mCRPC: Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer
Study Details
Study Description
Brief Summary
Multicenter open label, uncontrolled study that enrolled men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. The study was divided into Active and Long Term Follow-up (LTFU) Phases.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Multicenter open label, uncontrolled study that enrolled men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. The study was divided into Active and Long Term Follow-up (LTFU) Phases.
During the Active Phase eligible subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions. Subjects returned to the clinic for Week 6, Week 10, Month 6, and Month 12 visits. After the Month 12 visit, subjects were to enter the Long Term Follow-up Phase, in which they were contacted every 6 months via telephone.
Study Objectives:
Primary: Evaluate the immune response generated by sipuleucel-T.
Secondary: Evaluate the safety of sipuleucel-T and explore the correlation between sipuleucel-T immune response and overall survival.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: sipuleucel-T Men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. Subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions. |
Biological: sipuleucel-T
Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Study Participants Enrolled and Treated Prior to Study Termination [Study duration: date of first subject registration Dec 2011 and date of last subject visit April 2015]
Number of study participants that were enrolled and treated in this trial following completion of study P-11 and prior to study termination.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Previously randomized in Dendreon's P-11 study (NCT00779402) and received at least one infusion of sipuleucel-T
-
Radiologic evidence of metastasis
-
Castrate resistant prostate cancer. Subjects must have current or historical evidence of disease progression concomitant with surgical or medical castration, as demonstrated by PSA progression OR progression of measurable disease OR progression of non-measurable disease
-
Castrate level of testosterone (< 50 ng/dL) achieved via medical or surgical castration
-
Adequate hematologic function
Exclusion Criteria:
-
Eastern Cooperative Oncology Group (ECOG) performance status > 2
-
Treatment with chemotherapy within 3 months prior to registration
-
Treatment with systemic corticosteroids, abiraterone acetate, external beam radiation therapy, or any investigational product for prostate cancer within 28 days prior to registration
-
Treatment with commercial sipuleucel-T (Provenge®)
-
Current or imminent pathologic long-bone fracture or spinal cord compression
-
Known malignancies other than prostate cancer likely to require treatment within 6 months following registration
-
A requirement for systemic immunosuppressive therapy for any reason
-
A history of allergic reactions attributed to compounds of similar chemical or biologic composition to sipuleucel-T or GM-CSF
-
Any infection requiring antibiotic therapy or causing fever within 1 week prior to registration
-
Any surgery requiring general anesthetic within 28 days prior to registration
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Orange County Urology Associates | Laguna Hills | California | United States | 92653 |
| 2 | Oregon Health & Science University | Portland | Oregon | United States | 97239 |
| 3 | Virginia Mason Hospital | Seattle | Washington | United States | 98101 |
| 4 | Virginia Mason Medical Center | Seattle | Washington | United States | 98101 |
Sponsors and Collaborators
- Dendreon
Investigators
- Study Director: Robert Israel, MD, Valeant Pharmaceuticals North America LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P10-1
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Sipuleucel-T |
|---|---|
| Arm/Group Description | Men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. Subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions. |
| Period Title: Overall Study | |
| STARTED | 8 |
| COMPLETED | 0 |
| NOT COMPLETED | 8 |
Baseline Characteristics
| Arm/Group Title | Sipuleucel-T |
|---|---|
| Arm/Group Description | Men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. Subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions. |
| Overall Participants | 8 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
0
0%
|
| >=65 years |
8
100%
|
| Age (years) [Mean (Full Range) ] | |
| Mean (Full Range) [years] |
74.4
|
| Sex: Female, Male (Count of Participants) | |
| Female |
0
0%
|
| Male |
8
100%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
8
100%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (Count of Participants) | |
| United States |
8
100%
|
| Eastern Cooperative Oncology Group (ECOG) performance status (Count of Participants) | |
| ECOG 0=Fully Active; No restrictions |
6
75%
|
| ECOG 1= Restricted Strenuous Activity |
2
25%
|
Outcome Measures
| Title | Number of Study Participants Enrolled and Treated Prior to Study Termination |
|---|---|
| Description | Number of study participants that were enrolled and treated in this trial following completion of study P-11 and prior to study termination. |
| Time Frame | Study duration: date of first subject registration Dec 2011 and date of last subject visit April 2015 |
Outcome Measure Data
| Analysis Population Description |
|---|
| This study was terminated early due to administrative reasons. Only eight subjects out of the ninety subjects planned were enrolled and treated. Given the small number of patients enrolled, results should be interpreted with caution. |
| Arm/Group Title | Sipuleucel-T |
|---|---|
| Arm/Group Description | Men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. Subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions. |
| Measure Participants | 8 |
| Count of Participants [Participants] |
8
100%
|
Adverse Events
| Time Frame | Active phase (screening to Month 12) Follow-up phase: After Month 12 visit to end of study participation | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Sipuleucel-T | |
| Arm/Group Description | Men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. Subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions. | |
All Cause Mortality |
||
| Sipuleucel-T | ||
| Affected / at Risk (%) | # Events | |
| Total | 4/8 (50%) | |
Serious Adverse Events |
||
| Sipuleucel-T | ||
| Affected / at Risk (%) | # Events | |
| Total | 2/8 (25%) | |
| Blood and lymphatic system disorders | ||
| Anaemia | 1/8 (12.5%) | 2 |
| Thrombocytopenia | 1/8 (12.5%) | 1 |
| Cardiac disorders | ||
| Acute myocardial infarction | 1/8 (12.5%) | 1 |
| Gastrointestinal disorders | ||
| Gastrointestinal haemorrhage | 1/8 (12.5%) | 1 |
| Peptic ulcer | 1/8 (12.5%) | 1 |
| General disorders | ||
| Device alarm issue | 1/8 (12.5%) | 1 |
| Infections and infestations | ||
| Pneumonia | 1/8 (12.5%) | 1 |
| Injury, poisoning and procedural complications | ||
| Cystitis radiation | 1/8 (12.5%) | 1 |
| Nervous system disorders | ||
| Cerebrovascular accident | 1/8 (12.5%) | 2 |
| Renal and urinary disorders | ||
| Haematuria | 1/8 (12.5%) | 3 |
Other (Not Including Serious) Adverse Events |
||
| Sipuleucel-T | ||
| Affected / at Risk (%) | # Events | |
| Total | 8/8 (100%) | |
| Eye disorders | ||
| Eye pain | 1/8 (12.5%) | 1 |
| Gastrointestinal disorders | ||
| Nausea | 2/8 (25%) | 2 |
| Paraesthesia oral | 1/8 (12.5%) | 1 |
| Vomiting | 1/8 (12.5%) | 2 |
| General disorders | ||
| Chills | 5/8 (62.5%) | 6 |
| Fatigue | 4/8 (50%) | 9 |
| Pyrexia | 2/8 (25%) | 2 |
| Asthenia | 1/8 (12.5%) | 1 |
| Malaise | 1/8 (12.5%) | 1 |
| Pain | 1/8 (12.5%) | 3 |
| Infections and infestations | ||
| Sinusitis | 2/8 (25%) | 2 |
| Injury, poisoning and procedural complications | ||
| Citrate toxicity | 1/8 (12.5%) | 2 |
| Musculoskeletal and connective tissue disorders | ||
| Arthralgia | 3/8 (37.5%) | 3 |
| Joint stiffness | 2/8 (25%) | 4 |
| Back pain | 1/8 (12.5%) | 2 |
| Neck pain | 1/8 (12.5%) | 1 |
| Nervous system disorders | ||
| Headache | 2/8 (25%) | 3 |
| Paraesthesia | 2/8 (25%) | 3 |
| Psychiatric disorders | ||
| Anxiety | 1/8 (12.5%) | 1 |
| Renal and urinary disorders | ||
| Renal failure | 1/8 (12.5%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Cough | 1/8 (12.5%) | 1 |
| Dyspnoea | 1/8 (12.5%) | 1 |
| Pleural effusion | 1/8 (12.5%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Erythema | 1/8 (12.5%) | 1 |
| Pruritus | 1/8 (12.5%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The results of the Study will be published and/or presented in an integrated manner reflecting the results observed across all participating center. 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.
Results Point of Contact
| Name/Title | Shabnam Vaziri |
|---|---|
| Organization | Dendreon |
| Phone | 206-455-2323 |
| svaziri@dendreon.com |
- P10-1