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| ID | Type | Description | Link |
|---|---|---|---|
| CAAA502A12101 | Other Identifier | Novartis |
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This was an open-label, multicenter, single dose, Phase I/II study to evaluate the safety and tolerability of a single administration of 3 mega Becquerel (MBq)/kg, but not less than 150 MBq and not more than 250 MBq, of 68^Ga-PSMA-R2 in adult male patients with biochemical relapse (BR) and metastatic prostate cancer (mPCa).
This study consisted of 2 parts.
This study was comprised of 4 clinical visits and conducted in 3 study periods: screening, administration/imaging, and safety follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | Experimental | All eligible participants received recommended dose of [68Ga]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq]. |
|
| Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | Experimental | All eligible participants received recommended dose of [68Ga]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq]. |
|
| Metastatic Prostate Cancer (mPCa) (Phase II) | Experimental | All eligible participants received recommended dose of [68Ga]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq]. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [68Ga]-PSMA-R2 | Drug | radio-labelled PSMA ligand |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events | Treatment-emergent adverse events (TEAEs) were collected from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent. The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed. | dosing through 28 days post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | PET/CT scans were performed at approximately 20 to 30 min and at 1, 2, 3 to 4 hours postinjection. Time activity curves (TACs) for various organs (Brain, Heart Wall, Kidney, Lacrimal Gland, Liver, Lungs, Salivary Gland, Spleen and Thyroid) were produced as decay-corrected tissue of injected activity (mSv/MBq) per organ. Only descriptive analysis performed. |
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Inclusion Criteria:
Males 18 years or older.
Signed and dated written informed consent by the subject prior to any study-specific procedures.
Histologically confirmed adenocarcinoma of the prostate, defined as follows:
Biochemical recurrence: defined as PSA is ≥0.2 ng/mL after radical prostatectomy or PSA nadir plus 2 ng/mL after radiation therapy with corresponding CT/MRI or bone scan revealing absence of local recurrence or metastatic lesions.
OR
Metastatic disease: defined as both, castration-sensitive or castration-resistant mPCa (presence of at least 1 metastatic lymph node, visceral metastasis and/or bone metastasis).
At least 2 weeks must have elapsed between last anticancer treatment administration and the administration of the imaging product, 68Ga-PSMA-R2.
Prior major surgery must be at least 12 weeks prior to study entry.
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2, with a life expectancy ≥6 months.
Adequate bone marrow reserve and organ function as demonstrated by complete blood count, and biochemistry in blood and urine at Screening:
Serum creatinine <1.5*upper limit normal (ULN) or estimated glomerular filtration rate (eGFR) >50 mL/min based upon The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
For male subjects with partners of childbearing potential, agreement to use barrier contraceptive method (condom) and to continue its use for 28 days after IP administration.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pheonix Molecular Imaging Center | Phoenix | Arizona | 85040 | United States | ||
| University of California, San Francisco (UCSF) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39915126 | Derived | Lindenberg L, Hope TA, Lin FI, Rowe SP, Pucar D, Gilbert N, Chicco D, He B, Feuerecker B, Castaldi E, Solnes LB. Safety, Dosimetry, and Feasibility of [68Ga]Ga-PSMA-R2 as an Imaging Agent in Patients with Biochemical Recurrence or Metastatic Prostate Cancer. J Nucl Med. 2025 Mar 3;66(3):359-365. doi: 10.2967/jnumed.124.268318. |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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This study was conducted at 5 centers in the USA (Phase I: 1 site; Phase II: 4 sites)
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| ID | Title | Description |
|---|---|---|
| FG000 | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | All eligible participants received recommended dose of [68Ga]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq]. |
| FG001 | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | All eligible participants received recommended dose of [68Ga]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq]. |
| FG002 | Metastatic Prostate Cancer (mPCa) (Phase II) | All eligible participants received recommended dose of [68Ga]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq]. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | All eligible participants received recommended dose of [68Ga]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq]. |
| BG001 | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Treatment Emergent Adverse Events | Treatment-emergent adverse events (TEAEs) were collected from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent. The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed. | Full Analysis Set (FAS) | Posted | Count of Participants | Participants | dosing through 28 days post-dose |
|
Adverse events (AEs) were collected from informed consent signature through study completion, an average of 4 weeks.
Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
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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 | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase I) | All eligible participants received recommended dose of [68Ga]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq]. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ileus | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA (23.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 29, 2020 | Sep 10, 2020 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Feb 22, 2018 | Sep 10, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D011469 | Prostatic Diseases |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D052776 | Female Urogenital Diseases |
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Phase I: characterize PK and dosimetry Phase II: diagnostic potential in 2 groups
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| 68Ga-PSMA-R2 PET imaging acquired at Day 1 (20-30 min post-injection, 1 hour, 2 hours and 3-4 hours post-injection) |
| Phase I: Urinary Excretion of [68Ga]-PSMA-R2 | Urine samples were collected (up to 6 hours after dosing) for activity-based pharmacokinetics characterization. The apparent systemic clearance for the analyte in urine (Cl) was summarized with descriptive statistics. | 0 to 6 hours post-dose |
| Phase I: Half-life of 68Ga-PSMA-R2 in Blood | Serial blood samples were collected (up to 6 hours after dosing) for activity-based pharmacokinetics characterization. The half-life (T^1/2) for the analyte in blood was summarized with descriptive statistics. | 0 to 6 hours post-dose |
| Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | PET/CT scans were performed at approximately 20 to 30 min and at 1, 2, 3 to 4 hours postinjection. Time activity curves (TACs) for the various organs were produced as non-decay-corrected fraction of injected activity (mSv/MBq) per organ. Only descriptive analysis performed. | 68Ga-PSMA-R2 PET imaging acquired at Day 1 (20-30 min post-injection, 1 hour, 2 hours and 3-4 hours post-injection) |
| Phase I: Residence Times in Normal Organs | Residence times of radiation in normal organs were summarized with descriptive statistics. | 68Ga-PSMA-R2 PET imaging acquired at Day 1 |
| Phase I: Absorbed Dose of 68Ga-PSMA-R2 | Absorbed radiation dose of 68Ga-PSMA-R2 in target organs were summarized with descriptive statistics. | 68Ga-PSMA-R2 PET imaging acquired at Day 1 |
| Phase I: Whole-body Dose of 68Ga-PSMA-R2 | The whole-body dose of 68Ga-PSMA-R2 was summarized with descriptive statistics. | 68Ga-PSMA-R2 PET imaging acquired at Day 1 |
| Phase I: Effective Dose of 68Ga-PSMA-R2 | The effective dose of 68Ga-PSMA-R2 was summarized with descriptive statistics. | 68Ga-PSMA-R2 PET imaging acquired at Day 1 |
| Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans by Timepoint | Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The SUVmean and SUVmax (g/mL) of each lesion were calculated and reported by lesion location with summary statistics at all imaging time points. | 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection) |
| Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans by Timepoint | Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The lesion Tumor to Background Ratio (TBR) was defined as SUVmax(lesion) / SUVmean(gluteal or thigh) was calculated and reported by lesion location with summary statistics at all imaging time points. | 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection) |
| Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Also Detected by Conventional Scans by Timepoint | Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The SUVmean and SUVmax (g/mL) of each lesion were calculated and reported by lesion location with summary statistics at all imaging time points. | 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection) |
| Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans and Also Detected by Conventional Scans by Timepoint | Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The lesion Tumor to Background Ratio (TBR) was defined as SUVmax(lesion) / SUVmean(gluteal or thigh) was calculated and reported by lesion location with summary statistics at all imaging time points. | 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection) |
| Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint | Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The SUVmean and SUVmax (g/mL) of each lesion were calculated and reported by lesion location with summary statistics at all imaging time points. | 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection) |
| Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint | Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The lesion Tumor to Background Ratio (TBR) was defined as SUVmax(lesion) / SUVmean(gluteal or thigh) was calculated and reported by lesion location with summary statistics at all imaging time points. | 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection) |
| Patient Level Agreement of 68Ga-PSMA-R2 PET Imaging Relative to Conventional Techniques in Prostate Cancer Patients | The subject-level positive percent agreement, negative percent agreement, and overall percent agreement was calculated based on the number of subjects with at least 1 positive lesion detected by conventional scan or at least 1 positive lesion detected by PET scan. These percent agreements were calculated as follows:
Where:
| 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection) |
| Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | The differences of number of positive lesions, number of positive lesions detected by PET scan and/or conventional scan and the location of positive lesions were summarized with descriptive statistics. | 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour post-injection) |
| San Francisco |
| California |
| 94158 |
| United States |
| Smilow Cancer Center at Yale New Haven | New Haven | Connecticut | 06510 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| National Institutes of Health, Warren Grant Magnusen Clinical Center | Bethesda | Maryland | 20892 | United States |
All eligible participants received recommended dose of [68Ga]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq]. |
| BG002 | Metastatic Prostate Cancer (mPCa) (Phase II) | All eligible participants received recommended dose of [68Ga]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq]. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| ECOG Performance Status | The Eastern Cooperative Oncology Group Performance Status (ECOG PS) score classifies participants according to their functional impairment, with scores ranging from 0 (fully active) to 5 (dead). ECOG PS: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. | Count of Participants | Participants |
|
| Prostate-specific antigen (PSA) levels | Baseline is defined as the last measurement prior to Investigational Medicinal Product (IMP) administration. | Mean | Standard Deviation | ng/mL |
|
| Time since first prostate cancer diagnosis | Time since first prostate cancer diagnosis is defined as (date of screening - date of first prostate cancer diagnosis + 1) / 30.4375. | Mean | Standard Deviation | Months |
|
| Time since first metastasis | Time since first metastasis is defined as (date of screening - date of first metastasis + 1)/ 30.4375. | Mean | Standard Deviation | Months |
|
| Time since disease progression | Time since disease progression is defined as (date of screening - date of disease progression + 1)/ 30.4375. | Mean | Standard Deviation | Months |
|
| Number of patients by castration type | Count of Participants | Participants |
|
| Number of patients by Primary and Secondary Gleason score | The Gleason score is based on biopsy samples taken from the prostate. Both a primary and a secondary pattern of tissue organization are identified. The primary pattern represents the most common tissue pattern seen in the tumor, and the secondary pattern represents the next most common pattern. Each pattern is given a grade from 1 to 5, with 1 looking the most like normal prostate tissue and 5 looking the most abnormal. The two grades are then added to give a Gleason score. | Count of Participants | Participants |
|
| Number of patients by Total Gleason score (>=6) | Gleason score can range from 2-10. The higher the Gleason Score, the more likely that the cancer will grow and spread quickly. Scores of 6 (or less) describe cancer cells that look similar to normal cells and suggest that the cancer is likely to grow slowly. A score of 7 suggests an intermediate risk for aggressive cancer. Scores of 8 (or higher) describe cancers that are likely to spread more rapidly, these cancers are often referred to as poorly differentiated or high grade. | Count of Participants | Participants |
|
| Baseline Weight | Baseline is defined as the last measurement prior to Investigational Medicinal Product (IMP) administration. | Mean | Standard Deviation | kilogram (kg) |
|
| Baseline Height | Baseline is defined as the last measurement prior to Investigational Medicinal Product (IMP) administration. | Mean | Standard Deviation | centimeter (cm) |
|
| OG001 | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | All eligible participants received recommended dose of [68Ga]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq]. |
| OG002 | Metastatic Prostate Cancer (mPCa) (Phase II) | All eligible participants received recommended dose of [68Ga]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq]. |
|
|
| Secondary | Phase I: Decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | PET/CT scans were performed at approximately 20 to 30 min and at 1, 2, 3 to 4 hours postinjection. Time activity curves (TACs) for various organs (Brain, Heart Wall, Kidney, Lacrimal Gland, Liver, Lungs, Salivary Gland, Spleen and Thyroid) were produced as decay-corrected tissue of injected activity (mSv/MBq) per organ. Only descriptive analysis performed. | Full Analysis Set (FAS). Only participants with a value at each post-injection timepoints were included in the analysis. | Posted | Mean | Standard Deviation | mSv/MBq | 68Ga-PSMA-R2 PET imaging acquired at Day 1 (20-30 min post-injection, 1 hour, 2 hours and 3-4 hours post-injection) |
|
|
|
| Secondary | Phase I: Urinary Excretion of [68Ga]-PSMA-R2 | Urine samples were collected (up to 6 hours after dosing) for activity-based pharmacokinetics characterization. The apparent systemic clearance for the analyte in urine (Cl) was summarized with descriptive statistics. | Full Analysis Set (FAS). | Posted | Mean | Standard Deviation | mL/hr | 0 to 6 hours post-dose |
|
|
|
| Secondary | Phase I: Half-life of 68Ga-PSMA-R2 in Blood | Serial blood samples were collected (up to 6 hours after dosing) for activity-based pharmacokinetics characterization. The half-life (T^1/2) for the analyte in blood was summarized with descriptive statistics. | Full Analysis Set (FAS). | Posted | Mean | Standard Deviation | Hour | 0 to 6 hours post-dose |
|
|
|
| Secondary | Phase I: Non-decay Corrected Tissue Time-activity Curves (TACs) From 68Ga-PSMA-R2 PET/CT Images in Normal Organs | PET/CT scans were performed at approximately 20 to 30 min and at 1, 2, 3 to 4 hours postinjection. Time activity curves (TACs) for the various organs were produced as non-decay-corrected fraction of injected activity (mSv/MBq) per organ. Only descriptive analysis performed. | Full Analysis Set (FAS). Only participants with a value at each post-injection timepoints were included in the analysis. | Posted | Mean | Standard Deviation | mSv/MBq | 68Ga-PSMA-R2 PET imaging acquired at Day 1 (20-30 min post-injection, 1 hour, 2 hours and 3-4 hours post-injection) |
|
|
|
| Secondary | Phase I: Residence Times in Normal Organs | Residence times of radiation in normal organs were summarized with descriptive statistics. | Full Analysis Set (FAS). For each parameter, only participants with a value are included in the analysis. | Posted | Mean | Standard Deviation | MBq-hr/MBq | 68Ga-PSMA-R2 PET imaging acquired at Day 1 |
|
|
|
| Secondary | Phase I: Absorbed Dose of 68Ga-PSMA-R2 | Absorbed radiation dose of 68Ga-PSMA-R2 in target organs were summarized with descriptive statistics. | Full Analysis Set (FAS). | Posted | Mean | Standard Deviation | mGy/MBq | 68Ga-PSMA-R2 PET imaging acquired at Day 1 |
|
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|
| Secondary | Phase I: Whole-body Dose of 68Ga-PSMA-R2 | The whole-body dose of 68Ga-PSMA-R2 was summarized with descriptive statistics. | Full Analysis Set (FAS) | Posted | Mean | Standard Deviation | mGy/MBq | 68Ga-PSMA-R2 PET imaging acquired at Day 1 |
|
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|
| Secondary | Phase I: Effective Dose of 68Ga-PSMA-R2 | The effective dose of 68Ga-PSMA-R2 was summarized with descriptive statistics. | Full Analysis Set (FAS) | Posted | Mean | Standard Deviation | mSv/MBq | 68Ga-PSMA-R2 PET imaging acquired at Day 1 |
|
|
|
| Secondary | Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans by Timepoint | Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The SUVmean and SUVmax (g/mL) of each lesion were calculated and reported by lesion location with summary statistics at all imaging time points. | Full Analysis Set (FAS) | Posted | Mean | Standard Deviation | Standard Uptake Value (SUV) | 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection) |
|
|
|
| Secondary | Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans by Timepoint | Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The lesion Tumor to Background Ratio (TBR) was defined as SUVmax(lesion) / SUVmean(gluteal or thigh) was calculated and reported by lesion location with summary statistics at all imaging time points. | Full Analysis Set (FAS) | Posted | Mean | Standard Deviation | Ratio | 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection) |
|
|
|
| Secondary | Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Also Detected by Conventional Scans by Timepoint | Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The SUVmean and SUVmax (g/mL) of each lesion were calculated and reported by lesion location with summary statistics at all imaging time points. | Full Analysis Set (FAS). Only participants with at least 1 positive lesion detected by conventional scan and at least 1 positive lesion detected by PET included in the analysis. | Posted | Mean | Standard Deviation | Standard Uptake Value (SUV) | 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection) |
|
|
|
| Secondary | Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans and Also Detected by Conventional Scans by Timepoint | Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The lesion Tumor to Background Ratio (TBR) was defined as SUVmax(lesion) / SUVmean(gluteal or thigh) was calculated and reported by lesion location with summary statistics at all imaging time points. | Full Analysis Set (FAS). Only participants with at least 1 positive lesion detected by conventional scan and at least 1 positive lesion detected by PET included in the analysis. | Posted | Mean | Standard Deviation | Ratio | 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection) |
|
|
|
| Secondary | Standard Uptake Value (SUV) Mean and Max in Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint | Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The SUVmean and SUVmax (g/mL) of each lesion were calculated and reported by lesion location with summary statistics at all imaging time points. | Full Analysis Set (FAS) | Posted | Mean | Standard Deviation | Standard Uptake Value (SUV) | 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection) |
|
|
|
| Secondary | Tumor to Background Ratio (TBR) of Lesions Detected by PET Scans and Not Detected by Conventional Scans by Timepoint | Targeting properties of 68Ga-PSMA-R2 were evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET/CT imaging (4 scans). The lesion Tumor to Background Ratio (TBR) was defined as SUVmax(lesion) / SUVmean(gluteal or thigh) was calculated and reported by lesion location with summary statistics at all imaging time points. | Full Analysis Set (FAS) | Posted | Mean | Standard Deviation | Ratio | 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection) |
|
|
|
| Secondary | Patient Level Agreement of 68Ga-PSMA-R2 PET Imaging Relative to Conventional Techniques in Prostate Cancer Patients | The subject-level positive percent agreement, negative percent agreement, and overall percent agreement was calculated based on the number of subjects with at least 1 positive lesion detected by conventional scan or at least 1 positive lesion detected by PET scan. These percent agreements were calculated as follows:
Where:
| Full Analysis Set (FAS) | Posted | Number | 95% Confidence Interval | Percent Agreement | 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour, 2 hours post-injection) |
|
|
|
| Secondary | Burden of Tumor Lesions Measured by 68Ga-PSMA-R2 PET (1hr) Scan Compared With Standard Imaging Modality, by Location (Overall) | The differences of number of positive lesions, number of positive lesions detected by PET scan and/or conventional scan and the location of positive lesions were summarized with descriptive statistics. | Full Analysis Set (FAS) | Posted | Number | Positive Lesion | 68Ga-PSMA-R2 PET imaging acquired at Day 1 (1 hour post-injection) |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 1 |
| 6 |
| EG001 | Biochemically Recurrent Prostate Cancer (PCa-BR) (Phase II) | All eligible participants received recommended dose of [68Ga]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq]. | 0 | 12 | 1 | 12 | 4 | 12 |
| EG002 | Metastatic Prostate Cancer (mPCa) (Phase II) | All eligible participants received recommended dose of [68Ga]-PSMA-R2 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq]. | 0 | 12 | 0 | 12 | 2 | 12 |
| Influenza like illness | General disorders | MedDRA (23.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (23.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Brain@2 hours post-injection |
|
|
| Brain@3-4 hours post-injection |
|
|
| Heart Wall@20-30 minutes post-injection |
|
|
| Heart Wall@1 hour post-injection |
|
|
| Heart Wall@2 hours post-injection |
|
|
| Heart Wall@3-4 hours post-injection |
|
|
| Kidney@20-30 minutes post-injection |
|
|
| Kidney@1 hour post-injection |
|
|
| Kidney@2 hours post-injection |
|
|
| Kidney@3-4 hours post-injection |
|
|
| Lacrimal Gland@20-30 minutes post-injection |
|
|
| Lacrimal Gland@1 hour post-injection |
|
|
| Lacrimal Gland@2 hours post-injection |
|
|
| Lacrimal Gland@3-4 hours post-injection |
|
|
| Liver@20-30 minutes post-injection |
|
|
| Liver@1 hour post-injection |
|
|
| Liver@2 hours post-injection |
|
|
| Liver@3-4 hours post-injection |
|
|
| Lungs@20-30 minutes post-injection |
|
|
| Lungs@1 hour post-injection |
|
|
| Lungs@2 hours post-injection |
|
|
| Lungs@3-4 hours post-injection |
|
|
| Salivary Gland@20-30 minutes post-injection |
|
|
| Salivary Gland@1 hour post-injection |
|
|
| Salivary Gland@2 hours post-injection |
|
|
| Salivary Gland@3-4 hours post-injection |
|
|
| Spleen@20-30 minutes post-injection |
|
|
| Spleen@1 hour post-injection |
|
|
| Spleen@2 hours post-injection |
|
|
| Spleen@3-4 hours post-injection |
|
|
| Thyroid@20-30 minutes post-injection |
|
|
| Thyroid@1 hour post-injection |
|
|
| Thyroid@2 hours post-injection |
|
|
| Thyroid@3-4 hours post-injection |
|
|
|
| Brain@2 hours post-injection |
|
|
| Brain@3-4 hours post-injection |
|
|
| Heart Wall@20-30 minutes post-injection |
|
|
| Heart Wall@1 hour post-injection |
|
|
| Heart Wall@2 hours post-injection |
|
|
| Heart Wall@3-4 hours post-injection |
|
|
| Kidney@20-30 minutes post-injection |
|
|
| Kidney@1 hour post-injection |
|
|
| Kidney@2 hours post-injection |
|
|
| Kidney@3-4 hours post-injection |
|
|
| Lacrimal Gland@20-30 minutes post-injection |
|
|
| Lacrimal Gland@1 hour post-injection |
|
|
| Lacrimal Gland@2 hours post-injection |
|
|
| Lacrimal Gland@3-4 hours post-injection |
|
|
| Liver@20-30 minutes post-injection |
|
|
| Liver@1 hour post-injection |
|
|
| Liver@2 hours post-injection |
|
|
| Liver@3-4 hours post-injection |
|
|
| Lungs@20-30 minutes post-injection |
|
|
| Lungs@1 hour post-injection |
|
|
| Lungs@2 hours post-injection |
|
|
| Lungs@3-4 hours post-injection |
|
|
| Salivary Gland@20-30 minutes post-injection |
|
|
| Salivary Gland@1 hour post-injection |
|
|
| Salivary Gland@2 hours post-injection |
|
|
| Salivary Gland@3-4 hours post-injection |
|
|
| Spleen@20-30 minutes post-injection |
|
|
| Spleen@1 hour post-injection |
|
|
| Spleen@2 hours post-injection |
|
|
| Spleen@3-4 hours post-injection |
|
|
| Thyroid@20-30 minutes post-injection |
|
|
| Thyroid@1 hour post-injection |
|
|
| Thyroid@2 hours post-injection |
|
|
| Thyroid@3-4 hours post-injection |
|
|
|
| Kidney |
|
|
| Lacrimal Gland |
|
|
| Liver |
|
|
| Lungs |
|
|
| Salivary Gland |
|
|
| Spleen |
|
|
| Thyroid |
|
|
| Urinary Bladder |
|
|
| Remainder |
|
|
| Title | Measurements |
|---|---|
|
| Lacrimal Gland |
|
| Liver |
|
| Lungs |
|
| Red Marrow |
|
| Salivary Gland |
|
| Spleen |
|
| Urinary Bladder |
|
|
| PET (2hr): SUVmax (lesion) |
|
| PET (2hr): SUVmean (background) |
|
|
| PET (1hr): SUVmean (background) |
|
|
| PET (2hr): SUVmax (lesion) |
|
|
| PET (2hr): SUVmean (background) |
|
|
| PET (2hr): TBR |
|
|
|
| PET (2hr): SUVmax (lesion) |
|
| PET (2hr): SUVmean (background) |
|
|
| PET(1hr): Negative percent agreement |
|
| PET(1hr): Overall percent agreement |
|
| PET(2hr): Positive percent agreement |
|
| PET(2hr): Negative percent agreement |
|
| PET(2hr): Overall percent agreement |
|
| Title | Measurements |
|---|---|
|
| PET(+) and detected by conventional scan |
|
| PET+/detected by CT:Bone,Cervical Spine |
|
| PET+/detected by CT:Bone,Lumbar Spine |
|
| PET+/detected by CT:Bone,Thoracic Spine |
|
| PET+/detected by CT:Pelvic Bone |
|
| PET+/detected by CT:Pelvis |
|
| PET+/detected by CT:Rib(s),L. |
|
| PET+/detected by CT:Rib(s),R. |
|
| PET(+) and not detected by conventional scan |
|
| PET+/undetected by CT:Abdominal Wall |
|
| PET+/undetected by CT:Bone,Lumbar Spine |
|
| PET+/undetected by CT:Bone,Other |
|
| PET+/undetected by CT:Bone,Thoracic Spine |
|
| PET+/undetected by CT:Lymph Node,Common Iliac |
|
| PET+/undetected by CT:Lymph Node,External |
|
| PET+/undetected by CT:Lymph Node,Inguinal,L. |
|
| PET+/undetected by CT:Lymph Node,Inguinal,R. |
|
| PET+/undetected by CT:Lymph Node,Para-Aortic |
|
| PET+/undetected by CT:Lymph Node,Retrocrural |
|
| PET+/undetected by CT:Lymph Node,Retroperitoneal |
|
| PET+/undetected by CT:Lymph Node,Supraclavicular,L |
|
| PET+/undetected by CT:Other,Extranodal |
|
| PET+/undetected by CT:Other,Nodal |
|
| PET+/undetected by CT:Pelvic Bone |
|
| PET+/undetected by CT:Rib(s),L. |
|
| PET+/undetected by CT:Rib(s),R. |
|
| PET+/undetected by CT:Urethra |
|
| Conventional (+) and not detected by PET scan |
|
| CT+/undetected by PET:Bone,Lumbar Spine |
|
| CT+/undetected by PET:Bone,Other |
|
| CT+/undetected by PET:Bone,Thoracic Spine |
|
| CT+/undetected by PET:Lymph Node,Pelvic |
|
| CT+/undetected by PET:Pelvic Bone |
|
| CT+/undetected by PET:Rib(s),L. |
|
| CT+/undetected by PET:Rib(s),R. |
|
| CT+/undetected by PET:Skull |
|