Testing a new drug for prostate cancer treatment
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
PHASE1; PHASE2 · Novartis · NCT05983198
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
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Male |
| Sponsor | Novartis (industry) |
| Locations | 9 sites (Darlinghurst, New South Wales and 8 other locations) |
| Trial ID | NCT05983198 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults with PSMA-positive metastatic hormone-sensitive or castration-resistant prostate cancer who have received prior anti-cancer treatment.
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.
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 performed: While this approach is novel in its specific application, similar studies using targeted radioligand therapies have shown promising results in treating prostate cancer.
Eligibility criteria
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 this trial is running
Darlinghurst, New South Wales and 8 other locations
- 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)
- 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
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: 1-888-669-6682
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer, 225Ac-PSMA-R2, dose limiting toxicity, DLT, Escalation with Overdose Control, EWOC, pre- and post-177Lu-PSMA-RLT