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.

Metastatic Castration-Resistant Prostate Adenocarcinoma Clinical Trial in Duarte, CA

Q: Is NCT07219147 recruiting in Duarte, CA?

Yes, NCT07219147 is currently recruiting participants at its Duarte, CA location. This metastatic castration-resistant prostate adenocarcinoma clinical trial is actively enrolling qualified participants.

Q: How do I join the metastatic castration-resistant prostate adenocarcinoma 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 Metastatic Castration-Resistant Prostate Adenocarcinoma Study in Duarte

This phase I trial compares the effect of lutetium Lu 177 (177\^Lu)-prostate-specific membrane antigen (PSMA)-617 in combination with Sipuleucel-T to 177\^Lu-PSMA-617 alone in treating patients with prostate that has spread from where it first started (primary site) to other places in the body (metastatic) and has continued to grow and spread despite surgical or medical intervention to block androgen production (castration-resistant). 177\^Lu-PSMA-617, a type of radioconjugate, binds to a protein called PSMA, which is found on some prostate tumor cells. It gives off radiation that may kill the tumor cells. Sipuleucel-T, a type of vaccine and a type of cellular adoptive immunotherapy, is made from immune system cells. The cells are treated with a protein that is made by combining a protein found on prostate tumor cells with a growth factor. When the cells are injected back into the patient, they may stimulate T cells to kill prostate tumor cells. Giving 177\^Lu-PSMA-617 in combination with sipuleucel-T may be safe, tolerable, and/or effective compared to 177\^Lu-PSMA-617 alone in treating patients with metastatic 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

Assent, when appropriate, will be obtained per institutional guidelines

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) ≤ 1

Progressive castration-resistant metastatic prostate cancer with pathologically confirmed adenocarcinoma of the prostate without small cell features

Patients must have either:

Measurable disease

For extranodal (visceral) lesions (e.g. lung, liver, etc.) to be considered measurable, they must be ≥ 10 mm in one dimension, using spiral CT

For lymph nodes to be considered measurable (i.e., target or evaluable lesions), they must be ≥ 20 mm in at least one dimension, using spiral CT

OR non-measurable disease

All other lesions, including small lesions (longest diameter \< 20 mm with conventional techniques or \< 10 mm with spiral CT scan) and truly non-measurable lesions

Lesions that are considered non-measurable include bone lesions (only). Progression on first generation ADT

Patients must have been on androgen deprivation therapy with a gonadotrophin releasing hormone (GnRH) analogue, antagonist, or bilateral orchiectomy (i.e., surgical or medical castration) for at least 3 months prior to study entry and maintain castrate levels of serum testosterone \< 50 ng/dL throughout study participation unless intolerant

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

Absolute neutrophil count (ANC) ≥ 1,500/mm\^3 (within 10 days prior to day 1 of protocol therapy)

White blood cell (WBC) counts \> 2500/uL (within 10 days prior to day 1 of protocol therapy)

Lymphocyte count ≥ 300/uL (within 10 days prior to day 1 of protocol therapy)

Platelets ≥ 100,000/mm\^3 (within 10 days prior to day 1 of protocol therapy)

Hemoglobin ≥ 9g/dL (within 10 days prior to day 1 of protocol therapy)

NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment unless cytopenia is secondary to disease involvement

Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (within 10 days prior to day 1 of protocol therapy) (unless has Gilbert's disease, serum bilirubin level ≤ 3 x ULN)

Aspartate aminotransferase (AST) ≤ 2.5 x ULN (within 10 days prior to day 1 of protocol therapy)

Alanine aminotransferase (ALT) ≤ 3.0 x ULN (within 10 days prior to day 1 of protocol therapy)

Alkaline phosphatase ≤ 3 x ULN (within 10 days prior to day 1 of protocol therapy) (Patients with documented bone metastases, alkaline phosphatase \[ALP\] ≤ 5 x ULN)

Serum creatinine ≤ 1.5 x ULN or creatinine clearance of ≥ 50 mL/min per Cockcroft-Gault formula (within 10 days prior to day 1 of protocol therapy)

If not receiving anticoagulants: International normalized ratio (INR) OR prothrombin (PT) ≤ 1.5 x ULN (within 10 days prior to day 1 of protocol therapy)

If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants (within 10 days prior to day 1 of protocol therapy)

If not receiving anticoagulants: Activated partial thromboplastin time (aPTT) ≤ 1.3 x ULN (within 10 days prior to day 1 of protocol therapy)

If on anticoagulant therapy: aPTT must be within therapeutic range of intended use of anticoagulants (within 10 days prior to day 1 of protocol therapy)

Seronegative for HIV antigen (Ag)/antibody (Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative), and syphilis (rapid plasma reagin \[RPR\]) (within 10 days prior to day 1 of protocol therapy)

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

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

For male patients with partners of childbearing potential, agreement (by patient and/or partner) to use highly effective form(s) of contraception or abstain from heterosexual activity for the course of the study through at least 4 months after the last dose of protocol therapy

Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)

Exclusion Criteria

Any approved or investigational anticancer therapy, including chemotherapy, hormonal therapy (e.g., androgen receptor \[AR\] antagonists, 5 alpha reductase inhibitor, estrogen), or radiotherapy, within 4 weeks prior to initiation of study treatment

Treatment with any of the following medications or interventions within 28 days of registration:

External beam radiation therapy or surgery

Chrysanthemum morifolium/Ganoderma lucidum/Glycyrrhiza glabra/Isatis indigotica/Panax pseudoginseng/Rabdosia rubescens/Scutellaria baicalensis/Serona repens supplement (PC-SPES) (or PC-SPEC) or saw palmetto

Systemic corticosteroids. Use of inhaled, intranasal, and topical steroids is acceptable

Megestrol acetate (Megace®), diethyl stilbestrol (DES), or cyproterone acetate

Ketoconazole

5-alpha-reductase inhibitors (e.g., finasteride \[Proscar®\], dutasteride \[Avodart®\])

High dose calcitriol (1,25\[OH\]2 vitamin \[Vit\]D) (i.e., \> 7.0 ug/week)

Prior treatment with 177\^Lu-PSMA-617 and/or sipuleucel-T

Radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment

Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease

Treatment with any investigational vaccine within 2 years of registration or treatment with any other investigational product within 28 days of registration

Patients with acute leukemias, accelerated/blast-phase chronic myelogenous leukemia, chronic lymphocytic leukemia, Burkitt lymphoma, plasma cell leukemia, or non-secretory myeloma

Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases

Inability to comply with study and follow-up procedures

Any other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 3 years prior to first dose of study treatment that requires active treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast

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 (NCT07219147) 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.

Metastatic Castration-Resistant Prostate Adenocarcinoma Treatment Options in Duarte, CA

If you're searching for metastatic castration-resistant prostate adenocarcinoma treatment options in Duarte, CA, this clinical trial (NCT07219147) 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 clinical trial. You'll receive care from experienced metastatic castration-resistant prostate adenocarcinoma 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 metastatic castration-resistant prostate adenocarcinoma clinical trials near you to find additional studies recruiting in your area.

Metastatic Castration-Resistant Prostate Adenocarcinoma Clinical Trial in Duarte, CA

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