ClinTrial Refer

Trial Acronym
AcTFirst

Registration Number
NCT06855277

Scientific Title
A Phase III, Open-label, Multi-center, Randomized Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive Metastatic Castration Resistant Prostate Cancer

The purpose of this study is to determine whether [225Ac]Ac-PSMA-617 (AAA817), given for up to 6 cycles at a dose of 10 Megabecquerel (MBq) +/- 10%, plus androgen receptor pathway inhibitor (ARPI), improves the radiographic progression free survival (rPFS) compared to investigator's choice of standard of care (SOC) (ARPI change or taxane-based chemotherapy) in adult participants with PSMA-positive metastatic castration resistant prostate cancer (mCRPC) treated with another ARPI as last treatment and who have not been exposed to a taxane-containing chemotherapy in the mCRPC setting nor have received any prior PSMA-targeting radioligand therapy.

Key Inclusion Criteria:

Signed informed consent must be obtained prior to participation in the study.
Participants must be adults ≥ 18 years of age.
Participants must have an ECOG performance status of 0 to 2.
Participants must have histological, and/or cytological confirmation of adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are not eligible.
Participants must not have received taxane-based chemotherapy in mCRPC setting (allowed in mHSPC setting).
Participants must have PSMA-PET positive disease using a PSMA imaging agent that is approved as per protocol.
Participant must have been diagnosed with mCRPC with documented progressive disease while on treatment with ARPI in mHSPC or earlier setting as their last treatment (and did not progress on more than one ARPI).

Key Exclusion Criteria:

Previous treatment with any approved or investigational RLT, approved or investigational radioisotopes
Previous treatment with any conventional external beam radiotherapy including hemi-body radiation within 6 weeks of randomization (within 2 weeks for radiotherapy of localized metastases).
Participants with known or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer.
Any approved or investigational agents/systemic anti-cancer therapy (e.g. other chemotherapy, investigational therapy, immunotherapy or biological therapy including monoclonal antibodies) within 28 days (or 5 times the half-life of that therapy whichever is longer) of the anticipated day C1D1.
Diagnosed with other active malignancies that are expected to alter life expectancy or may interfere with disease assessment.
Other protocol-defined inclusion/exclusion criteria may apply.

Trial Location Name

Address

Status

Royal Adelaide Hospital (Oncology)

Port Rd, Adelaide SA 5000, Australia

Recruiting

Primary Contact : Jes Logan, Jesikah.Logan@sa.gov.au , 08 7074 2341

Secondary Contact : Herson Rivas, herson.rivas@sa.gov.au , 08 7074 2345

Novartis Pharmaceuticals

Website URL

Link Name

Link URL

ANZCTR

http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=NCT06855277

Clinicaltrials.gov

https://clinicaltrials.gov/ct2/show/NCT06855277

Secondary IDs
2024-512340-32-00CAAA817B12301

Study Type
Interventional

Intervention Code
Not applicable

Phase
Phase 2

Minimum Age
18

Maximum Age
100

Date Registered
26/02/2025

Date Closed
N/A

Status
Open

Enrolment Type
By Specialist and/or Surgeon Referral

Mutation Status and Biomarker
Any or not stated

Is it a Cohort Trial?
No

Is this a Tele-Trial?
No

Can healthy volunteer participate?
No

Discipline

Health Condition

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