Is NCT05805371 recruiting in Duarte, CA?

Yes, NCT05805371 is currently recruiting participants at its Duarte, CA location. This castration-resistant prostate carcinoma clinical trial is actively enrolling qualified participants.

Is participation in this Duarte clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Castration-Resistant Prostate Carcinoma Clinical Trial in Duarte, CA

Q: How do I join the castration-resistant prostate carcinoma clinical trial in Duarte?

To join this clinical trial in Duarte, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Castration-Resistant Prostate Carcinoma Study in Duarte

This phase Ib trial tests the safety, side effects, and best dose of autologous anti-prostate stem cell antigen (PSCA)-chimeric antigen receptor (CAR)-4-1BB/TCRzeta-CD19t-expressing T-lymphocytes (PSCA-CAR T cells), plus or minus radiation, in treating patients with castration-resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Castration-resistant prostate cancer continues to grow and spread despite the surgical removal of the testes or medical intervention to block androgen production. CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. Giving PSCA-targeting CAR T-cells, with or without radiation, may kill more tumor cells in men with castration-resistant prostate cancer.

Sponsor: City of Hope Medical Center

Who Can Participate

Inclusion Criteria

Documented informed consent of the participant and/or legally authorized representative (brown)

Assent, when appropriate, will be obtained per institutional guidelines

Note: For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter/translator to proceed with screening and leukapheresis, while the request for a translated main consent is processed. However, the research participant is allowed to proceed with lymphodepletion and CAR T cell infusion only after the translated main consent form is signed

Agreement to allow the use of archival tissue from diagnostic tumor biopsies

If unavailable, exceptions may be granted with study principal investigator (PI) approval

Age: \>= 18 years

Eastern Cooperative Oncology Group (ECOG) performance status 0-2 or Karnofsky Performance Status (KPS) \>= 70%

Documented castration resistant prostate cancer (mCRPC) (Note: castration will be defined by a testosterone \< 50 ng/dL achieved by orchiectomy or luteinizing hormone-releasing hormone \[LHRH\] agonist/antagonist therapy)

Documented PSCA+ tumor expression as evaluated by the COH Pathology Clinical Trials Specimen Qualification Laboratory (CTSQL)

Fresh or archival biopsy samples may be tested for PSCA expression during screening for eligibility purposes. The results from soft tissue biopsies will be used to confirm eligibility for participants who have a soft-tissue lesion biopsy obtained, but bone biopsy staining results will not impact eligibility since immunohistochemistry (IHC) staining for PSCA has not been optimized in bone specimens. Subjects who undergo bone biopsy on study will be qualified based on the archival tissue result

Progression of disease manifest by one of the following means during treatment with at least one advanced androgen targeted therapy (e.g., abiraterone or enzalutamide):

Rising prostate specific antigen (PSA) documented on 2 occasions at least 7 days apart, with absolute increase \> 2 ng/dL despite testosterone \< 50 OR

Radiographic evidence of new metastatic foci on CT or bone scan, or soft tissue progression by Response Evaluation Criteria in Solid Tumors (RECIST)

For treatment plan 2, subjects must have at least one and up to 3 metastatic lesions which have not previously been radiated and which is safe for treatment with radiation 16 gray (Gy) in 2 fractions

Fully recovered from the acute toxic effects (except alopecia) to =\< grade 1 to prior anti-cancer therapy

If there has been prior chemotherapy, at least 2 weeks must have elapsed prior to leukapheresis

Prior radiotherapy is allowed provided it was not administered to the only evaluable site of disease and was completed \> 14 days prior to leukapheresis

No known contraindications to leukapheresis, steroids or tocilizumab

Absolute neutrophil count (ANC) \>= 1,000/mm\^3 (within 42 days prior to enrollment)

NOTE: Growth factor is not permitted within 14 days of ANC assessment

Platelets \>= 100,000/mm\^3 (within 42 days prior to enrollment) NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment

Total serum bilirubin =\< 2.0 mg/dL (within 42 days prior to enrollment)

Patients with Gilbert syndrome may be included if their total bilirubin is =\< 3.0 x upper limit of normal (ULN) and direct bilirubin =\< 1.5 x ULN

Aspartate aminotransferase (AST) =\< 2.5 x ULN (within 42 days prior to enrollment)

Alanine aminotransferase (ALT) =\< 2.5 x ULN (within 42 days prior to enrollment)

Creatinine clearance of \>= 50 mL/min per 24 hour urine test or the Cockcroft-Gault formula (within 42 days prior to enrollment)

Corrected QT interval (QTc) =\< 480 ms

Note: to be performed within 28 days prior to day 1 of protocol therapy

Cardiac function (12 lead- electrocardiogram \[ECG\]) without acute abnormalities requiring investigation or intervention (within 42 days prior to enrollment)

Seronegative for human immunodeficiency virus (HIV) antigen (Ag)/antibody (Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative), and syphilis (rapid plasma reagin \[RPR\])

If positive, hepatitis C ribonucleic acid (RNA) quantitation must be performed OR

If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable

Note infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy

Meets other institutional and federal requirements for infectious disease titer requirements

Note Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy

Agreement by males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of protocol therapy

Childbearing potential defined as not being surgically sterilized

Exclusion Criteria

Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled steroids is not exclusionary. Physiologic replacement of steroids (prednisone =\< 7.5 mg /day, or hydrocortisone =\< 20 mg /day) is allowed

Subjects with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of screening

Subjects with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system, including seizure disorder

History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent

Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia

History of stroke or intracranial hemorrhage within 6 months prior to screening

History of other malignancies, except for malignancy surgically resected (or treated with other modalities) with curative intent, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; non-muscle invasive bladder cancer; malignancy treated with curative intent with no known active disease present for \>= 3 years

Clinically significant uncontrolled illness

Active infection requiring antibiotics

Known history of immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection

Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures

Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Duarte?

Yes, this clinical trial (NCT05805371) has an active research site in Duarte, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Castration-Resistant Prostate Carcinoma Treatment Options in Duarte, CA

If you're searching for castration-resistant prostate carcinoma treatment options in Duarte, CA, this clinical trial (NCT05805371) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Duarte research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced castration-resistant prostate carcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all castration-resistant prostate carcinoma clinical trials near you to find additional studies recruiting in your area.

Castration-Resistant Prostate Carcinoma Clinical Trial in Duarte, CA

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