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RecruitingPhase 2 / Phase 3

Open-label Study Comparing AAA817 Versus Standard of Care in the Treatment of Previously Treated PSMA-positive mCRPC Adults Who Have Disease Progressed on or After [177Lu]Lu-PSMA Targeted Therapy

PSMAcTION: A Phase II/III, Open-label, International, Multicenter, Randomized Study of AAA817 Versus Standard of Care in the Treatment of Adult Participants With PSMA Positive Metastatic Castration-resistant Prostate Cancer Who Progressed on or After [177Lu]Lu-PSMA Targeted Therapy

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 100 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 study compares AAA817, an experimental treatment, with standard care chosen by the study doctor. It is for adults with PSMA-positive prostate cancer that has spread and grows despite very low testosterone levels. Their cancer must have gotten worse during or after lutetium-177 PSMA treatment, after prior hormone-blocking medicine and taxane chemotherapy.

This is a Phase II/III study. Patient population is adult participants with PSMA-positive mCRPC who had treatments with androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy and progressed on or after \[177Lu\]Lu-PSMA targeted therapy. Treatment of interest: the investigational treatment is AAA817 regardless of subsequent anti-neoplastic treatment. The control treatment is investigator's choice of Standard of Care, regardless of subsequent anti-neoplastic treatment

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

Eligibility

Who can join

  • Age 18 or older.
  • Able to do daily self-care and be out of bed or a chair for at least half the waking day.
  • Prostate adenocarcinoma, a type of prostate cancer, confirmed by tissue or cell testing.
  • A PSMA PET/CT scan shows cancer with PSMA, a protein targeted by the treatment.
  • Testosterone level below 50 ng/dL (or 1.7 nmol/L).
  • Previously received an androgen receptor pathway inhibitor (a hormone-blocking medicine) and taxane chemotherapy. Cancer got worse during or after lutetium-177 PSMA treatment.
  • At least one area where cancer has spread, seen on a CT, MRI, or bone scan within 28 days before assignment to a study group.
  • Meet the study sponsor's requirement for eGFR, a measure of how well the kidneys filter blood.

Who can't join

  • Received an experimental drug within 28 days before assignment to a study group.
  • Ever received an experimental treatment containing actinium-225.
  • Cancer has spread to the brain or spinal cord and causes symptoms, unstable nerve function, or a need for steroids to protect nerve function.
  • Current sudden kidney injury or ongoing kidney damage lasting at least 3 months.
  • Dry mouth rated grade 2 or higher on the study's side-effect scale.
  • Uncontrolled high blood pressure, heart attack, heart-related chest pain, or heart bypass surgery within 6 months before signing consent, or significant active heart disease.
  • A history of a disease causing too many lymph cells, or another cancer within the past 2 years. Exceptions include treated basal cell skin cancer or actinic keratosis with no return for 3 months, and removed cancerous colon polyps that had not grown into nearby tissue.

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

Official eligibility criteria

Inclusion Criteria: ∙ * adults ≥ 18 years of age. * ECOG performance status of 0 to 2. * histopathological and/or cytological confirmation of adenocarcinoma of the prostate. * PSMA-positive disease as assessed by PSMA PET/CT scan using an approved PSMA imaging agent as protocol instructed, * castrate level of serum/plasma testosterone (\< 50 ng/dL or \< 1.7 nmol/L). * Prior treatments with an androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy, and progressed on or after \[177Lu\]Lu-PSMA targeted therapy. * ≥ 1 metastatic lesion that is present on screening/baseline CT, MRI, or bone scan imaging obtained ≤ 28 days prior to randomization * eGFR as requested by the sponsor Exclusion Criteria: * Any investigational agents within 28 days prior to the day of randomization. * Any 225Ac-based investigational compound used prior to the day of randomization. * Participants with a history of CNS metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity. * Concurrent acute kidney injury (renal failure developed between 48 hours to 7 days) or chronic kidney disease (at least 3 months of ongoing renal injury) * Baseline xerostomia ≥ Grade 2 by CTCAE v.5 * History of uncontrolled hypertension, myocardial infarction (MI), angina pectoris, or coronary artery bypass graft (CABG) within 6 months prior to ICF signature and/or clinically active significant cardiac disease * History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 2 years (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months, non-invasive malignant colon polyps that have been removed). Other protocol-defined inclusion/exclusion criteria may apply.

Study sites (35)

AZ

CA

CO

CT

FL

GA

IL

IN

KS

LA

MA

MO

NE

NJ

NY

OH

OR

PA

SC

TX

UT

VA

WA

WI