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Protocol NumberCAAA817B12301
NCT Number(ClinicalTrials.gov Identfier)NCT06855277
Active

2025-08-01 - 2032-12-31

Phase III

Recruiting5

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

  • Trial Applicant

    NOVARTIS (TAIWAN) CO., LTD.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/05/21

Investigators and Locations

Principal Investigator Chun-Te Wu 無
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 羅浩倫 Division of Urology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
國立臺灣大學醫學院

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator CHING-CHU LU 無
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yuh-Shyan Tsai
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Prostate Cancer

Objectives

The aim of this trial was to determine whether [225Ac]Ac-PSMA-617 (AAA817) at a dose of 10 megabecq (MBq) ± 10% for at least 2 to 6 cycles, in addition to an androgen receptor pathway inhibitor (ARPI), compared to the trial-designated standard of care (SOC) (ARPI switching or taxane-containing chemotherapy), improved radiographic progression-free survival (rPFS) as assessed by a blinded independent central evaluation committee (BICR). The trial participants were adult participants with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who had previously received a different ARPI and had never received taxane-containing chemotherapy or any PSMA-targeted precision radiotherapy in their mCRPC state. Because a third group was included who received AAA817 monotherapy, the contribution of different components (CoC) could be assessed, which helps to evaluate the contribution of AAA817 and ARPI in the AAA817+ARPI combination group.

Test Drug

Injectable

Active Ingredient

Abiraterone Acetate
CABAZITAXEL
AAA617
[ 225 Ac]Ac-PSMA-617

Dosage Form

270

Dosage

250mg
20 mg/ml
1000 MBq/mL
1 MBq/mL

Endpoints

rPFS is defined as the time elapsed from the date of randomization to the date of first recorded progression of radiographic disease or death from any cause, as assessed by the Blinded Independent Central Evaluation Committee (BICR) using standard imaging and the revised RECIST version 1.1 of the Prostate Cancer Working Group 3 (PCWG3), whichever occurs first.

Inclution Criteria

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 who have received taxane-based chemotherapy in mHSPC setting are eligible if they are deemed appropriate for chemotherapy, ARPI change or AAA617 as the next line of therapy in the opinion of the Investigator. Note: Participants who have received taxane-based chemotherapy for mCRPC are excluded.
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).

Participants with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer, as per local testing, may be enrolled if they had prior exposure to PARPi.

Exclusion Criteria

Key Exclusion Criteria:

Previous anti-cancer treatment with any approved or investigational radiopharmaceuticals (for example, [177Lu]Lu-PSMA, [177Lu]-DOTA, or Radium- 223.)
Previous treatment with any external beam radiotherapy including hemi-body radiation within 6 weeks of randomization (within 2 weeks for radiotherapy of localized metastases).

Any prior PARP inhibitor or other systemic anticancer therapy administered for metastatic castration-resistant prostate cancer (mCRPC). Any other approved or investigational systemic therapy (including chemotherapy, immunotherapy, biologics, or monoclonal antibodies) is prohibited within 28 days or 5 half-lives (whichever is shorter) before randomization.

The Estimated Number of Participants

  • Taiwan

    32 participants

  • Global

    940 participants

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