Is NCT06039371 recruiting in Seattle, WA?

Yes, NCT06039371 is currently recruiting participants at its Seattle, WA location. This castration-resistant prostate carcinoma clinical trial is actively enrolling qualified participants.

Is participation in this Seattle 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 Seattle, WA

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

To join this clinical trial in Seattle, 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 Seattle

This phase II trial studies how well giving testosterone at levels higher than normally found in the body (supraphysiological) works to enhance chemotherapy treatment, and Lutetium 177Lu-prostate specific-membrane antigen (PSMA)-617 (LuPSMA) in patients with prostate cancer that has progressed despite being previously treated with androgen therapies and has spread from where it first started (prostate) to other places in the body (metastatic castration-resistant prostate cancer). In patients that have developed progressive cancer in spite of standard hormonal treatment, administering supraphysiological testosterone may result in regression of tumors by causing deoxyribonucleic acid (DNA) damage in tumor cells that have adapted to low testosterone conditions. Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Radioactive drugs, such as LuPSMA, may carry radiation directly to tumor cells and not harm normal cells. Giving supraphysiological levels of testosterone and carboplatin or etoposide or LuPSMA together may be an effective treatment for metastatic castration-resistant prostate cancer.

Sponsor: University of Washington

Who Can Participate

Inclusion Criteria

Must be willing to provide informed consent prior to any study specific procedures

Age \>= 18 years

Documented histologically confirmed adenocarcinoma of the prostate

Patient must have evidence of castration resistant prostate cancer as evidenced by PSA progression (per Prostate Cancer Working Group 3 \[PCWG3\] criteria) and a castrate serum testosterone level (i.e., =\< 50 mg/dL)

PSA must be at least 2 ng/ml and rising on two successive measurements at least two weeks apart

Patients must have progressed on at least one prior next-generation androgen receptor-signalling inhibitor (e.g., abiraterone, enzalutamide, etc.). There must be at least a 2-week washout period after stopping the most recent approved therapy for metastatic castration-resistant prostate cancer (mCRPC) (e.g., abiraterone, enzalutamide, Ra-223, sipuleucel-t) prior to cycle 1, day 1. If applicable, patients should be weaned off steroids at least 1 week prior to starting treatment

Subjects enrolling to Cohort 3 must demonstrate evidence of PSMA expression on 68Ga-PSMA-11 PET as defined in the VISION trial

No prior chemotherapy for the treatment of mCRPC. Patients may have received docetaxel for the treatment of hormone-sensitive prostate cancer

Prior treatment with non-chemotherapy investigational agents is permitted. There must be at least a 2-week washout period after stopping any investigational cancer agent prior to cycle 1, day 1

Hemoglobin \>= 9 g/dL with no blood transfusion in the past 28 days (within 30 days prior to administration of study treatment)

Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L (within 30 days prior to administration of study treatment)

Platelet count \>= 100 x 10\^9/L (within 30 days prior to administration of study treatment)

Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) (within 30 days prior to administration of study treatment)

Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) / alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional upper limit of normal unless liver metastases are present in which case they must be =\< 5x ULN (within 30 days prior to administration of study treatment)

Patients must have creatinine clearance estimated using the Cockcroft-Gault equation or based on 24 hour urine test of \>= 51 mL/min (within 30 days prior to administration of study treatment)

Eastern Cooperative Oncology Group (ECOG) performance status =\< 2

Patients must have a life expectancy \>= 16 weeks

Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations

At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by CT, positron emission tomography (PET), magnetic resonance imaging (MRI) and/or bone scan and is suitable for repeated assessment

Must be willing to undergo metastatic biopsy and have a lesion amenable for biopsy

Male patients and their partners, who are sexually active and of childbearing potential, must agree to the use of two highly effective forms of contraception in combination, throughout the period of taking study treatment and for 6 months after last dose of study drug(s) to prevent pregnancy in a partner

Exclusion Criteria

Involvement in the planning and/or conduct of the study

Other malignancy unless curatively treated with no evidence of disease for \>= 2 years except: adequately treated non-melanoma skin cancer, non-muscle invasive bladder cancer

Persistent toxicities (Common Terminology Criteria for Adverse Event (CTCAE) grade \> 2) caused by previous cancer therapy, excluding alopecia

Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days

Use of corticosteroids at a dose equivalent to \> 10 mg of prednisone daily

Planning to receive concurrent treatment with another systemic cancer therapy, aside from a luteinizing hormone releasing hormone (LHRH) analogue

Use of warfarin is not permitted. Low-molecular weight heparin and direct oral anticoagulants are allowed, but their use should be discussed with the principal investigator (PI) first

Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery

Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, uncontrolled major seizure disorder, uncontrolled hypertension (blood pressure \[BP\] \>= 165/100), history of prior stroke, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease or any psychiatric disorder that prohibits obtaining informed consent

Patients with a known hypersensitivity to the testosterone cypionate, etoposide, carboplatin or any of the excipients of these products

Patients with known active hepatitis (i.e., hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids

Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study

Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule

Evidence of disease that, in the opinion of the investigator, would put the patient at risk from testosterone therapy (e.g. femoral metastases with concern over fracture risk, spinal metastases with concern over spinal cord compression, lymph node disease with concern for ureteral obstruction)

Patients with pain attributable to their prostate cancer.

Excluded due to concern for pain flare due to testosterone supplementation

Tumor causing urinary outlet obstruction that requires catheterization for voiding. Patients that require catheterization to void secondary to benign strictures or other non-cancer causes will be permitted to enroll. Patients with percutaneous nephrostomy tubes will also be permitted to enroll

Prior history of deep venous thrombosis or pulmonary embolism within 5 years prior to enrollment in the study and not currently on systemic anticoagulation.

Excluded due to risk of venous thromboembolism from hormone supplementation

Patients with NYHA (New York Heart Association) class III or IV heart failure or history of a prior myocardial infarction (MI) within 5 years of enrollment to the study.

Excluded due to increased risk of cardiovascular events with testosterone supplementation

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 Seattle?

Yes, this clinical trial (NCT06039371) has an active research site in Seattle, WA 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 Seattle, WA

If you're searching for castration-resistant prostate carcinoma treatment options in Seattle, WA, this clinical trial (NCT06039371) 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 Seattle research site is actively enrolling participants for this phase 2 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 Seattle, WA

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