Prostate CancerEarly Phase 1NCT01804712
Rituximab Neoadjuvant Therapy in Patients With Prostate Cancer Scheduled to Undergo Radical Prostatectomy
A Early Phase 1 study testing rituximab in people with Prostate Cancer, run by Christopher Kane at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to 6 Aug 2020
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and provide written informed consent.
- Patient has EITHER:
- A Kattan nomogram predicted probability of being disease free 5 years after surgery of < 60%, OR
- A Gleason sum ≥ 8.
- 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.
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- 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:
- Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
- Platelet count ≥ 100 x 109/L
- Hemoglobin ≥ 9.0 g/dL
- White blood cell (WBC) count ≥ 3.0 x 109/L
- Biochemistry:
- Aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT) and alanine transaminase/serum glutamate pyruvate transaminase (ALT/SGPT) ≤ 2 x institution's upper limit of normal (ULN)
- Total bilirubin <1.5 times ULN
- Serum creatinine and blood urea nitrogen (BUN)<1.5 times ULN
- Na, K Cl, carbon dioxide (CO2), Ca, phosphate (PO4) within institutional limits
- Available prostate biopsy specimen which is evaluable for B lymphocyte count.
Who cannot join
- Received prior treatment for prostatic adenocarcinoma including prior surgery (excluding TURP), radiation therapy, or chemotherapy.
- Current or past use of investigational agents within 4 weeks of study enrollment.
- Evidence of metastatic disease on cross sectional imaging or bone scan.
- History of hepatitis B or C, hepatitis immunodeficiency virus (HIV), tuberculosis or a chronic infection of any type.
- Positive test results for chronic hepatitis B infection (defined as positive HBsAg serology).
- Positive test results for hepatitis C (hepatitis C virus [HCV] antibody serology testing).
Trial locations and contacts
1 site in 1 country.
United States1 site
Moores UCSD Cancer Center
La Jolla, California, 92093-0698
About this study
Official title: A Pilot Study of Rituximab Neoadjuvant Therapy in Patients With High Risk Prostate Cancer Scheduled to Undergo Radical Prostatectomy
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.
Read the detailed description
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.
- Conditions
- Prostate Cancer
- Being tested
- rituximab
- Keywords
- Prostate, Cancer, Castration-resistant, Rituximab, neoadjuvant, Rituxan
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximabDrug
Also called Rituxan
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 treatment cycle (28 days)
Secondary outcomes (3)
Prostate-specific Antigen (PSA)
Prostate-specific antigen (PSA)
Measured: 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)
Measured: 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)
Measured: from Day 1 to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study startJul 2013
- Primary completion30 Jun 2020
- Study completion6 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christopher Kane
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor-investigator, Christopher Kane, University of California, San Diego
- Investigators
- Stephen Howell, MD, Principal investigator, University of California Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01804712
- Sponsor's protocol ID
- 121451
- Status last verified
- Feb 2026
- First submitted
- 1 Mar 2013
- Last updated
- 12 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 32466781
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Rituximab Neoadjuvant Therapy in Patients With High Risk Prostate Cancer Scheduled to Undergo Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT01804712
- Acronym / sponsor ID
- 121451
- Conditions
- Prostate Cancer
- Keywords
- Prostate, Cancer, Castration-resistant, Rituximab, neoadjuvant, Rituxan
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Christopher KaneUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Jul 2013
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 6 Aug 2020 (actual)
- First posted
- 5 Mar 2013 (estimated)
- Results
- Posted 12 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rituximab | Experimental | Drug: rituximabRituximab 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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).
Key exclusion criteria (6 listed)
- Received prior treatment for prostatic adenocarcinoma including prior surgery (excluding TURP), radiation therapy, or chemotherapy.
- Current or past use of investigational agents within 4 weeks of study enrollment.
- Evidence of metastatic disease on cross sectional imaging or bone scan.
- History of hepatitis B or C, hepatitis immunodeficiency virus (HIV), tuberculosis or a chronic infection of any type.
- Positive test results for chronic hepatitis B infection (defined as positive HBsAg serology).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rituximabAlso: RituxanRituximab 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). | Drug | rituximab |
Primary outcome
B-cell Density Stained Area
Time frame: 1 treatment cycle (28 days)
Immunohistochemical staining of serial prostatectomy sections to measure the density of CD20+ B-cells as stained area (mm^2/mm^2)
3 secondary outcomes
Prostate-specific Antigen (PSA)
Time frame: from Day 1 to Day 29
Change in Tumor B-cell Stained Area
Time frame: from Day 1 to Day 29
Tumor CD3+ T-cell Stained Area
Time frame: from Day 1 to Day 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32466781Ryan 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Howell, MD principal investigator
University of California Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing rituximab in people with Prostate Cancer, run by Christopher Kane at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
B-cell Density Stained Area (time frame: 1 treatment cycle (28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01804712, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.