Prostate CancerPhase 1SatisfACtionNCT05983198
Phase I/II Study of [225Ac]Ac-PSMA-R2 in PSMA-positive Prostate Cancer, With/Without Prior 177Lu-PSMA RLT
A Phase 1 study testing 225Ac-PSMA-R2, 68Ga-PSMA-R2 and 68Ga-PSMA-11 in people with Prostate Cancer, run by Novartis Pharmaceuticals at 9 sites in 4 countries.
Trial summary
The purpose of this study is to learn if the study drug, [225Ac]Ac-PSMA-R2, is safe and tolerable, and has anti-tumor activity in treated patients. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 225Ac-PSMA-R2, 68Ga-PSMA-R2 and 68Ga-PSMA-11
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 7 Nov 2023to 4 Mar 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
France6 sites
Novartis Investigative Site
Clermont-Ferrand, 63011
Novartis Investigative Site
Dijon, Cote D Or, 21034
Novartis Investigative Site
Lyon, 69373
Novartis Investigative Site
Nantes, 44093
Novartis Investigative Site
Saint-Herblain, 44805
Novartis Investigative Site
Vandœuvre-lès-Nancy, 54511
Australia1 site
Novartis Investigative Site
Darlinghurst, New South Wales, 2010
About this study
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
The purpose of this study is to learn if the study drug, [225Ac]Ac-PSMA-R2, is safe and tolerable, and has anti-tumor activity in treated patients.
Read the detailed description
First in human (FIH) phase I/II study of 225Ac-PSMA-R2 in PSMA-positive metastatic prostate cancer across three groups: post-177Lu mCRPC, pre-177Lu mCRPC, and 177Lu-naïve mHSPC, evaluating Q6W/Q4W dosing. Dose escalation will enroll ~18-22 participants per group/schedule to define MTD/RDE, guided by safety, tolerability, PK/dosimetry, and preliminary anti-tumor activity, with possible expansion based on benefit-risk.
Enrollment and dosing for all participants in Group 1, Group 2, and Group 3 have been completed. Further enrollment has been halted, and no additional dose escalation cohorts or Phase 2 dose expansion cohorts will be opened; enrollment in this study is now considered complete. The decision to halt enrolment was not driven by any safety concerns identified in the study to date, but rather by a lowered expectation of benefit. Accordingly, the study will not proceed to Phase 2, and a recommended Phase 2 dose was not established
- Conditions
- Prostate Cancer
- Being tested
- 225Ac-PSMA-R2, 68Ga-PSMA-R2, 68Ga-PSMA-11
- Keywords
- 225Ac-PSMA-R2, dose limiting toxicity, DLT, Escalation with Overdose Control, EWOC, pre- and post-177Lu-PSMA-RLT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
225Ac-PSMA-R2Drug
PSMA-R2 is a ligand coupled with 225Ac an alpha emitting radionuclide
68Ga-PSMA-R2Radiation
Kit for radiopharmaceutical preparation
68Ga-PSMA-11Radiation
Also called Locametz
Kit for radiopharmaceutical preparation
| Study group | Role | What they receive |
|---|---|---|
| Group-1 (mCRPC/ post-177Lu) | Experimental | 1. Dose Escalation: All eligible participants with Metastatic Castration Resistant Prostate Cancer (mCRPC) who have received anti-cancer treatment (post-Androgen Receptor Pathway Inhibitors (ARPI), post-taxane based chemotherapy and heavily pre-treated and having already received prior 177Lu-labelled Prostate Specific Membrane Antigen (PSMA)-targeting Radioligand Therapy (RLT) will receive the starting dose of 7 Megabecquerel (MBq) of 225Ac-PSMA-R2 to determine the Maximum Tolerated Dose/Recommended Dose for Expansion (MTD/RDE) of Group 1.
2. Dose Expansion: Once RDE is determined for Group 1, participants who have previously received 177Lu-PSMA-RLT will be enrolled in Group 1 dose expansion. Receives: Drug: 225Ac-PSMA-R2; Radiation: 68Ga-PSMA-R2; Radiation: 68Ga-PSMA-11 |
| Group-2 (mCRPC/ pre-177Lu) | Experimental | 1. Dose Escalation: All eligible participants with mCRPC who have received anti-cancer treatment (post-Androgen Receptor Pathway Inhibitors (ARPI), prior taxane-based chemotherapy is not required, but have never been treated with 177Lu-labelled PSMA-targeted RLT (177Lu-labelled PSMA-targeted RLT treatment naïve) will receive the starting dose of 7 Megabecquerel (MBq) of 225Ac-PSMA-R2 to determine the Maximum Tolerated Dose/Recommended Dose for Expansion (MTD/RDE) of Group 2.
2. Dose Expansion: Once RDE is determined for Group 2, participants naïve to 177Lu-labelled PSMA-targeted Radioligand Therapy (RLT) will be enrolled in Group 2 dose expansion. Receives: Drug: 225Ac-PSMA-R2; Radiation: 68Ga-PSMA-R2; Radiation: 68Ga-PSMA-11 |
| Group 3 (mHSPC/ pre-177Lu) | Experimental | 1. Dose Escalation: All eligible participants with mHSPC (177Lu-labelled PSMA-targeted RLT treatment naïve), who are treatment naive or minimally treated with a) luteinizing hormone-releasing hormone (LHRH) agonist/antagonists or bilateral orchiectomy with or without first generation antiandrogen (e.g. bicalutamide, flutamide) b) CYP17 inhibitor or ARDT exposure. Patient in this group will start treatment with 225Ac-PSMA-R2 after group 1 and group 2 patients.
2. Dose Expansion: Once RDE is determined for Group 3, participants will be enrolled in Group 3 dose expansion. Receives: Drug: 225Ac-PSMA-R2; Radiation: 68Ga-PSMA-R2; Radiation: 68Ga-PSMA-11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I Dose Escalation: Incidence and severity of DLTs during the DLT observation period
To determine the Recommended Dose for Expansion (RDE) and corresponding regimen for 225Ac-PSMA-R2 monotherapy in PSMA-positive in:
- Group-1 (mCRPC): Participants previously treated with 177Lu-labelled PSMA-targeted RLT (post-177Lu).
- Group-2 (mCRPC): Participants not treated previously with 177Lu-labelled PSMA-targeted RLT (pre-177Lu).
- Group-3 (mHSPC): Participants not treated previously with 177Lu-labelled PSMA-targeted RLT (pre-177Lu).
Measured: Up to 6 weeks after the first 225Ac-PSMA-R2 dose administration
Phase I Dose Escalation: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) by group and frequency schedule
The distribution of adverse events will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.
Measured: From date of the first administration of 225Ac-PSMA-R2 till 30 days safety follow-up, assessed up to approximately 15 months
Phase I Dose Escalation: Tolerability
Frequency of dose interruptions, reductions, discontinuations, and dose intensity by group.
Measured: Up to 6 weeks after the first 225AC-PSMA-R2 dose administration
Phase ll Dose Expansion: Overall Response Rate (ORR)
Overall Response Rate (ORR) is defined as the proportion of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR) in soft tissue according to Prostate Cancer Working Group 3 (PCWG3) -modified RECIST v1.1 in absence of bone progression (as per PCWG3).
Measured: From date of the first administration of 225Ac-PSMA-R2 until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 15 months
Secondary outcomes (14)
Phase I Dose Escalation: Incidence and severity of AEs and serious adverse events (SAEs)
Analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.
Measured: Up to 6 months after the last 225Ac-PSMA-R2 dose administration
Phase ll: Dose Expansion: Incidence and severity of AEs and serious adverse events (SAEs)
Analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.
Measured: Assessed up to approximately 15 months.
Phase I Dose Escalation & Dose Expansion: Frequency of dose interruptions, reductions, discontinuations, and dose intensity by treatment.
Tolerability of study drug will be assessed by summarizing the number of and the reasons for dose delays and dose reductions. Dose intensity will also be tabulated by treatment group.
Measured: At day 1 of each cycle (1 cycle = up to 6 weeks)
Phase I Dose Escalation: Overall Response Rate (ORR)
Overall Response Rate (ORR) is defined as the proportion of participants with best overall response (BOR) of complete response (CR) or partial response (PR) in soft tissue.
Measured: Assessed up to approximately 15 months.
Phase I Dose Escalation & Phase II Dose Expansion: Disease Control Rate (DCR)
Disease control rate (DCR) is defined as the proportion of participants with confirmed best overall response (BOR) of complete response (CR), partial response (PR) or stable disease (SD).
Measured: Assessed up to approximately 15 months.
Phase I Dose Escalation & Phase II Dose Expansion: Best Overall Response (BOR)
Best Overall Response (BOR) is defined as the best response recorded from the start of the treatment until disease progression.
Measured: Assessed up to approximately 15 months.
Phase I Dose Escalation & Phase II Dose Expansion: radiographic Progression Free Survival (rPFS)
Radiographic progression free survival (rPFS) is defined as the time (in months) from the date of the first administration of 225Ac-PSMA-R2 to the date of radiographic progression as outlined in PCWG3 modified RECIST 1.1 or death due to any cause.
Measured: Assessed up to approximately 15 months.
Phase I Dose Escalation & Phase II Dose Expansion: Overall Survival (OS)
Overall survival (OS) is defined as the time (in months) from the date of the first administration of 225Ac-PSMA-R2 to the date of death due to any cause.
Measured: Assessed up to approximately 15 months.
Phase I Dose Escalation & Phase II Dose Expansion: Duration of Response (DoR)
Duration of response (DOR) is defined as the time (in months) from the date of the first documented response (CR or PR) to the date of first documented progression.
Measured: Assessed up to approximately 15 months.
Phase I Dose Escalation & Phase II Dose Expansion: Time to first Symptomatic Skeletal Event (SSE)
Time to a first symptomatic skeletal event (SSE) is defined as the time (in months) from the first administration of 225Ac-PSMA-R2 to the date of SSE or death due to any cause.
Measured: Assessed up to approximately 15 months.
Phase I Dose Escalation & Phase II Dose Expansion: Percentage of Participants with Biochemical Response by ALP and LDH
Biochemical responses by Alkaline Phosphatase (ALP) and Lactate Dehydrogenase (LDH) will be measured as best percentage change from baseline
Measured: Assessed up to approximately 15 months.
Phase I Dose Escalation and Phase II Dose Expansion: Percentage of Participants with Biochemical Response by PSA
Biochemical responses as measured by Prostate Specific Antigen (PSA): PSA50 response is defined as the proportion of participants who have achieved ≥50% decrease from baseline at any time.
Measured: Assessed up to approximately 15 months.
Phase I Dose Escalation and Phase II: Dose Expansion: Pharmacokinetics characterization of 225Ac-PSMA-R2
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization.
Measured: At Cycle (C) 1 Day (D) 1 at different measurement times, and one timepoint at C1 D2, C1 D3 and C1 D4
Phase I Dose Escalation and Phase II Dose Expansion: To assess the impact of 225Ac-PSMA-R2 on participant reported outcomes
Change in heath related quality of life.
Measured: From baseline until 24 months after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start7 Nov 2023
- Primary completion4 Mar 2031 (estimated)
- Study completion4 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05983198
- Sponsor's protocol ID
- CAAA802A12101
- Other IDs
- 2021-003478-30
- Acronym
- SatisfACtion
- Status last verified
- Sep 2026
- First submitted
- 24 Jul 2023
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05983198
- Acronym / sponsor ID
- SatisfACtion / CAAA802A12101
- Conditions
- Prostate Cancer
- Keywords
- 225Ac-PSMA-R2, dose limiting toxicity, DLT, Escalation with Overdose Control, EWOC, pre- and post-177Lu-PSMA-RLT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 4 Mar 2031 (estimated)
- Study completion
- 4 Mar 2031 (estimated)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn if the study drug, [225Ac]Ac-PSMA-R2, is safe and tolerable, and has anti-tumor activity in treated patients.
Detailed description
First in human (FIH) phase I/II study of 225Ac-PSMA-R2 in PSMA-positive metastatic prostate cancer across three groups: post-177Lu mCRPC, pre-177Lu mCRPC, and 177Lu-naïve mHSPC, evaluating Q6W/Q4W dosing. Dose escalation will enroll ~18-22 participants per group/schedule to define MTD/RDE, guided by safety, tolerability, PK/dosimetry, and preliminary anti-tumor activity, with possible expansion based on benefit-risk.
Enrollment and dosing for all participants in Group 1, Group 2, and Group 3 have been completed. Further enrollment has been halted, and no additional dose escalation cohorts or Phase 2 dose expansion cohorts will be opened; enrollment in this study is now considered complete. The decision to halt enrolment was not driven by any safety concerns identified in the study to date, but rather by a lowered expectation of benefit. Accordingly, the study will not proceed to Phase 2, and a recommended Phase 2 dose was not established
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group-1 (mCRPC/ post-177Lu) | Experimental | Drug: 225Ac-PSMA-R2, Radiation: 68Ga-PSMA-R2, Radiation: 68Ga-PSMA-111. Dose Escalation: All eligible participants with Metastatic Castration Resistant Prostate Cancer (mCRPC) who have received anti-cancer treatment (post-Androgen Receptor Pathway Inhibitors (ARPI), post-taxane based chemotherapy and heavily pre-treated and having already received prior 177Lu-labelled Prostate Specific Membrane Antigen (PSMA)-targeting Radioligand Therapy (RLT) will receive the starting dose of 7 Megabecquerel (MBq) of 225Ac-PSMA-R2 to determine the Maximum Tolerated Dose/Recommended Dose for Expansion (MTD/RDE) of Group 1. 2. Dose Expansion: Once RDE is determined for Group 1, participants who have previously received 177Lu-PSMA-RLT will be enrolled in Group 1 dose expansion. |
| Group-2 (mCRPC/ pre-177Lu) | Experimental | Drug: 225Ac-PSMA-R2, Radiation: 68Ga-PSMA-R2, Radiation: 68Ga-PSMA-111. Dose Escalation: All eligible participants with mCRPC who have received anti-cancer treatment (post-Androgen Receptor Pathway Inhibitors (ARPI), prior taxane-based chemotherapy is not required, but have never been treated with 177Lu-labelled PSMA-targeted RLT (177Lu-labelled PSMA-targeted RLT treatment naïve) will receive the starting dose of 7 Megabecquerel (MBq) of 225Ac-PSMA-R2 to determine the Maximum Tolerated Dose/Recommended Dose for Expansion (MTD/RDE) of Group 2. 2. Dose Expansion: Once RDE is determined for Group 2, participants naïve to 177Lu-labelled PSMA-targeted Radioligand Therapy (RLT) will be enrolled in Group 2 dose expansion. |
| Group 3 (mHSPC/ pre-177Lu) | Experimental | Drug: 225Ac-PSMA-R2, Radiation: 68Ga-PSMA-R2, Radiation: 68Ga-PSMA-111. Dose Escalation: All eligible participants with mHSPC (177Lu-labelled PSMA-targeted RLT treatment naïve), who are treatment naive or minimally treated with a) luteinizing hormone-releasing hormone (LHRH) agonist/antagonists or bilateral orchiectomy with or without first generation antiandrogen (e.g. bicalutamide, flutamide) b) CYP17 inhibitor or ARDT exposure. Patient in this group will start treatment with 225Ac-PSMA-R2 after group 1 and group 2 patients. 2. Dose Expansion: Once RDE is determined for Group 3, participants will be enrolled in Group 3 dose expansion. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 225Ac-PSMA-R2PSMA-R2 is a ligand coupled with 225Ac an alpha emitting radionuclide | Drug | Group 3 (mHSPC/ pre-177Lu), Group-1 (mCRPC/ post-177Lu), Group-2 (mCRPC/ pre-177Lu) |
| 68Ga-PSMA-R2Kit for radiopharmaceutical preparation | Radiation | Group 3 (mHSPC/ pre-177Lu), Group-1 (mCRPC/ post-177Lu), Group-2 (mCRPC/ pre-177Lu) |
| 68Ga-PSMA-11Also: LocametzKit for radiopharmaceutical preparation | Radiation | Group 3 (mHSPC/ pre-177Lu), Group-1 (mCRPC/ post-177Lu), Group-2 (mCRPC/ pre-177Lu) |
Primary outcome
Phase I Dose Escalation: Incidence and severity of DLTs during the DLT observation period
Time frame: Up to 6 weeks after the first 225Ac-PSMA-R2 dose administration
To determine the Recommended Dose for Expansion (RDE) and corresponding regimen for 225Ac-PSMA-R2 monotherapy in PSMA-positive in: * Group-1 (mCRPC): Participants previously treated with 177Lu-labelled PSMA-targeted RLT (post-177Lu). * Group-2 (mCRPC): Participants not treated previously with 177Lu-labelled PSMA-targeted RLT (pre-177Lu). * Group-3 (mHSPC): Participants not treated previously with 177Lu-labelled PSMA-targeted RLT (pre-177Lu).
Phase I Dose Escalation: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) by group and frequency schedule
Time frame: From date of the first administration of 225Ac-PSMA-R2 till 30 days safety follow-up, assessed up to approximately 15 months
The distribution of adverse events will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.
Phase I Dose Escalation: Tolerability
Time frame: Up to 6 weeks after the first 225AC-PSMA-R2 dose administration
Frequency of dose interruptions, reductions, discontinuations, and dose intensity by group.
Phase ll Dose Expansion: Overall Response Rate (ORR)
Time frame: From date of the first administration of 225Ac-PSMA-R2 until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 15 months
Overall Response Rate (ORR) is defined as the proportion of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR) in soft tissue according to Prostate Cancer Working Group 3 (PCWG3) -modified RECIST v1.1 in absence of bone progression (as per PCWG3).
14 secondary outcomes
Phase I Dose Escalation: Incidence and severity of AEs and serious adverse events (SAEs)
Time frame: Up to 6 months after the last 225Ac-PSMA-R2 dose administration
Phase ll: Dose Expansion: Incidence and severity of AEs and serious adverse events (SAEs)
Time frame: Assessed up to approximately 15 months.
Phase I Dose Escalation & Dose Expansion: Frequency of dose interruptions, reductions, discontinuations, and dose intensity by treatment.
Time frame: At day 1 of each cycle (1 cycle = up to 6 weeks)
Phase I Dose Escalation: Overall Response Rate (ORR)
Time frame: Assessed up to approximately 15 months.
Phase I Dose Escalation & Phase II Dose Expansion: Disease Control Rate (DCR)
Time frame: Assessed up to approximately 15 months.
Phase I Dose Escalation & Phase II Dose Expansion: Best Overall Response (BOR)
Time frame: Assessed up to approximately 15 months.
Phase I Dose Escalation & Phase II Dose Expansion: radiographic Progression Free Survival (rPFS)
Time frame: Assessed up to approximately 15 months.
Phase I Dose Escalation & Phase II Dose Expansion: Overall Survival (OS)
Time frame: Assessed up to approximately 15 months.
Phase I Dose Escalation & Phase II Dose Expansion: Duration of Response (DoR)
Time frame: Assessed up to approximately 15 months.
Phase I Dose Escalation & Phase II Dose Expansion: Time to first Symptomatic Skeletal Event (SSE)
Time frame: Assessed up to approximately 15 months.
Phase I Dose Escalation & Phase II Dose Expansion: Percentage of Participants with Biochemical Response by ALP and LDH
Time frame: Assessed up to approximately 15 months.
Phase I Dose Escalation and Phase II Dose Expansion: Percentage of Participants with Biochemical Response by PSA
Time frame: Assessed up to approximately 15 months.
Phase I Dose Escalation and Phase II: Dose Expansion: Pharmacokinetics characterization of 225Ac-PSMA-R2
Time frame: At Cycle (C) 1 Day (D) 1 at different measurement times, and one timepoint at C1 D2, C1 D3 and C1 D4
Phase I Dose Escalation and Phase II Dose Expansion: To assess the impact of 225Ac-PSMA-R2 on participant reported outcomes
Time frame: From baseline until 24 months after the end of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 225Ac-PSMA-R2, 68Ga-PSMA-R2 and 68Ga-PSMA-11 in people with Prostate Cancer, run by Novartis Pharmaceuticals at 9 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France, United States, Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I Dose Escalation: Incidence and severity of DLTs during the DLT observation period (time frame: Up to 6 weeks after the first 225Ac-PSMA-R2 dose administration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.