Trial purpose
Cancer treatment
Tumor type
Genitourinary
Age
18+
Trial acronym
SatisfACtion
Clinical summary
Summary
This trial is evaluating a treatment called 225Ac-PSMA-R2, which is a type of PSMA-targeted radioligand therapy. The ligand (PSMA-R2) directs the alpha emitting radionuclide (225Ac) to target cancer cells and deliver radiation directly into these cells.
This study contains two treatment groups (Group 1 and Group 2). Group 1 will consist of participants who have previously received 177Lu-PSMA-RLT, and Group 2 will consist of participants who have not had any treatment with 177Lu-PSMA-RLT.
Each group has a dose escalation part, and once the maximum tolerated dose (MTD) and recommended dose for expansion (RDE) is determined in each of the dose escalation parts, the study will continue with an expansion part in the respective group.
The dose escalation parts will establish the MTD/RDE of the 225Ac-PSMA-R2.
The dose expansion parts will assess the anti-tumour activity of 225Ac-PSMA-R2, as well as further assess how safe and tolerable it is.
Conditions
This trial is treating people with metastatic castration-resistant prostate cancer who have had prior treatment with androgen receptor pathway inhibitors in post-177Lu and pre-177Lu settings
Eligibility
Inclusion
- Evidence of PSMA-positive disease by 68Ga-PSMA-11 PET/CT and eligible as determined by central reading
- Documented progressive mCRPC
- Adequate organ function (bone marrow reserve, hepatic, renal)
- Prior orchiectomy or ongoing ADT and should have received prior 177Lu-PSMA-RLT (Group1 dose escalation & expansion) or never received 177Lu-PSMA-RLT (Group 2 dose escalation & expansion).
Exclusion
- Any other investigational agents within 28 days of the anticipated C1D1 of 225Ac-PSMA-R2 therapy
- Any systemic anti-cancer therapy within 28 days of the anticipated C1D1 of 225Ac-PSMA-R2 therapy
- Uncontrolled pain or incompatibility that may result in participant's lack of ability to comply with imaging procedures
- History of CNS metastases and symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression
- History of myocardial infarction, angina pectoris, or coronary artery bypass graft within 6 months prior to ICF signature and/or clinically active significant cardiac disease
- Diagnosis of other malignancies in the past three years expected to alter life expectancy or may interfere with disease assessment
Other protocol-defined inclusion/exclusion criteria may apply.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You are currently being treated on a clinical trial.
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:
Trial sponsor
Novartis Pharmaceuticals
Scientific Title
A Phase I/II, Open-label, Multi-center Study of [225Ac]Ac-PSMA-R2 in Men With Heavily Pre-treated PSMA Positive Metastatic Castration Resistant Prostate Cancer (mCRPC) With or Without Prior 177Lu-labelled PSMA-targeted Radioligand Therapy
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