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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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There is now substantial evidence that B cells are recruited into prostate cancers by CXCL13 released by the tumor cells. B cells release lymphotoxin which drives malignant cell proliferation through the NFkB pathway. This is a pilot trial in 18 patients to determine whether depletion of B cells by rituximab will result in a decrease in the extent of B cell infiltration of the prostatic cancer. The extent of infiltration in the diagnostic biopsy will be compared to that in the prostatectomy samples following administration of 4 weekly doses of rituximab.
This is an open label, single institution, pilot study of rituximab neoadjuvant therapy in patients with high risk prostate cancer scheduled to undergo radical prostatectomy. Prior to prostatectomy, patients will receive one treatment cycle (28 days) of rituximab 375 mg/m2 intravenously once weekly. Patients will be scheduled to undergo radical prostatectomy within two weeks of completing study treatment. Tissue from prostatectomy will be used for immunohistochemistry (IHC) staining of pharmacodynamic markers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rituximab | Experimental | Rituximab will be administered intravenously at a dose of 375 mg/m2 of body surface area once per week for 4 weeks (Days 1, 8, 15, and 22 of a 28-day cycle). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rituximab | Drug | Rituximab will be administered intravenously at a dose of 375 mg/m2 of body surface area once per week for 4 weeks (Days 1, 8, 15, and 22 of a 28-day cycle). |
|
| Measure | Description | Time Frame |
|---|---|---|
| B-cell Density Stained Area | Immunohistochemical staining of serial prostatectomy sections to measure the density of CD20+ B-cells as stained area (mm^2/mm^2) | 1 treatment cycle (28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Prostate-specific Antigen (PSA) | Prostate-specific antigen (PSA) | from Day 1 to Day 29 |
| Change in Tumor B-cell Stained Area | Immunohistochemical staining of serial prostatectomy sections to measure the density of CD20+ B-cells as stained area (mm^2/mm^2) |
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Inclusion Criteria:
Ability to understand and provide written informed consent.
Patient has EITHER:
Indicated for radical prostatectomy.
Note: candidates for radical prostatectomy are still eligible even if they have a history of deep venous thrombosis, pulmonary embolism, and/or cerebrovascular accident or currently requiring systemic anticoagulation.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (Appendix A).
Males aged ≥ 18 years.
Adequate organ function as defined below measured within 21 days of study entry:
Hematology:
Biochemistry:
Available prostate biopsy specimen which is evaluable for B lymphocyte count.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Howell, MD | University of California Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moores UCSD Cancer Center | La Jolla | California | 92093-0698 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32466781 | Result | Ryan ST, Zhang J, Burner DN, Liss M, Pittman E, Muldong M, Shabaik A, Woo J, Basler N, Cunha J, Shalapour S, Estrada MV, Karin M, Messer K, Howell S, Kane CJ, Jamieson CAM. Neoadjuvant rituximab modulates the tumor immune environment in patients with high risk prostate cancer. J Transl Med. 2020 May 28;18(1):214. doi: 10.1186/s12967-020-02370-4. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rituximab | Rituximab will be administered intravenously at a dose of 375 mg/m2 of body surface area once per week for 4 weeks (Days 1, 8, 15, and 22 of a 28-day cycle). rituximab: Rituximab will be administered intravenously at a dose of 375 mg/m2 of body surface area once per week for 4 weeks (Days 1, 8, 15, and 22 of a 28-day cycle). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rituximab | Rituximab will be administered intravenously at a dose of 375 mg/m2 of body surface area once per week for 4 weeks (Days 1, 8, 15, and 22 of a 28-day cycle). rituximab: Rituximab will be administered intravenously at a dose of 375 mg/m2 of body surface area once per week for 4 weeks (Days 1, 8, 15, and 22 of a 28-day cycle). |
| 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 | B-cell Density Stained Area | Immunohistochemical staining of serial prostatectomy sections to measure the density of CD20+ B-cells as stained area (mm^2/mm^2) | Posted | Mean | 95% Confidence Interval | mm^2/mm^2 | 1 treatment cycle (28 days) |
|
|
56 days
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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 | Rituximab | Rituximab will be administered intravenously at a dose of 375 mg/m2 of body surface area once per week for 4 weeks (Days 1, 8, 15, and 22 of a 28-day cycle). rituximab: Rituximab will be administered intravenously at a dose of 375 mg/m2 of body surface area once per week for 4 weeks (Days 1, 8, 15, and 22 of a 28-day cycle). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Grade 4 thromboembolic event | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christopher Kane | University of California, San Diego | (858) 822-5354 | CancerCTO@health.ucsd.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 18, 2023 | Nov 21, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| from Day 1 to Day 29 |
| Tumor CD3+ T-cell Stained Area | Immunohistochemical staining of serial prostatectomy sections to measure the density of CD3+ T-cells as stained area (mm^2/mm^2) | from Day 1 to Day 29 |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| PSA at dx | Mean | Standard Deviation | ng/mL |
|
|
|
| Secondary | Prostate-specific Antigen (PSA) | Prostate-specific antigen (PSA) | Posted | Mean | 95% Confidence Interval | ng/mL | from Day 1 to Day 29 |
|
|
|
| Secondary | Change in Tumor B-cell Stained Area | Immunohistochemical staining of serial prostatectomy sections to measure the density of CD20+ B-cells as stained area (mm^2/mm^2) | Posted | Mean | 95% Confidence Interval | mm^2/mm^2 | from Day 1 to Day 29 |
|
|
|
| Secondary | Tumor CD3+ T-cell Stained Area | Immunohistochemical staining of serial prostatectomy sections to measure the density of CD3+ T-cells as stained area (mm^2/mm^2) | Posted | Mean | 95% Confidence Interval | mm^2/mm^2 | from Day 1 to Day 29 |
|
|
|
| 0 |
| 8 |
| 1 |
| 8 |
| 4 |
| 8 |
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| D000091662 |
| Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |