | 95 | 93.20 | 100.00 | Superiority | Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16) |
| PPV, composite standard, soft tissues: PPV of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy where available (composite standard of truth). In soft tissues, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%. | Exact binomial proportion test | <0.0000001 | p-value = 2.9e-15 | PPV | 91.25 | 2-Sided | 95 | 84.19 | 100.00 | Superiority | Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16) |
| Sensitivity, composite standard, soft tissues: We determined the sensitivity of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy (composite standard of truth). In soft tissues, the sensitivity of conventional imaging ranges between 30-50%. The null hypothesis is that the sensitivity at 50% will be tested against the alternative hypothesis that the sensitivity is greater than 50%. | Exact binomial proportion test | <0.0000001 | p-value = 2.2e-16 | Sensitivity | 93.59 | 2-Sided | 95 | 86.99 | 100.00 | Superiority | Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16) |
| PPV, composite standard, bone: PPV of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy where available (composite standard of truth). In bone tissues, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%. | Exact binomial proportion test | <0.0000001 | p-value = 2.2e-16 | PPV | 95.17 | 2-Sided | 95 | 91.12 | 100.00 | Superiority | Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16) |
| Sensitivity, composite standard, bone: We determined the sensitivity of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy (composite standard of truth). In bone, the sensitivity of conventional imaging ranges between 30-50%. The null hypothesis is that the sensitivity at 50% will be tested against the alternative hypothesis that the sensitivity is greater than 50%. | Exact binomial proportion test | <0.0000001 | p-value = 2.2e-16 | Sensitivity | 100 | 2-Sided | 95 | 97.85 | 100.00 | Superiority | Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16) |
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| PSA range 1.0 - < 2.0 ng/mL. |
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| PSA range 2.0 - < 5.0 ng/mL. |
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| PSA range 5.0 and above ng/mL. |
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| Missing Data |
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