Fractionated and Multiple Dose 225Ac-J591 for Progressive mCRPC (NCT04506567) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Fractionated and Multiple Dose 225Ac-J591 for Progressive mCRPC
United States60 participantsStarted 2020-08-18
Plain-language summary
The purpose of the initial (phase I) portion of this study is to find a dose level and administration schedule of the study drug, 225Ac-J591, that can be given without severe side effects. The purpose of the second (phase II) portion of the study is to determine the proportion of those with PSMA-positive tumors with \>50% PSA decline following 225Ac-J591 treatment in two regimens.
Who can participate
Age range
18 Years – 99 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histologically or cytologically confirmed adenocarcinoma of prostate
. Documented progressive metastatic CRPC based on Prostate Cancer Working
. Have serum testosterone \< 50 ng/dL. Subjects must continue primary androgen deprivation with an LHRH/GnRH analogue (agonist/antagonist) if they have not undergone orchiectomy
. Have previously been treated with at least one of the following in any disease state:
. Have previously received taxane chemotherapy (in any disease state), been determined to be ineligible for taxane chemotherapy by their physician, or refused taxane chemotherapy.
. Age \> 18 years
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with dose limiting toxicity (DLT)
Timeframe: Collected from Day 1 through 6 months
2
Cumulative maximum tolerated dose (MTD)
Timeframe: Collected from Day 1 through 6 months
3
Recommended phase II dose (RP2D) of 225Ac-J591 in fractionated dose and multiple dose regimens both pre- and post-treatment with 177Lu-PSMA-RL
Timeframe: Collected from Day 1 through 6 months
4
Proportion of participants with PSMA-positive tumors with >50% PSA decline following 225Ac-J591 in two regimens both pre- and post- treatment with 177Lu-PSMA-RL
Timeframe: Collected from Day 1 through 6 months
Trial details
NCT IDNCT04506567
SponsorWeill Medical College of Cornell University
. Patients must have normal organ and marrow function as defined below:
. ECOG performance status of 0-2
Exclusion criteria
. Implantation of investigational medical device ≤4 weeks of Treatment Visit 1 (Day 1) or current enrollment in oncologic investigational drug or device study
. Use of investigational drugs ≤4 weeks or \<5 half-lives of Cycle 1, Day 1 or current enrollment in investigational oncology drug or device study
. For patients enrolled in the post-177Lu-PSMA-RL cohorts: prior radium-223
. Untreated hydronephrosis
. Known active brain metastases or leptomeningeal disease
. History of deep vein thrombosis and/or pulmonary embolus within 1 month of C1D1
. Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study