Is NCT06200103 recruiting in Rochester, MN?

Yes, NCT06200103 is currently recruiting participants at its Rochester, MN location. This castration-resistant prostate carcinoma clinical trial is actively enrolling qualified participants.

Is participation in this Rochester 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 Rochester, MN

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

To join this clinical trial in Rochester, 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 Rochester

This phase II trial studies how to improve the usage of Lu 177 vipivotide tetraxetan (177Lu-prostate-specific membrane antigen \[PSMA\]-617) for treating patients with castration-resistant prostate cancer that has spread from where it first started (primary site), to other places in the body (metastatic) utilizing a treatment pause after 5 cycles of therapy versus standard continuous treatment for 6 cycles. Lutetium is a radioligand therapy (RLT). RLT uses a small molecule (in this case 177Lu-PSMA-617) that carries a radioactive component to destroy tumor cells. When lutetium is injected into the body, it attaches to the PSMA receptor found on tumor cells. After lutetium attaches to the PSMA receptor, its radiation component destroys the tumor cell. Giving 177Lu-PSMA-617 for 5 cycles versus 6 cycles may better treat patients with metastatic castrate resistant prostate cancer.

Sponsor: Mayo Clinic

Who Can Participate

Inclusion Criteria

REGISTRATION INCLUSION CRITERIA

Scheduled at Mayo Clinic Rochester for therapy with 177Lu PSMA-617

PSMA positive metastatic castration resistant prostate cancer (68Ga and 18F PSMA PET will be considered equivalent for eligibility) , defined by molecular imaging prostate specific membrane antigen (miPSMA) score \>= 2 on Mayo PET report, including interpretation of outside PET or consensus review of PET by nuclear therapy tumor board note in the patient chart

Willingness to provide mandatory blood draws for correlative research. (This requirement is waived for patients enrolling after receiving cycle 1 of 177Lu PSMA-617,and achieving a near complete response on post therapy SPECT, as these patients will not be able to provide a pre-treatment baseline blood sample.)

Provide written informed consent

Ability to complete questionnaire(s) by themselves or with assistance

Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)

RANDOMIZATION INCLUSION CRITERIA

Lesions with uptake equal to or above liver on cycle 1 post therapy SPECT, demonstrating that a near complete response on follow up post-therapy scan represents response, rather than sensitivity differences between SPECT and pre-treatment PET

Near-complete response on post-therapy SPECT following any of cycles 2-5 of 177Lu PSMA-617. Near-complete response will be defined as no lesions with SUV max above the mean standard uptake value (SUV) of a representative 2cm spherical region of interest in the central right hepatic lobe, as determined by a nuclear medicine trained radiologist

No toxicity that would indicate withholding or reducing dose of the next scheduled cycle of 177Lu PSMA-617 per prescribing information

Hemoglobin (Hgb) ≥ 8 g/dL

Platelets ≥ 75,000/mm\^3

Neutrophils ≥ 100/mm\^3

Estimated glomerular filtration rate (eGFR) \< 50 mL/min \*body surface area (BSA) using Cockcroft-Gault formula OR

Creatinine ≤ 1.5 x upper limit of normal

Aspartate transferase (AST) or alanine transaminase (ALT) ≤ 3 x upper limit of normal

No other unacceptable toxicity in the clinical judgement of the investigators

RE-REGISTRATION INCLUSION CRITERIA (CROSSOVER TO COMPLETION UPON FIRST PROGRESSION OF PATIENTS RANDOMIZED TO TREATMENT PAUSE)

First progression in patients randomized to pause treatment

PSMA avid lesions on PSMA PET (miPSMA score ≥ 2 following first progression)

Exclusion Criteria

REGISTRATION EXCLUSION CRITERIA

Another active malignancy requiring therapy such as radiation, chemotherapy, or immunotherapy

Receiving any other investigational agent which would be considered as a treatment for the prostate cancer

Failure to recover from acute, reversible effects of prior therapy regardless of interval since last treatment

EXCEPTION: Grade 1 peripheral (sensory) neuropathy that has been stable for at least 3 months since completion of prior treatment

Uncontrolled intercurrent non-cardiac illness including, but not limited to:

Ongoing or active infection

Psychiatric illness/social situations

Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy

Any other conditions that would limit compliance with study requirements

Any of the following because this study involves: An investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown

Persons able to father a child who are unwilling to employ adequate contraception

Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

History of myocardial infarction ≤6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias

RE-REGISTRATION EXCLUSION CRITERIA

Serious adverse effect

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 Rochester?

Yes, this clinical trial (NCT06200103) has an active research site in Rochester, MN 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 Rochester, MN

If you're searching for castration-resistant prostate carcinoma treatment options in Rochester, MN, this clinical trial (NCT06200103) 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 Rochester research site is actively enrolling participants for this 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 Rochester, MN

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