Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study was to evaluate the impact of concurrent versus sequential administration of abiraterone acetate plus prednisone on the ability to manufacture sipuleucel-T (by assessing sipuleucel-T product parameters), and to assess the safety and efficacy of sipuleucel-T with concurrent or sequential administration of abiraterone acetate plus prednisone in men with metastatic castrate resistant prostate cancer.
Subjects underwent screening procedures at the Screening Visit to ensure that they met the inclusion and exclusion criteria outlined in the protocol. Subjects were evaluated for eligibility criteria, and if eligible, were registered and randomized in a 1:1 into either the Concurrent Arm or the Sequential Arm.
Subjects in both arms underwent a standard 1.5 to 2.0 blood volume leukapheresis, followed approximately 3 days later by an intravenous (IV) infusion of sipuleucel-T. This process occurred at approximately 2-week intervals. A course of sipuleucel-T treatment comprised three infusions.
Following the first infusion, subjects were limited to a maximum of three total product failures for all subsequent infusions, due specifically to insufficient total nucleated cell (TNC) count and/or CD54 upregulation. These subjects received no further leukaphereses or sipuleucel-T infusions, but did receive abiraterone acetate plus prednisone per the schedule of the arm to which they were randomized. All subjects received a total of 26 weeks of abiraterone acetate plus prednisone therapy.
All immune monitoring (IM) endpoints were collected from all subjects who received at least one infusion. Cellular and serological immune responses were assessed for subjects in both arms. In both arms, IM blood samples were collected at baseline (screening); pre-leukapheresis 2 and 3; post-infusion 1, 2, and 3; and weeks 6, 10, 14, and 26, with the timing of IM visits based on the onset of treatment (Day 0). Day 0 was the day of the first infusion. Post-infusion blood draws occurred at 3 hours (allowable window 1-24 hours) after each infusion. If a subject received only one or two infusions, immune samples were still drawn at the scheduled time points based on the first infusion (Day 0). If the subject was not scheduled to undergo further leukapheresis, no other pre-leukapheresis procedures were conducted.
During the active follow-up phase, subjects were followed from registration through the Post-Treatment Visit (30-37 days post-last study treatment), or until disease progression, unacceptable toxicity, or death, whichever occurred first.
During the long-term follow-up (LTFU) phase, subjects were followed from the Post-Treatment Visit for up to 3 years from the date of registration/randomization. During the LTFU phase, only new treatment-related serious adverse event (SAE)s, cerebrovascular event (CVE)s (regardless of causality), the first anti-cancer therapy and first chemotherapy, and survival status were collected via a quarterly telephone call.
Overall survival was measured as the time from randomization until death over a 3-year period.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concurrent Arm | Experimental | Subjects received sipuleucel-T concurrent with abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone treatment started the next day after the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death, occurred. |
|
| Sequential Arm | Experimental | Subjects received sipuleucel-T therapy followed by abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone started at week 10 from the start of the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death, occurred. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sipuleucel-T | Biological | Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF). |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative CD54 Upregulation Ratio Between the Cohorts. | An analysis of variance model for the log transformed cumulative CD54 upregulation ratio (CD54 upregulation is the fold increase in the final product (FP) from buoyant density separations (BDS) step 65. BDS65 step refers to sample taken after both BDS77 and BDS65 but before ex vivo culture in the presence of antigen PA2024. FP refers to sample taken after ex vivo culture) that includes the antigen concentration cohort as the independent variable was performed. Subjects who received all 3 infusions were included. | Over the course of sipuleucel-T therapy (approximately 1 month) |
Not provided
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert Israel, MD | Valeant Pharmaceuticals North America LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Medical Center - La Jolla | La Jolla | California | 92037 | United States | ||
| Moores UCSD Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37058234 | Derived | Antonarakis ES, Subudhi SK, Pieczonka CM, Karsh LI, Quinn DI, Hafron JM, Wilfehrt HM, Harmon M, Sheikh NA, Shore ND, Petrylak DP. Combination Treatment with Sipuleucel-T and Abiraterone Acetate or Enzalutamide for Metastatic Castration-Resistant Prostate Cancer: STAMP and STRIDE Trials. Clin Cancer Res. 2023 Jul 5;29(13):2426-2434. doi: 10.1158/1078-0432.CCR-22-3832. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Concurrent Arm | Subjects received sipuleucel-T with concurrent abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone treatment started the next day after the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death occurred. sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF). abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| abiraterone acetate | Drug | Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks. |
|
|
| La Jolla |
| California |
| 92093 |
| United States |
| Cancer Center Oncology Medical Group | La Mesa | California | 91942 | United States |
| UCSD Medical Center - Hillcrest | San Diego | California | 92103 | United States |
| Medical Oncology Associates - SD | San Diego | California | 92123 | United States |
| Sharp Rees-Stealy | San Diego | California | 92123 | United States |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94115 | United States |
| The Urology Center of Colorado | Denver | Colorado | 80211 | United States |
| Georgetown University Medical Center - Lombardi Cancer Center | Washington D.C. | District of Columbia | 20007 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Mid Atlantic Urology Associates, Mid Atlantic Clinical Research | Greenbelt | Maryland | 20770 | United States |
| GU Research Center, LLC | Omaha | Nebraska | 68130 | United States |
| NYU Clinical Cancer Center, NYU Langone Medical Center | New York | New York | 10016 | United States |
| The Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Associated Medical Professionals of NY, PLLC | Oneida | New York | 13421 | United States |
| Associated Medical Professionals of New York, PLLC | Syracuse | New York | 13210 | United States |
| Providence Cancer Center Oncology and Hematology Care | Portland | Oregon | 97213 | United States |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | United States |
| Urology Associates, P.C. | Nashville | Tennessee | 37209 | United States |
| Urology of Virginia | Virginia Beach | Virginia | 23462 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| FG001 | Sequential Arm | Subjects received sipuleucel-T therapy followed by abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone started at week 10 from the start of the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death occurred. sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF). abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks. |
| Subjects Randomized (Efficacy Analysis) |
|
| Rcvd ≥1 Leukapheresis (Safety Analysis) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Concurrent Arm | Subjects received sipuleucel-T concurrent with abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone treatment started the next day after the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death, occurred. sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF). abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks. |
| BG001 | Sequential Arm | Subjects received sipuleucel-T therapy followed by abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone started at week 10 from the start of the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death, occurred. sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF). abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Weight | Mean | Standard Deviation | Kg |
| |||||||||||||||||
| Height | Mean | Standard Deviation | Centimeters |
| |||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status | ECOG Performance Status is a method used to assess the functional status of a patient. The scale ranges from 0-5. 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 light or sedentary work; 2=Ambulatory, capable of all self-care but unable to carry out work activities. Up and about >50% of waking hour; 3=Capable of limited self-care, confined to bed or chair >50% of waking hours; 4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5=Dead | Count of Participants | Participants |
| |||||||||||||||||
| Gleason Score | Gleason score= prostate cancer grading system based on how tissue looks under a microscope. Scores range 2-10 and indicates how likely it is that a tumor will spread. A low score means the cancer tissue is similar to normal tissue and the tumor is less likely to spread. Gleason Score ≤ 6=the tumor is well differentiated, less aggressive and likely to grow more slowly;7=the tumor is moderately differentiated, moderately aggressive, and likely to grow but may not spread quickly;≥8=the tumor is poorly differentiated or undifferentiated, highly aggressive, and likely to grow faster and spread. | Count of Participants | 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 | Cumulative CD54 Upregulation Ratio Between the Cohorts. | An analysis of variance model for the log transformed cumulative CD54 upregulation ratio (CD54 upregulation is the fold increase in the final product (FP) from buoyant density separations (BDS) step 65. BDS65 step refers to sample taken after both BDS77 and BDS65 but before ex vivo culture in the presence of antigen PA2024. FP refers to sample taken after ex vivo culture) that includes the antigen concentration cohort as the independent variable was performed. Subjects who received all 3 infusions were included. | The efficacy population is defined as all randomized subjects. All the subjects in the efficacy population were analyzed according to the treatment that they were randomized to receive. | Posted | Mean | Standard Error | Ratio ofCD54 molecules on BDS65:FP cells | Over the course of sipuleucel-T therapy (approximately 1 month) |
|
|
|
|
All adverse events (AEs) and serious adverse events (SAEs) were recorded from registration until the Post-Treatment Visit (30-37 days after last study treatment). Only treatment-related AEs and cerebrovascular events (CVEs) ongoing at the Post-Treatment Visit, were followed until resolution, return to baseline or no further improvement was expected. After the Post-Treatment Visit, only new treatment-related SAEs and CVEs (regardless of causality) were collected and recorded as SAEs.
Not provided
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 | Concurrent Arm | Subjects received sipuleucel-T concurrent with abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone treatment started the next day after the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death occurred. sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF). abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks. | 19 | 35 | 7 | 35 | 35 | 35 |
| EG001 | Sequential Arm | Subjects received sipuleucel-T therapy followed by abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone started at week 10 from the start of the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death occurred. sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF). abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks. | 19 | 34 | 14 | 34 | 32 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Disease Progression | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Systemic Inflammatory Response Syndrome | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Subdural Haematoma | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Muscle Haemorrhage | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pathological Fracture | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Haemorrhage Intracranial | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Obstructive Uropathy | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Ureteric Obstruction | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypertensive Crisis | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Paraesthesia Oral | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Oedema Periperal | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Gait Disturbance | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Oral Herpes | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Citrate Toxicity | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Blood Urea Increased | Investigations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Heart Rate Irregular | Investigations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Gynaecomastia | Reproductive system and breast disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pleuritic Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hot Flush | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
|
The results of the Study will be published and/or presented in an integrated manner reflecting the results observed across all participating centers. Accordingly, decisions on timing and content of publications and presentations relating to the Study will be coordinated by Dendreon in communication with institutions contributing patients to the Study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shabnam Vaziri | Dendreon | 206-455-2323 | svaziri@Dendreon.com |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C511774 | sipuleucel-T |
| D000069501 | Abiraterone Acetate |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| ECOG 1= Restricted Strenuous Activity |
|
| Gleason Score = 7 |
|
| Gleason Score ≥ 8 |
|
| Gleason Score - Missing Data |
|