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Immune drug rituximab tested to shrink prostate tumors before surgery

NCT ID NCT01804712

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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

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