RecruitingPhase 1

Phase I Study of 225Ac-J591 Plus 177Lu-PSMA Small Molecule for Progressive Metastatic Castration Resistant Prostate Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 99 Years
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This early study tests 225Ac-J591 together with 177Lu-PSMA, two drugs that deliver radiation to prostate cancer cells. It aims to find the highest dose that can be given safely. It is for adults whose prostate cancer has spread and is getting worse despite very low testosterone levels.

This is a phase I dose-escalation study of 225Ac-J591 administered together with 177Lu-PSMA small molecule. Both drugs are designed to deliver radiation to prostate cancer cells; they are known as radionuclide conjugates (radiation linked to antibodies/molecules that recognize prostate cancer cells). This phase of the study (phase I) will determine the highest dose of the study intervention that can be safely given.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be older than 18 and have prostate adenocarcinoma, a type of cancer confirmed by a tissue or cell test.
  • Have cancer that has spread and is getting worse despite low testosterone. This must show through rising PSA blood levels, growth on scans, or new cancer spots in bones.
  • Be able to care for yourself and be out of bed or a chair for at least half of your waking hours.
  • Have testosterone below 50 ng/dL. Keep taking medicine to lower testosterone unless both testicles were removed.
  • Have had at least one hormone-blocking drug, such as enzalutamide or abiraterone.
  • Have had taxane chemotherapy, been told by your doctor that it is not suitable, or chosen not to receive it.
  • Meet the study’s blood count, kidney, and liver test limits.
  • Be able to understand the study and willing to sign a consent form.

Who can't join

  • Recent use of an experimental drug or placement of an experimental device, or current enrollment in another experimental cancer drug or device study. Timing limits include 4 weeks and, for drugs, how long they stay in the body.
  • Past treatment with certain radioactive drugs that target bones, or radium-223 within the past 90 days. Prior PSMA-targeted radiation treatment is not allowed in the previously untreated group; the prior 177Lu-PSMA group must not have had side effects that limited dosing.
  • Active cancer in the brain or its lining; a deep vein or lung blood clot within the past month; or another serious illness that could affect study safety or results.
  • Radiation treatment for prostate cancer within 4 weeks before study treatment, or use of a PARP inhibitor cancer drug for more than 2 weeks.
  • Starting bone-strengthening drugs called bisphosphonates or denosumab during the early safety-check period. A stable dose started at least 4 weeks before treatment may continue.
  • Unwilling to use study-approved birth control if a partner could become pregnant, during the study and for at least 140 days after the last dose.
  • Another active cancer, except non-melanoma skin cancer, or a history of myelodysplastic syndrome, a disorder of blood-forming bone marrow. A treated cancer is not considered active if the doctor estimates its chance of returning is below 30%.
  • A bone scan called a “superscan,” with cancer spots that blend together and no scan tracer showing in the urine, as judged by the study doctor.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 * Have serum testosterone \< 50 ng/dL. Subjects must continue primary androgen deprivation with an LHRH/GnRH 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/uL, 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: \<1.5 x ULN in the absence of liver metastases; \<3 x 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 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 Treatment visit # 1(Day 1) or current enrollment in investigational oncology drug or device study * Prior systemic beta-emitting bone-seeking radioisotopes. Prior radium-223 is allowed provided at least 90 days have lapsed since last dose * For the prior PSMA-TRT-naive cohort, prior PSMA-targeted radionuclide therapy is not allowed (prior PSMA-targeted isotopes used for imaging/diagnostic purposes are allowed, as is prior PSMA-targeted therapy that does not involve therapeutic radionuclides); For the 177Lu-PSMA small molecule exposed cohort, no dose limiting toxicity may have been observed during/after therapy with prior treatment and all other entry criteria must be met * Known active brain or leptomeningeal metastases * History of deep vein thrombosis and/or pulmonary embolus within 1 month of Treatment visit #1 * 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 * Radiation therapy for treatment of PC ≤4 weeks of Treatment visit #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 at least 140 days 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 myelodysplastic syndrome * Bone scan with confluent lesions and lack of urinary tracer consistent with a "superscan" as determined by the investigator * Prior exposure to PARP inhibitor \> 2 weeks

Study sites (2)

NY