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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-00040 | Registry Identifier | NCI Clinical Trials Reporting Program |
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The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate its ability to detection prostate cancer in patients with biochemical recurrence after prostatectomy and radiation therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ga-68 labeled PSMA-11 PET | Experimental | PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ga-68 labeled PSMA-11 PET | Drug | Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| True Positive Rate for Detection of Tumor Location in Lymph Nodes Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up | The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the lymph nodes using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method. | 1 Day |
| True Positive Rate for Detection of Tumor Location in Visceral Tissue Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up | The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the visceral tissue using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method. | 1 Day |
| True Positive Rate for Detection of Tumor Location in Bone Tissue Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up | The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the bone tissue using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method. | 1 Day |
| True Positive Rate for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up | The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the prostate bed using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method. |
| Measure | Description | Time Frame |
|---|---|---|
| Positive Predictive Value (PPV) for Detection of Tumor Location in Lymph Nodes Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up. | Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the lymph nodes as confirmed by by histopathology/biopsy, clinical and conventional imaging follow-up. | 1 Day |
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Inclusion Criteria
Histopathologically proven prostate adenocarcinoma.
Rising prostate-specific antigen (PSA) (at least two consecutive rising PSAs) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation for biochemical recurrence after radical prostatectomy
Post-radiation therapy -ASTRO-Phoenix consensus definition of biochemical recurrence after radiation therapy
Karnofsky performance status of > 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent).
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 |
|---|---|---|
| Thomas Hope, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32808077 | Derived | Fendler WP, Calais J, Eiber M, Simko JP, Kurhanewicz J, Santos RD, Feng FY, Reiter RE, Rettig MB, Nickols NG, Kishan AU; PSMA PET Reader Group; Slavik R, Carroll PR, Lawhn-Heath C, Herrmann K, Czernin J, Hope TA. False positive PSMA PET for tumor remnants in the irradiated prostate and other interpretation pitfalls in a prospective multi-center trial. Eur J Nucl Med Mol Imaging. 2021 Feb;48(2):501-508. doi: 10.1007/s00259-020-04945-1. Epub 2020 Aug 17. | |
| 30920593 |
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De-identified datasets were made available to collaborating researchers
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| ID | Title | Description |
|---|---|---|
| FG000 | Ga-68 Labeled PSMA-11 PET | PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later. Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ga-68 Labeled PSMA-11 PET | PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later. Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | True Positive Rate for Detection of Tumor Location in Lymph Nodes Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up | The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the lymph nodes using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method. | Data on clinical and conventional imaging follow-up not collected | Posted | 1 Day |
|
Up to 30 days
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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 | Ga-68 Labeled PSMA-11 PET | PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later. Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol. |
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Only a small sample of participants had viable tissue for histological confirmation outcomes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thomas Hope, MD | University of California, San Francisco | (415) 221-4810 | thomas.hope@ucsf.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 | Aug 27, 2017 | Aug 3, 2021 | 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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| 1 day |
| PPV for Detection of Tumor Location in Visceral Lesions Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up. | Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in visceral tissue as confirmed by by histopathology/biopsy, clinical and conventional imaging follow-up. | 1 Day |
| PPV for Detection of Tumor Location in Bone Metastasis Lesions Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up. | Positive predictive value is the probability that participants with a positive reading truly have prostate cancer metastasized in the bone as confirmed by by histopathology/biopsy, clinical and conventional imaging follow-up. | 1 Day |
| PPV for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up. | Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the prostate bed as confirmed by by histopathology/biopsy, clinical and conventional imaging follow-up. | 1 Day |
| True Positive Rate for Detection of Tumor Location in Lymph Nodes Confirmed by Histology/Pathology Only | The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the lymph nodes using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy only. | 1 Day |
| True Positive Rate for Detection of Tumor Location in Visceral Tissue Confirmed by Histology/Pathology Only | The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the visceral tissue using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy only. | 1 Day |
| True Positive Rate for Detection of Tumor Location in Bone Tissue Confirmed by Histology/Pathology Only | The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the bone tissue using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy only. | 1 Day |
| True Positive Rate for Detection of Tumor Location in Prostate Bed Confirmed by Histology/Pathology Only | The true positive rate or detection rate is defined as the proportion of all participants who have prostate cancer detected in the prostate bed using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy only. | 1 Day |
| PPV for Detection of Tumor Location in Lymph Nodes Confirmed by Histopathology/Biopsy Only | Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the lymph nodes as confirmed by by histopathology/biopsy | 1 Day |
| PPV for Detection of Tumor Location in Visceral Tissue Confirmed by Histopathology/Biopsy Only | Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the visceral tissue as confirmed by by histopathology/biopsy | 1 Day |
| PPV for Detection of Tumor Location in Bone Tissue Confirmed by Histopathology/Biopsy Only | Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the bone tissue as confirmed by by histopathology/biopsy | 1 Day |
| PPV for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy Only | Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the prostate bed as confirmed by by histopathology/biopsy | 1 Day |
| Detection Rate of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value | Detection rate (sensitivity) on a per-patient basis of 68Ga-PSMA-11 PET stratified by PSA value (0.2- <0.5, 0.5 - <1.0, 1.0 - <2.0, 2.0 - <5.0, >=5.0) will be summarized in tabular format for participants with PSMA positive disease, independent of pathology, imaging or clinical follow-up. | 1 Day |
| Detection Rate of 68Ga-PSMA-11 PET Stratified by Prior Cancer Treatment | Detection rates (sensitivity) on a per-patient basis of 68Ga-PSMA-11 PET stratified by prior cancer treatment (Prostatectomy, Radiation, or Prostatectomy plus Radiation) will be summarized in tabular format. | 1 Day |
| Detection Rate of 68Ga-PSMA-11 PET Stratified by Prior Use of Androgen Deprivation Therapy (ADT) | Detection rate (sensitivity) on a per-patient basis of 68Ga-PSMA-11 PET stratified by prior use of ADT as a cancer treatment (Prior treatment with ADT, No prior treatment with ADT) will be summarized in tabular format. | 1 Day |
| Percent of Participants With a Change in Clinical Management | Impact of 68Ga-PSMA-11 PET on clinical management in patients with biochemical recurrence (BCR) was measured using Pre-PET (Q1), post-PET (Q2), and post-treatment (Q3) questionnaires sent to referring physicians recording site of recurrence and intended (Q1 to Q2 change) and implemented (Q3) therapeutic and diagnostic management. Percentage of participants with a change in clinical management will be reported using descriptive statistics based on qualitative physician responses from the change in management surveys. | Up to 6 months |
| Rate of Inter-reader Reproducibility for Positivity | Inter-reader reproducibility for positivity at the patient level will be reported using the Fleiss' Kappa test for multiple readers | 1 Day |
| Number of Participants With Grade 3 or Higher, Treatment-related Adverse Events | All grade 3 and above adverse events will be recorded using the NCI CTCAE v4.0. The Investigator will assign attribution of the possible association of the event with use of the investigational drug. | Up to 30 days |
| Derived |
| Fendler WP, Calais J, Eiber M, Flavell RR, Mishoe A, Feng FY, Nguyen HG, Reiter RE, Rettig MB, Okamoto S, Emmett L, Zacho HD, Ilhan H, Wetter A, Rischpler C, Schoder H, Burger IA, Gartmann J, Smith R, Small EJ, Slavik R, Carroll PR, Herrmann K, Czernin J, Hope TA. Assessment of 68Ga-PSMA-11 PET Accuracy in Localizing Recurrent Prostate Cancer: A Prospective Single-Arm Clinical Trial. JAMA Oncol. 2019 Jun 1;5(6):856-863. doi: 10.1001/jamaoncol.2019.0096. |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
| Primary | True Positive Rate for Detection of Tumor Location in Visceral Tissue Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up | The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the visceral tissue using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method. | Data on clinical and conventional imaging follow-up not collected | Posted | 1 Day |
|
|
| Primary | True Positive Rate for Detection of Tumor Location in Bone Tissue Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up | The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the bone tissue using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method. | Data on clinical and conventional imaging follow-up not collected | Posted | 1 Day |
|
|
| Primary | True Positive Rate for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up | The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the prostate bed using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method. | Data on clinical and conventional imaging follow-up not collected | Posted | 1 day |
|
|
| Secondary | Positive Predictive Value (PPV) for Detection of Tumor Location in Lymph Nodes Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up. | Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the lymph nodes as confirmed by by histopathology/biopsy, clinical and conventional imaging follow-up. | Data on clinical and conventional imaging follow-up not collected | Posted | 1 Day |
|
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| Secondary | PPV for Detection of Tumor Location in Visceral Lesions Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up. | Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in visceral tissue as confirmed by by histopathology/biopsy, clinical and conventional imaging follow-up. | Data on clinical and conventional imaging follow-up not collected | Posted | 1 Day |
|
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| Secondary | PPV for Detection of Tumor Location in Bone Metastasis Lesions Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up. | Positive predictive value is the probability that participants with a positive reading truly have prostate cancer metastasized in the bone as confirmed by by histopathology/biopsy, clinical and conventional imaging follow-up. | Data on clinical and conventional imaging follow-up not collected | Posted | 1 Day |
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| Secondary | PPV for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up. | Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the prostate bed as confirmed by by histopathology/biopsy, clinical and conventional imaging follow-up. | Data on clinical and conventional imaging follow-up not collected | Posted | 1 Day |
|
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| Secondary | True Positive Rate for Detection of Tumor Location in Lymph Nodes Confirmed by Histology/Pathology Only | The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the lymph nodes using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy only. | Only 7 participants had adequate histology/biopsy data for this analysis | Posted | Number | proportion of participants | 1 Day |
|
|
|
| Secondary | True Positive Rate for Detection of Tumor Location in Visceral Tissue Confirmed by Histology/Pathology Only | The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the visceral tissue using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy only. | Only 9 participants had adequate histology/biopsy data for this analysis | Posted | Number | proportion of participants | 1 Day |
|
|
|
| Secondary | True Positive Rate for Detection of Tumor Location in Bone Tissue Confirmed by Histology/Pathology Only | The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the bone tissue using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy only. | Only 2 participants had adequate histology/biopsy data for this analysis | Posted | Number | proportion of participants | 1 Day |
|
|
|
| Secondary | True Positive Rate for Detection of Tumor Location in Prostate Bed Confirmed by Histology/Pathology Only | The true positive rate or detection rate is defined as the proportion of all participants who have prostate cancer detected in the prostate bed using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy only. | Only 30 participants had adequate histology/biopsy data for this analysis | Posted | Number | proportion of participants | 1 Day |
|
|
|
| Secondary | PPV for Detection of Tumor Location in Lymph Nodes Confirmed by Histopathology/Biopsy Only | Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the lymph nodes as confirmed by by histopathology/biopsy | Only 7 participants had adequate histology/biopsy data for this analysis | Posted | Number | proportion | 1 Day |
|
|
|
| Secondary | PPV for Detection of Tumor Location in Visceral Tissue Confirmed by Histopathology/Biopsy Only | Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the visceral tissue as confirmed by by histopathology/biopsy | Only 9 participants had adequate histology/biopsy data for this analysis | Posted | Number | proportion | 1 Day |
|
|
|
| Secondary | PPV for Detection of Tumor Location in Bone Tissue Confirmed by Histopathology/Biopsy Only | Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the bone tissue as confirmed by by histopathology/biopsy | Only 2 participants had adequate histology/biopsy data for this analysis | Posted | Number | proportion | 1 Day |
|
|
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| Secondary | PPV for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy Only | Positive predictive value is the probability that participants with a positive reading truly have prostate cancer in the prostate bed as confirmed by by histopathology/biopsy | Only 30 participants had adequate histology/biopsy data for this analysis | Posted | Number | proportion | 1 Day |
|
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| Secondary | Detection Rate of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value | Detection rate (sensitivity) on a per-patient basis of 68Ga-PSMA-11 PET stratified by PSA value (0.2- <0.5, 0.5 - <1.0, 1.0 - <2.0, 2.0 - <5.0, >=5.0) will be summarized in tabular format for participants with PSMA positive disease, independent of pathology, imaging or clinical follow-up. | The number analyzed per row represents the number of participants in each category | Posted | Number | proportion of participants | 1 Day |
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| Secondary | Detection Rate of 68Ga-PSMA-11 PET Stratified by Prior Cancer Treatment | Detection rates (sensitivity) on a per-patient basis of 68Ga-PSMA-11 PET stratified by prior cancer treatment (Prostatectomy, Radiation, or Prostatectomy plus Radiation) will be summarized in tabular format. | Prior cancer treatment for only 287 evaluable participants was collected. The number analyzed per row represents the number of participants in each category. | Posted | Number | proportion of participants | 1 Day |
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| Secondary | Detection Rate of 68Ga-PSMA-11 PET Stratified by Prior Use of Androgen Deprivation Therapy (ADT) | Detection rate (sensitivity) on a per-patient basis of 68Ga-PSMA-11 PET stratified by prior use of ADT as a cancer treatment (Prior treatment with ADT, No prior treatment with ADT) will be summarized in tabular format. | Prior ADT treatment for only 272 evaluable participants was collected. The number analyzed per row represents the number of participants in each category. | Posted | Number | proportion of participants | 1 Day |
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| Secondary | Percent of Participants With a Change in Clinical Management | Impact of 68Ga-PSMA-11 PET on clinical management in patients with biochemical recurrence (BCR) was measured using Pre-PET (Q1), post-PET (Q2), and post-treatment (Q3) questionnaires sent to referring physicians recording site of recurrence and intended (Q1 to Q2 change) and implemented (Q3) therapeutic and diagnostic management. Percentage of participants with a change in clinical management will be reported using descriptive statistics based on qualitative physician responses from the change in management surveys. | Data on change in clinical management not collected for this sample | Posted | Up to 6 months |
|
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| Secondary | Rate of Inter-reader Reproducibility for Positivity | Inter-reader reproducibility for positivity at the patient level will be reported using the Fleiss' Kappa test for multiple readers | Inter-reader reproducibility data not collected | Posted | 1 Day |
|
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| Secondary | Number of Participants With Grade 3 or Higher, Treatment-related Adverse Events | All grade 3 and above adverse events will be recorded using the NCI CTCAE v4.0. The Investigator will assign attribution of the possible association of the event with use of the investigational drug. | Posted | Count of Participants | Participants | Up to 30 days |
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| 0 |
| 346 |
| 0 |
| 346 |
| 0 |
| 346 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
|
| PSA = 1.0 - <2.0 |
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| PSA = 2.0 - <5.0 |
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| PSA >= 5.0 |
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| Prostatectomy and salvage radiation therapy |
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