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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06780670




Registration number
NCT06780670
Ethics application status
Date submitted
17/12/2024
Date registered
17/01/2025
Date last updated
4/07/2025

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 0 0
2024-512342-42-00
Secondary ID [2] 0 0
CAAA817A12201
Universal Trial Number (UTN)
Trial acronym
PSMAcTION
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Investigators choice of SoC
Treatment: Drugs - AAA817
Treatment: Drugs - AAA817
Treatment: Drugs - AAA817

Experimental: Phase II: AAA817 Dose B - AAA817 will be given for a number of cycles; a cycle = 8 weeks

Active comparator: Phase III: Investigator's choice of SoC - Participants will be given Standard of Care (SOC) treatment per Investigator's choice.

Experimental: Phase II: AAA817 Dose A - AAA817 Dose A will be given for a number of cycles: a cycle = 8 weeks

Experimental: Phase III: Recommended Phase 3 Dose of AAA817 - Rp3D of AAA817 will be given for a number of cycles; a cycle = 8 weeks


Treatment: Drugs: Investigators choice of SoC
The control treatment in Phase III is investigator's choice of SoC

Treatment: Drugs: AAA817
The investigational treatment is AAA817

Treatment: Drugs: AAA817
The investigational treatment is AAA817

Treatment: Drugs: AAA817
Investigational treatment is the Dose B of AAA817
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Biochemical response rate (Phase II)
Timepoint [1] 0 0
from date of randomization up to approximately 24 months
Primary outcome [2] 0 0
Adverse Events (AEs) and Serious Adverse Events (SAEs), and deaths - Phase II
Timepoint [2] 0 0
from day of randomization to 30 days after End of Treatment or (last AAA817 dose date + 55 days, last dose date of SoC + 30 days), whichever is later
Primary outcome [3] 0 0
Tolerability of the proposed dose of AAA817- Phase II
Timepoint [3] 0 0
From on-treatment period which start from the first dose of study treatment until 30 days post-last dose date for SoC and 55 days post last-dose for AAA817
Primary outcome [4] 0 0
Radiographic progression-free survival (rPFS)- Phase III
Timepoint [4] 0 0
from date of randomization up to approximately 24 months
Primary outcome [5] 0 0
Overall survival (OS)- Phase III
Timepoint [5] 0 0
from date of randomization up to approximately 24 months
Secondary outcome [1] 0 0
Radiographic progression-free survival (rPFS)- Phase II
Timepoint [1] 0 0
from date of randomization up to approximately 24 months
Secondary outcome [2] 0 0
Progression free survival (PFS)- Phase II
Timepoint [2] 0 0
from date of randomization up to approximately 24 months
Secondary outcome [3] 0 0
Overall response rate (ORR)- Phase II
Timepoint [3] 0 0
from date of randomization up to approximately 24 months
Secondary outcome [4] 0 0
Disease control rate (DCR)- Phase II
Timepoint [4] 0 0
from date of randomization up to approximately 24 months
Secondary outcome [5] 0 0
Overall survival (OS)- Phase II
Timepoint [5] 0 0
from date of randomization up to approximately 24 months
Secondary outcome [6] 0 0
Progression free survival (PFS) -Phase III
Timepoint [6] 0 0
from date of randomization up to approximately 24 months
Secondary outcome [7] 0 0
Overall response rate (ORR)- Phase III
Timepoint [7] 0 0
from date of randomization up to approximately 24 months
Secondary outcome [8] 0 0
Disease control rate (DCR) -Phase III
Timepoint [8] 0 0
from date of randomization up to approximately 24 months
Secondary outcome [9] 0 0
Duration of response (DoR)- Phase III
Timepoint [9] 0 0
from date of randomization up to approximately 24 months
Secondary outcome [10] 0 0
Time to first radiographic soft tissue progression (TTSTP)- Phase III
Timepoint [10] 0 0
from date of randomization up to approximately 24 months
Secondary outcome [11] 0 0
First symptomatic skeletal event (TTSSE)_Phase III
Timepoint [11] 0 0
from date of randomization up to approximately 24 months
Secondary outcome [12] 0 0
Prostate specific antigen (PSA) response -Phase III
Timepoint [12] 0 0
from date of randomization up to approximately 24 months
Secondary outcome [13] 0 0
Patient reported disease related symptoms and health-related quality of life (HRQoL): Phase III
Timepoint [13] 0 0
from date of randomization up to approximately 24 months
Secondary outcome [14] 0 0
Time to worsening on the Worst Pain: Phase III
Timepoint [14] 0 0
from date of randomization up to approximately 24 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
100 Years
Sex
Males
Can healthy volunteers participate?
No
Key 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 5 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/02/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
3/06/2033
Actual
Sample size
Target
432
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Novartis Investigative Site - Darlinghurst
Recruitment hospital [2] 0 0
Novartis Investigative Site - Herston
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Beijing
Country [2] 0 0
Israel
State/province [2] 0 0
Tel Aviv
Country [3] 0 0
Singapore
State/province [3] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
1-888-669-6682
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06780670