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New treatment option for Castration-Resistant Prostate Carcinoma
Official title Schedule De-Escalation of 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer
ClinicalTrials.gov ID: NCT06200103
What this study is testing
What is Lutetium Lu 177 Vipivotide Tetraxetan?
Lutetium Lu 177 Vipivotide Tetraxetan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for castration-resistant prostate carcinoma.
Also referred to as 177Lu-labeled PSMA-617, 177Lu-PSMA-617.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- REGISTRATION 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...
- Willingness to provide mandatory blood draws for correlative research. (This requirement is waived for patients enrolling after receiving cycle 1 of...
- Provide written informed consent
- Ability to complete questionnaire(s) by themselves or with assistance
You likely can't join if
- 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:
See the full eligibility criteria
- REGISTRATION 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...
- 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...
- 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 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...
- 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...
- 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 (CROSSOVER TO COMPLETION UPON FIRST PROGRESSION OF PATIENTS assigned by chance TO TREATMENT PAUSE)
- First progression in patients assigned by chance to pause treatment
- PSMA avid lesions on PSMA PET (miPSMA score ≥ 2 following first progression)
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.