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Clinical trial No longer in our active list Phase1; Phase2 Interventional Ages 18 to 100 Men only

Testing a new drug for prostate cancer treatment

Official title: SatisfACtion: Phase I/II, Open-label, Multi-center Study of [225Ac]Ac-PSMA-R2 in Men With mHSPC and Heavily Pre-treated PSMA-positive mCRPC, With/Without Prior 177Lu-labelled PSMA-targeted Radioligand Therapy

Run by Novartis · NCT05983198 · Data updated 2026-05-14

This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.

This study is testing a new drug for prostate cancer to see if it can help adults whose cancer has not responded to other treatments.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years to 100 Years
SexMen only
Enrollment70 (estimated)
SponsorNovartis
Industry-sponsored
Locations9 sites (Darlinghurst, New South Wales and 8 other locations)
Trial IDNCT05983198 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults with PSMA-positive metastatic hormone-sensitive or castration-resistant prostate cancer who have received prior anti-cancer treatment.

Probably not a fit

Patients with uncontrolled pain, recent history of significant cardiac events, or those currently receiving other investigational agents may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, phase I/II study evaluates the safety, tolerability, and anti-tumor activity of the drug [225Ac]Ac-PSMA-R2 in adult patients with metastatic hormone-sensitive prostate cancer and metastatic castration-resistant prostate cancer. Participants will be grouped based on their prior treatment history and will undergo dose escalation to determine the maximum tolerated dose. The study aims to assess the drug's effectiveness in patients who have shown progression despite previous treatments and have a positive PSMA PET scan.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced prostate cancer who have limited treatment choices.

How similar studies have gone: While this approach is novel in its specific application, similar studies using targeted radioligand therapies have shown promising results in treating prostate cancer.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* Evidence of PSMA-positive disease by 68Ga-PSMA-11 PET/CT and eligible as determined by central reading
* Documented progressive mCRPC or mHSPC
* Adequate organ function
* 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 and Group 3 dose escalation \& expansion).

Key Exclusion Criteria:

* 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.

Where it's running

  • Novartis Investigative Site
    Darlinghurst, New South Wales, Australia     Recruiting
  • Novartis Investigative Site
    Montreal, Quebec, Canada     Recruiting
  • Novartis Investigative Site
    Montreal, Quebec, Canada     Recruiting
  • Novartis Investigative Site
    Dijon, Cote D Or, France     Recruiting
  • Novartis Investigative Site
    Clermont-Ferrand, France     Recruiting
  • Novartis Investigative Site
    Lyon, France     Recruiting
Show 3 more locations
  • Novartis Investigative Site
    Nantes Cedex 1, France     Recruiting
  • Novartis Investigative Site
    Saint Herblain, France     Recruiting
  • Novartis Investigative Site
    Vandoeuvre Les Nancy, France     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.