Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 133661 | Other Identifier | Original sponsor |
Not provided
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Recruitment was stopped before the target sample size was achieved.
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This was an open-label, multicenter, prospective trial to assess safety and efficacy of 177Lu-PSMA-617 in patients with metastatic castration resistant prostate cancer.
Upon inclusion patients were randomized in a 1:1 ratio into two treatment doses. Radioligand therapy (RLT) were performed by repeated intravenous (i.v.) injection of 6.0 gigabecquerel (GBq) (+/- 10%) or 7.4 GBq (+/- 10%) 177Lu-PSMA-617 every 8+/- 1 weeks until reaching four cycles or threshold maximum dose to the kidneys of 23 Gray (Gy). All doses after labeling were presented in buffered solution for i.v. injection.
In the initial plan for the study design a total of 200 patients with histologically proven prostate cancer and metastatic castration-resistant prostate cancer (mCRPC) were to be enrolled, however due to early stopping of enrollment only 71 patients were enrolled at time of data base lock. Each patient underwent a screening visit within 14 days prior to receiving study drug. Treatment was continued until either of the following conditions applied:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 177Lu-PSMA-617 (6.0 GBq) | Experimental | Repeated i.v. application of 6.0 GBq (gigabequerel)(+/- 10%, arm 1) every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry |
|
| 177Lu-PSMA-617 (7.4 GBq) | Experimental | Repeated i.v. application of 7.4 GBq (gigabequerel)(+/- 10%, arm 2) of drug every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 177Lu-PSMA-617 | Drug | Lutetium (177Lu) -DOTA (1,4,7,10-tetra-azacyclododecane-N,N',N'',N'''-tetraacetic acid )-PSMA has three components: PSMA is the targeting vector , DOTA (1, 4, 7, 10-tetraazacyclododecane-1, 4, 7, 10-tetraacetic acid) is a radiometal chelator and a linking group, and 177Lu is the beta emitter that upon internalization delivers radiation to the nucleus of tumor cells to cause DNA damage. The targeting vector utilizes glu-urea-lys sequence which is an inhibitor capable of binding to the domain of PSMA. These components have been previously used in human subjects and in medical research. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events | Treatment-emergent adverse events (TEAEs) were collected from first dosing 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. | From first dosing (Day 0) 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, up to 24 months |
| Number of Participants Achieving PSA Response at Week 12 | PSA response was defined as the proportion of patients who had a >= 50% decrease in PSA from Baseline at Week 12. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in PSA From Baseline to Week 12 | Percent change in PSA from Baseline to Week 12 was reported for participants who had a baseline and a week 12 valid assessments. | Week 12 |
| Maximum Percent Change in PSA Response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| David Geffen School of Medicine at UCLA | Los Angeles | California | 90095 | United States | ||
| Excel Diagnostics and Nuclear Oncology Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34246328 | Derived | Gafita A, Calais J, Grogan TR, Hadaschik B, Wang H, Weber M, Sandhu S, Kratochwil C, Esfandiari R, Tauber R, Zeldin A, Rathke H, Armstrong WR, Robertson A, Thin P, D'Alessandria C, Rettig MB, Delpassand ES, Haberkorn U, Elashoff D, Herrmann K, Czernin J, Hofman MS, Fendler WP, Eiber M. Nomograms to predict outcomes after 177Lu-PSMA therapy in men with metastatic castration-resistant prostate cancer: an international, multicentre, retrospective study. Lancet Oncol. 2021 Aug;22(8):1115-1125. doi: 10.1016/S1470-2045(21)00274-6. Epub 2021 Jul 8. |
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This study was conducted at 2 centers in the USA
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| ID | Title | Description |
|---|---|---|
| FG000 | 177Lu-PSMA-617 (6.0 GBq) | Repeated i.v. application of 6.0 GBq (gigabequerel)(+/- 10%, arm 1) every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry |
| FG001 | 177Lu-PSMA-617 (7.4 GBq) | Repeated i.v. application of 7.4 GBq (gigabequerel)(+/- 10%, arm 2) of drug every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 177Lu-PSMA-617 (6.0 GBq) | Repeated i.v. application of 6.0 GBq (gigabequerel)(+/- 10%, arm 1) every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry |
| BG001 | 177Lu-PSMA-617 (7.4 GBq) |
| 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 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. | Safety Population | Posted | Count of Participants | Participants | From first dosing (Day 0) 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, up to 24 months |
|
Adverse events (AEs) were collected from informed consent signature through to 24 months after first 177Lu-PSMA-617 treatment therapy.
Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (Day 0) 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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 177Lu-PSMA-617 (6.0 GBq) | Repeated i.v. application of 6.0 GBq (gigabequerel)(+/- 10%, arm 1) every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (22.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (22.1) | Systematic Assessment |
The study began on 05-Jul-17 as an Investigator Initiated Trial and sponsorship was transferred to Endocyte on 01-Jun-18. Recruitment was stopped before the target sample size was achieved based on strategic considerations.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 1, 2018 | Jan 14, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 15, 2020 | Jan 14, 2021 | SAP_001.pdf |
Not provided
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| ID | Term |
|---|---|
| C000610110 | Pluvicto |
Not provided
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|
|
Maximal baseline to follow-up PSA decline, at any time during or after therapy was evaluated in both treatment groups.
| Every 6 weeks during the treatment and every 3 (+/- 1) months after last treatment until reaching endpoint or 24 months after the first treatment |
| PSA Progression and Death Events | PSA progression was defined as:
| Date of randomization to the date of first documented PSA progression or death, whichever occurs first, reported between day of first patient randomized up to 24 months after the first treatment |
| RECIST 1.1 Overall Response by Follow-up Assessment Visit | For each follow-up imaging assessment by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) for target, non-target, and new lesions assessed by CT or MRI: the number of participants with an overall response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD). The timing of follow-up imaging assessments varied depending on how many RLT cycles a participant received. Therefore, regardless of when the imaging assessments occurred, each participant's first follow-up imaging was combined as Follow-up 1, each participant's second follow-up imaging was combined as Follow-up 2, each participant's third follow-up imaging was combined as Follow-up 3, and each participant's fourth follow-up imaging was combined as Follow-up 4. | Before 3rd radioligand therapy (RLT) cycle, and then every 3 (+/- 1) months after last treatment dose until disease progression or 24 months after the first treatment dose. |
| RECIST 1.1 Disease Control Rate by Follow-up Assessment Visit | The proportion of participants with an overall response of Complete Response (CR), Partial Response (PR) and Stable Disease (SD) was reported using investigator assessments per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) for target, non-target, and new lesions assessed by CT or MRI. The timing of follow-up imaging assessments varied depending on how many RLT cycles a participant received. Therefore, regardless of when the imaging assessments occurred, each participant's first follow-up imaging was combined as Follow-up 1, each participant's second follow-up imaging was combined as Follow-up 2, each participant's third follow-up imaging was combined as Follow-up 3, and each participant's fourth follow-up imaging was combined as Follow-up 4. | Before 3rd radioligand therapy (RLT) cycle, and then every 3 (+/- 1) months after last treatment dose until disease progression or 24 months after the first treatment dose. |
| Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Investigator's assessed bone metastases using the Prostate Cancer Working Group 3 (PCWG3) criteria; new lesions had to be confirmed on a second scan (2+2 rule). The investigator documented their clinical impression of each PCWG3 assessment as Improved, Stable or Progression. The number of participants with a clinical impression of Improved, Stable or Progression according to PCWG3 using investigators assessments was reported by visit. | Screening, Week 8, Week 10, Week 16, Week 18, Week 22, Week 24, Follow-up Week 4, Follow-up Week 6, Follow-up Week 8 |
| Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | The Expanded Prostate Cancer Index-Composite (EPIC) is a well-established patient-reported outcome (PRO) questionnaire developed to monitor health-related quality of life outcomes among prostate cancer. The 26-item version of EPIC, also known as EPIC Short Form or EPIC-26, contains 26 items and 5 domains: Urinary Incontinence (Items 1-4), Urinary Irritative/Obstructive (Items 5-8), Bowel (Items 10-15), Sexual (Items 16-21), and Hormonal (Items 22-26). Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0 to 100 scale for each domain, with higher scores representing better health-related quality of life. | Baseline, Month 3, Month 6, Follow-up Month 3 |
| Change From Baseline in Eastern Cooperative Oncology Group (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 housework, office work; 2 = ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours; 3 = capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = completely disabled, cannot carry on any self-care, totally confined to bed or chair; 5 = dead. | Baseline, Treatment Visit 1, Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Follow-up Month 3, Follow-up Month 12, Follow-up Month 15 |
| Houston |
| Texas |
| 77042 |
| United States |
| Lost to Follow-up |
|
| Any occurrence of conditions which prevented the patient's participation in the study. |
|
| Withdrawal by Subject |
|
Repeated i.v. application of 7.4 GBq (gigabequerel)(+/- 10%, arm 2) of drug every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
Repeated i.v. application of 6.0 GBq (gigabequerel)(+/- 10%, arm 1) every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry |
| OG001 | 177Lu-PSMA-617 (7.4 GBq) | Repeated i.v. application of 7.4 GBq (gigabequerel)(+/- 10%, arm 2) of drug every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry |
|
|
| Primary | Number of Participants Achieving PSA Response at Week 12 | PSA response was defined as the proportion of patients who had a >= 50% decrease in PSA from Baseline at Week 12. | ITT Population. Only participants with a value at both baseline and post baseline were included in the analysis. | Posted | Count of Participants | Participants | Week 12 |
|
|
|
| Secondary | Percent Change in PSA From Baseline to Week 12 | Percent change in PSA from Baseline to Week 12 was reported for participants who had a baseline and a week 12 valid assessments. | ITT Population. Only participants with a value at both baseline and post baseline were included in the analysis. | Posted | Mean | Standard Deviation | Percent change in PSA | Week 12 |
|
|
|
| Secondary | Maximum Percent Change in PSA Response | Maximal baseline to follow-up PSA decline, at any time during or after therapy was evaluated in both treatment groups. | ITT Population. Only participants with a value at both baseline and post baseline were included in the analysis. | Posted | Mean | Standard Deviation | PSA percent change | Every 6 weeks during the treatment and every 3 (+/- 1) months after last treatment until reaching endpoint or 24 months after the first treatment |
|
|
|
| Secondary | PSA Progression and Death Events | PSA progression was defined as:
| ITT Population. Only participants with a value at both baseline and post baseline were included in the analysis | Posted | Count of Participants | Participants | Date of randomization to the date of first documented PSA progression or death, whichever occurs first, reported between day of first patient randomized up to 24 months after the first treatment |
|
|
|
| Secondary | RECIST 1.1 Overall Response by Follow-up Assessment Visit | For each follow-up imaging assessment by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) for target, non-target, and new lesions assessed by CT or MRI: the number of participants with an overall response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD). The timing of follow-up imaging assessments varied depending on how many RLT cycles a participant received. Therefore, regardless of when the imaging assessments occurred, each participant's first follow-up imaging was combined as Follow-up 1, each participant's second follow-up imaging was combined as Follow-up 2, each participant's third follow-up imaging was combined as Follow-up 3, and each participant's fourth follow-up imaging was combined as Follow-up 4. | ITT Population. Only participants with a value at both baseline and post baseline were included in the analysis | Posted | Count of Participants | Participants | Before 3rd radioligand therapy (RLT) cycle, and then every 3 (+/- 1) months after last treatment dose until disease progression or 24 months after the first treatment dose. |
|
|
|
| Secondary | RECIST 1.1 Disease Control Rate by Follow-up Assessment Visit | The proportion of participants with an overall response of Complete Response (CR), Partial Response (PR) and Stable Disease (SD) was reported using investigator assessments per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) for target, non-target, and new lesions assessed by CT or MRI. The timing of follow-up imaging assessments varied depending on how many RLT cycles a participant received. Therefore, regardless of when the imaging assessments occurred, each participant's first follow-up imaging was combined as Follow-up 1, each participant's second follow-up imaging was combined as Follow-up 2, each participant's third follow-up imaging was combined as Follow-up 3, and each participant's fourth follow-up imaging was combined as Follow-up 4. | ITT Population. Only participants with a value at both baseline and post baseline were included in the analysis | Posted | Number | Percentage of participants | Before 3rd radioligand therapy (RLT) cycle, and then every 3 (+/- 1) months after last treatment dose until disease progression or 24 months after the first treatment dose. |
|
|
|
| Secondary | Prostate Cancer Working Group 3 (PCWG3) Bone Scan Clinical Impression by Visit | Investigator's assessed bone metastases using the Prostate Cancer Working Group 3 (PCWG3) criteria; new lesions had to be confirmed on a second scan (2+2 rule). The investigator documented their clinical impression of each PCWG3 assessment as Improved, Stable or Progression. The number of participants with a clinical impression of Improved, Stable or Progression according to PCWG3 using investigators assessments was reported by visit. | ITT Population. Only participants with a value at both baseline and post baseline were included in the analysis | Posted | Count of Participants | Participants | Screening, Week 8, Week 10, Week 16, Week 18, Week 22, Week 24, Follow-up Week 4, Follow-up Week 6, Follow-up Week 8 |
|
|
|
| Secondary | Change From Baseline in Expanded Prostate Cancer Index Composite Short Form (EPIC-26) | The Expanded Prostate Cancer Index-Composite (EPIC) is a well-established patient-reported outcome (PRO) questionnaire developed to monitor health-related quality of life outcomes among prostate cancer. The 26-item version of EPIC, also known as EPIC Short Form or EPIC-26, contains 26 items and 5 domains: Urinary Incontinence (Items 1-4), Urinary Irritative/Obstructive (Items 5-8), Bowel (Items 10-15), Sexual (Items 16-21), and Hormonal (Items 22-26). Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0 to 100 scale for each domain, with higher scores representing better health-related quality of life. | ITT Population. For each domain, only participants with a value at both baseline and post baseline were included in the analysis. | Posted | Mean | Standard Deviation | Unit on a scale | Baseline, Month 3, Month 6, Follow-up Month 3 |
|
|
|
| Secondary | Change From Baseline in Eastern Cooperative Oncology Group (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 housework, office work; 2 = ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours; 3 = capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = completely disabled, cannot carry on any self-care, totally confined to bed or chair; 5 = dead. | ITT Population. Only participants with a value at both baseline and post baseline were included in the analysis. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Treatment Visit 1, Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Follow-up Month 3, Follow-up Month 12, Follow-up Month 15 |
|
|
|
| 3 |
| 23 |
| 4 |
| 23 |
| 22 |
| 23 |
| EG001 | 177Lu-PSMA-617 (7.4 GBq) | Repeated i.v. application of 7.4 GBq (gigabequerel)(+/- 10%, arm 2) of drug every 8+/- 1 weeks; RLT until reaching four cycles or threshold maximum dose to the kidneys of 23 Gy as determined by dosimetry | 3 | 41 | 8 | 41 | 38 | 41 |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (22.1) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
|
| Death | General disorders | MedDRA (22.1) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
|
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
|
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA (22.1) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (22.1) | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (22.1) | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (22.1) | Systematic Assessment |
|
| Deafness | Ear and labyrinth disorders | MedDRA (22.1) | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA (22.1) | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA (22.1) | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA (22.1) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
|
| Frequent bowel movements | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
|
| Hyperaesthesia teeth | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
|
| Lip dry | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
|
| Saliva altered | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (22.1) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (22.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (22.1) | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA (22.1) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (22.1) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (22.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (22.1) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA (22.1) | Systematic Assessment |
|
| Glomerular filtration rate decreased | Investigations | MedDRA (22.1) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (22.1) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
|
| Parosmia | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
|
| Taste disorder | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (22.1) | Systematic Assessment |
|
| Bladder pain | Renal and urinary disorders | MedDRA (22.1) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (22.1) | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA (22.1) | Systematic Assessment |
|
| Prostatic pain | Reproductive system and breast disorders | MedDRA (22.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA (22.1) | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA (22.1) | 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.
| PSA Response (Increase from Baseline) |
|
| Partial Response |
|
| Stable Disease |
|
| Progressive Disease |
|
| Follow-up 2 |
|
|
| Follow-up 3 |
|
|
| Follow-up 4 |
|
|
| Follow-up 2 |
|
|
| Follow-up 3 |
|
|
| Follow-up 4 |
|
|
| Stable |
|
| Progression |
|
| Week 8 |
|
|
| Week 10 |
|
|
| Week 16 |
|
|
| Week 18 |
|
|
| Week 22 |
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|
| Week 24 |
|
|
| Follow-up Week 4 |
|
|
| Follow-up Week 6 |
|
|
| Follow-up Week 8 |
|
|
| Urinary Incontinence (Change from BL@Month 3) |
|
|
| Urinary Incontinence (Change from BL@Month 6) |
|
|
| Urinary Incontinence (Change from BL@Follow-up Month 3) |
|
|
| Urinary Irritative/Obstructive (Baseline) |
|
|
| Urinary Irritative/Obstructive (Change from BL@Month 3) |
|
|
| Urinary Irritative/Obstructive (Change from BL@Month 6) |
|
|
| Urinary Irritative/Obstructive (Change from BL@Follow-up Month 3) |
|
|
| Bowel (Baseline) |
|
|
| Bowel (Change from BL@Month 3) |
|
|
| Bowel (Change from BL@Month 6) |
|
|
| Bowel (Change from BL@Follow-up Month 3) |
|
|
| Sexual (Baseline) |
|
|
| Sexual (Change from BL@Month 3) |
|
|
| Sexual (Change from BL@Month 6) |
|
|
| Sexual (Change from BL@Follow-up Month 3) |
|
|
| Hormonal (Baseline) |
|
|
| Hormonal (Change from BL@Month 3) |
|
|
| Hormonal (Change from BL@Month 6) |
|
|
| Hormonal (Change from BL@Follow-up Month 3) |
|
|
| Change from BL@Treatment Visit 1 |
|
|
| Change from BL@Treatment Visit 2 |
|
|
| Change from BL@Treatment Visit 3 |
|
|
| Change from BL@Treatment Visit 4 |
|
|
| Change from BL@Follow-up Month 3 |
|
|
| Change from BL@Follow-up Month 12 |
|
|
| Change from BL@Follow-up Month 15 |
|
|