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Prostate CancerPhase 1NCT03276572

Phase I Trial of 225Ac-J591 in Patients With mCRPC

A Phase 1 study testing 225Ac-J591 in people with Prostate Cancer, run by Weill Medical College of Cornell University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open-label, single-center Phase I dose escalation study designed to determine the dose-limiting toxicity (DLT) and the maximum tolerated dose (MTD) of 225Ac-J591 in a single dose regimen. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
225Ac-J591
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
2 sitesUnited States
Study dates
10 Oct 2017to 1 Sep 2023
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed adenocarcinoma of prostate
  • Documented progressive metastatic CRPC based on Prostate Cancer Working Group 3 (PCWG3) criteria, which includes at least one of the following criteria:
  • PSA progression
  • Objective radiographic progression in soft tissue
  • New bone lesions
  • ECOG performance status of 0-2
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  • Have serum testosterone < 50 ng/dL. Subjects must continue primary androgen deprivation with an LHRH analogue (agonist/antagonist) if they have not undergone bilateral orchiectomy.
  • Have previously been treated with at least one of the following:
  • Androgen receptor signaling inhibitor (such as enzalutamide)
  • CYP 17 inhibitor (such as abiraterone acetate)
  • Have previously received taxane chemotherapy, been determined to be ineligible for taxane chemotherapy by their physician, or refused taxane chemotherapy.
  • Age > 18 years
  • Patients must have normal organ and marrow function as defined below:
  • Absolute neutrophil count >2,000 cells/mm3
  • Hemoglobin ≥9 g/dL
  • Platelet count >150,000 x 109/microliter
  • Serum creatinine <1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 mL/min/1.73 m2 by Cockcroft-Gault
  • Serum total bilirubin <1.5 x ULN (unless due to Gilbert's syndrome in which case direct bilirubin must be normal
  • Serum AST and ALT <3 x ULN in absence of liver metastases; <5x ULN if due to liver metastases (in both circumstances, bilirubin must meet entry criteria)
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Implantation of investigational medical device ≤4 weeks of Cycle 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
  • Prior systemic beta-emitting bone-seeking radioisotopes
  • 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
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  • Radiation therapy for treatment of PC ≤4 weeks of Day 1 Cycle 1
  • Patients on stable dose of bisphosphonates or Denosumab, which have been started no less than 4 weeks prior to treatment start, may continue on this medication, however patients are not allowed to initiate bisphosphonate/Denosumab therapy during the DLT-assessment period of the study.
  • Having partners of childbearing potential and not willing to use a method of birth control deemed acceptable by the principle investigator and chairperson during the study and for 1 month after last study drug administration
  • Currently active other malignancy other than non-melanoma skin cancer. Patients are considered not to have "currently active" malignancy if they have completed any necessary therapy and are considered by their physician to be at less than 30% risk of relapse.
  • Known history of known myelodysplastic syndrome

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Tulane Cancer Center Clinic

    New Orleans, Louisiana, 70112

  • Weill Cornell Medical College

    New York, New York, 10065

Other trials in United States

About this study

Official title: Phase I Dose-Escalation Trial of 225Ac-J591 in Patients With Metastatic Castration-Resistant Prostate Cancer

This is an open-label, single-center Phase I dose escalation study designed to determine the dose-limiting toxicity (DLT) and the maximum tolerated dose (MTD) of 225Ac-J591 in a single dose regimen.

Read the detailed description

This clinical trial is for men with advanced prostate cancer. The purpose of this study is to find the highest dose level of the study drug, 225Ac-J591 that can be given without severe side effects. The research study is being done because the standard treatments for prostate cancer that has spread beyond the prostate gland are intended to minimize the adverse effects of the disease. These treatments, however, are not curative. Patients who choose to participate in this study will have a screening visit to determine whether or not they are eligible to participate in the study. The treatment phase is comprised of 8 visits over approximately 12 weeks. The study medication is called 225Ac-J591, and participants will receive an infusion of the study drug on the Treatment visit of the study. Upon completion of investigational treatment with single dose of 225Ac-J591, subjects will undergo 68Ga-PSMA-HBED-CC injection and same day PET/CT at the end of study visit to document treatment response. Subsequently survival data and additional treatment(s) information will be captured from their routine Standard of care (SOC) visits.During the other study visits, participants will undergo routine tests and procedures, such as physical examinations, and routine blood tests. Some blood tests will be done for research purposes only. After completion of therapy, participants may be contacted on a periodic basis to see how they are doing.

Key eligibility:

  • Open to men age 18 and older.
  • Diagnosis of progressive metastatic prostate cancer
  • Have been previously treated for their disease with particular types of therapy.
Conditions
Prostate Cancer
Being tested
225Ac-J591
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 225Ac-J591Drug

    Also called 68Ga-PSMA-HBED-CC injection for PET/CT Scan on day 1 and at end of study

    225Ac-J591 (13.3 KBq/Kg - 93.3 KBq/Kg or 0.36 uCi/Kg - 2.52 uCi/Kg) on day 1

Study groups in NCT03276572
Study groupRoleWhat they receive
All SubjectsExperimentalA single dose of 225Ac-J591 will be given to subjects with documented progressive metastatic CRPC.
Receives: Drug: 225Ac-J591

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Subjects With Dose Limiting Toxicities (DLT)

    Count of participants will be measured by the recommended phase II dose in utilizing the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for DLTs.

    Measured: Assessed from start of treatment to up to 8 weeks after first study drug administration.

  2. Number of Subjects Who Reached Maximum Tolerated Dose (MTD)

    The MTD is the highest dose amongst the different dose-level cohorts in this study at which no more than 2 (33%) of the subjects in a cohort experience DLT.

    Measured: Assessed from start of treatment to up to 8 weeks after first study drug administration.

Secondary outcomes (4)

  1. Number of Subjects With Prostate Specific Antigen (PSA) Response

    PSA will be analyzed through blood specimen collection

    Measured: PSA was assessed at screening, and up to 6 months after first treatment with study drug.

  2. Number of Subjects With Circulating Tumor Cells (CTC) Response

    CTCs will be analyzed through blood specimen collection via CellSearch methodology lab testing

    Measured: CTC was assessed at screening and 12 weeks after starting study drug.

  3. Number of Subjects With Radiographic (Imaging) Response

    Radiographic response rate by Response evaluation criteria in solid tumors (RECIST) criteria with Prostate Cancer Working Group 3 (PCWG3) modifications

    Measured: Response were assessed for patients throughout their duration on the study, up to 3 years.

  4. Progression Free Survival (PFS)

    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Measured: From the start of treatment to progression, up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2017
  2. Study start10 Oct 2017
  3. Primary completion7 Jan 2021
  4. Study completion1 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03276572
Sponsor's protocol ID
1706018281
Other IDs
7R01CA207645-03
Status last verified
May 2024
First submitted
3 Aug 2017
Last updated
13 Jun 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Stangl-Kremser J, Ricaurte-Fajardo A, Huicochea Castellanos S, Martinez-Fundichely A, Sun M, Osborne JR, Nauseef JT, Tagawa ST, Bander NH. Baseline Imaging Derived Factors of Response Following [225Ac]Ac-J591 Therapy in Metastatic Castration-Resistant Prostate Cancer: A Lesion Level Analysis. Prostate. 2025 Apr;85(5):502-509. doi: 10.1002/pros.24853. Epub 2025 Jan 23.

    PubMed 39853781

  • Tagawa ST, Thomas C, Sartor AO, Sun M, Stangl-Kremser J, Bissassar M, Vallabhajosula S, Huicochea Castellanos S, Nauseef JT, Sternberg CN, Molina A, Ballman K, Nanus DM, Osborne JR, Bander NH. Prostate-Specific Membrane Antigen-Targeting Alpha Emitter via Antibody Delivery for Metastatic Castration-Resistant Prostate Cancer: A Phase I Dose-Escalation Study of 225Ac-J591. J Clin Oncol. 2024 Mar 1;42(7):842-851. doi: 10.1200/JCO.23.00573. Epub 2023 Nov 3.

    PubMed 37922438

  • Vlachostergios PJ, Niaz MJ, Skafida M, Mosallaie SA, Thomas C, Christos PJ, Osborne JR, Molina AM, Nanus DM, Bander NH, Tagawa ST. Imaging expression of prostate-specific membrane antigen and response to PSMA-targeted beta-emitting radionuclide therapies in metastatic castration-resistant prostate cancer. Prostate. 2021 Apr;81(5):279-285. doi: 10.1002/pros.24104. Epub 2021 Jan 19.

    PubMed 33465252

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 225Ac-J591 in people with Prostate Cancer, run by Weill Medical College of Cornell University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Dose Limiting Toxicities (DLT) (time frame: Assessed from start of treatment to up to 8 weeks after first study drug administration.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03276572, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.

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