An observational study in Advanced Prostate Cancer and Prostatic Neoplasms, sponsored by Dendreon. Completed at 333 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-07.
Sponsored by Dendreon · Observational
The purpose of this study is to further quantify the risk of cerebrovascular events (CVEs) following sipuleucel-T (PROVENGE®) therapy, and to follow all subjects for survival.
Subjects will receive product as described in the sipuleucel-T approved label. The registry will be strictly observational and thus no additional clinical visits or laboratory tests will be conducted beyond normal clinical practice. Investigators will be asked to record information that becomes available in the normal course of clinical management.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 1,976 is above the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Dendreon is the lead sponsor of 20 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Men at least 18 years of age that have advanced prostate cancer that is treated with sipuleucel-T
Exclusion Criteria:
Biological: sipuleucel-T
Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
Also known as: PROVENGE, APC8015
To Further Quantify the Risk of Cerebrovascular Events Following Sipuleucel-T Therapy for All Subjects
The incidence rate of CVEs (cardiovascular events) was estimated as the number of new events per 100 patient years of follow-up in the overall sample of men with advanced-stage or metastatic prostate cancer and in men with or without castration.
Time frame: Every 3 months for a minimum of 3 years
Survival
To quantify survival by estimating the median time of survival in all subjects using the Kaplan-Meier method.
Time frame: Every 3 months for a minimum of 3 years
| Milestone | Sipuleucel-T |
|---|---|
| Started | 1976 |
| Completed | 457 |
| Not completed | 1519 |
| Withdrew: Adverse event | 2 |
| Withdrew: Death | 1223 |
| Withdrew: Lost to follow-up | 58 |
| Withdrew: Withdrawal by subject | 88 |
| Withdrew: Unspecified reasons | 104 |
| Withdrew: Study termination | 3 |
| Withdrew: No discontinuation documentation | 41 |
The incidence rate of CVEs (cardiovascular events) was estimated as the number of new events per 100 patient years of follow-up in the overall sample of men with advanced-stage or metastatic prostate cancer and in men with or without castration.
| events per 100 patient years | Sipuleucel-T |
|---|---|
| To Further Quantify the Risk of Cerebrovascular Events Following Sipuleucel-T Therapy for All Subjects | 1.2 |
To quantify survival by estimating the median time of survival in all subjects using the Kaplan-Meier method.
| months | Sipuleucel-T |
|---|---|
| Survival | 30.7 (28.6 to 32.2) |
Collected over All SAEs reported or observed during or following the first infusion through 60 days post final infusion were recorded in subject's medical record and reported on an electronic case report form (eCRF). Data collection continued until every subject had been followed for minimum 3 years, had died, or had otherwise gone off study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sipuleucel-T | 1,223/1,976 (61.9%) | 260/1,902 (13.7%) | 12/1,902 (0.6%) |
| Event | Sipuleucel-T |
|---|---|
| Disease progressionGeneral disorders | 28/1902 |
| Cerebrovascular accidentNervous system disorders | 16/1902 |
| ChillsGeneral disorders | 13/1902 |
| SyncopeNervous system disorders | 12/1902 |
| Device related infectionInfections and infestations | 10/1902 |
| Acute kidney injuryRenal and urinary disorders | 8/1902 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 8/1902 |
| Deep vein thrombosisVascular disorders | 8/1902 |
| AnaemiaBlood and lymphatic system disorders | 7/1902 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 7/1902 |
| Event | Sipuleucel-T |
|---|---|
| Subdural haematomaInjury, poisoning and procedural complications | 2/1902 |
| Cerebrovascular accidentNervous system disorders | 2/1902 |
| Transient ischaemic attackNervous system disorders | 2/1902 |
| Tumour haemorrhageNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/1902 |
| AphasiaNervous system disorders | 1/1902 |
| Cerebral haemorrhageNervous system disorders | 1/1902 |
| Cerebral infarctionNervous system disorders | 1/1902 |
| Ischaemic strokeNervous system disorders | 1/1902 |
| SeizureNervous system disorders | 1/1902 |
The analysis population only includes subjects that received at least one partial infusion of Sip-T.
| Age, Categorical(Participants) | Sipuleucel-T |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 441 |
| >=65 years | 1461 |
| Age, Continuous(Years) | Sipuleucel-T |
|---|---|
| Mean | 71.9 (42 to 97) |
| Sex: Female, Male(Participants) | Sipuleucel-T |
|---|---|
| Female | 0 |
| Male | 1902 |
| Race (NIH/OMB)(Participants) | Sipuleucel-T |
|---|---|
| American Indian or Alaska Native | 6 |
| Asian | 22 |
| Native Hawaiian or Other Pacific Islander | 4 |
| Black or African American | 221 |
| White | 1649 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Sipuleucel-T |
|---|---|
| United States | 1902 |
| Weight(kilogram) | Sipuleucel-T |
|---|---|
| Mean | 91.97 ± 17.67 |
| Height(Centimeters) | Sipuleucel-T |
|---|---|
| Mean | 176.59 ± 7.29 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status(Participants) | Sipuleucel-T |
|---|---|
| ECOG 0=Fully Active; No restrictions | 1265 |
| ECOG 1= Restricted Strenuous Activity | 571 |
| ECOG 2= Capable of selfcare | 34 |
| ECOG 3= Capable of limited selfcare | 8 |
| ECOG Not Reported | 24 |
7 further baseline measures are reported on the registry.
Showing the first 100 of 333 sites.
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Dendreon