Immune drug rituximab tested to shrink prostate tumors before surgery
NCT ID NCT01804712
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tested whether rituximab, a drug that depletes B cells, could reduce immune cell infiltration in prostate tumors. Eight high-risk prostate cancer patients received four weekly doses before their scheduled prostate removal. The main goal was to see if B-cell levels in the tumor decreased after treatment, not to measure cancer outcomes directly.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- rituximab (Rituxan)
- What this could lead to
- If it works, this could point toward a new way to treat high-risk prostate cancer by targeting immune cells that help tumors grow.
- What could go wrong
- This is a very small, early-phase pilot study with only 8 participants, so results may not apply broadly. It is designed mainly to check a biological effect, not to prove the drug works against cancer.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
8 people
The number who actually took part.
- Start date
-
Jul 2013
- Finished
-
Aug 2020
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Male participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Moores UCSD Cancer Center
La Jolla, California, 92093-0698, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- A scanner in the operating room could show surgeons exactly where prostate cancer remains