Clinical Trials List
Protocol NumberCAAA817B12301
NCT Number(ClinicalTrials.gov Identfier)NCT06855277
Active
2025-08-01 - 2032-12-31
Phase III
Recruiting5
AcTFirst: A phase III, open-label, multicenter, randomized trial comparing AAA817+ARPI versus standard of care in adult participants with PSMA-positive metastatic castration-resistant prostate cancer
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Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
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Sponsor
Novartis Taiwan Co., Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/07/23
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Co-Principal Investigator
- Yu-Chieh Tsai 無
- Ying-Chun Shen 無
- YU-CHUAN LU 無
- PO-MING CHOW 無
- JIAN-HUA HONG 無
- 曾啟新 無
- 邱士庭 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yeong-Shiau Pu 無
- - - 無
- 闕士傑 無
- CHUNG-HSIN CHEN 無
- JEI-YIE HUANG 無
- JHE-CYUAN GUO 無
- FU-JEN HSUEH 無
- 張晉誠 無
- 王中傑 無
- 吳書丞 無
- 莊佩儒 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Chun-Te Wu
Co-Principal Investigator
- Yung-Chang Lin
- See-Tong Pang Division of Hematology & Oncology
- Rita cheng
- Po-Jung Su
- 黃文冠
- Kai-Jie Yu
- Jing-Ren Tseng
- Kung-Chu Ho
- 沈鼎文
- Hong-Cheng Gan
- I-hung Shao
- PO-HUNG LIN Division of Hematology & Oncology
- 黃意方 Division of Nuclear Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
rPFS was defined as the time elapsed from the date of randomization to the date of the first documented radiographic disease progression or death from any cause as assessed by the Blinded Independent Central Review Committee (BICR) using conventional imaging and Prostate Cancer Working Group 3 (PCWG3) revised RECIST version 1.1 criteria, whichever occurred first.
Objectives
The purpose of this trial was to determine whether [225Ac]Ac-PSMA-617 (AAA817) at a dose of 10 megabequerls (MBq) ± 10% for at least 2 cycles and up to 6 cycles, plus an androgen receptor pathway inhibitor (ARPI), improves blinded independent central evaluation committee (BICR) compared with the trial sponsor's chosen standard of care (SOC) (ARPI switch or taxane-containing chemotherapy). Evaluated radiographic progression-free survival (rPFS), as of last treatment
Adult participants with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) using another ARPI and who had never received taxane-containing chemotherapy in their mCRPC state or any precision radiotherapy targeting PSMA. By including a third group that received AAA817 monotherapy, the contribution of different components (CoC) can be assessed, which helps to assess the relationship between AAA817 and ARPI.
Contribution from the AAA817+ARPI and use group.
Test Drug
AAA617
AAA817
Abiraterone
Cabazitaxel
AAA817
Abiraterone
Cabazitaxel
Active Ingredient
AAA617
[ 225 Ac]Ac-PSMA-617
Abiraterone Acetate
CABAZITAXEL
[ 225 Ac]Ac-PSMA-617
Abiraterone Acetate
CABAZITAXEL
Dosage Form
Injections
Injections
lozenges
infusion solution
Injections
lozenges
infusion solution
Dosage
1000 MBq/mL
1 MBq/mL
250mg
20 mg/ml
1 MBq/mL
250mg
20 mg/ml
Endpoints
rPFS was defined as the time elapsed from the date of randomization to the date of the first documented radiographic disease progression or death from any cause as assessed by the Blinded Independent Central Review Committee (BICR) using conventional imaging and Prostate Cancer Working Group 3 (PCWG3) revised RECIST version 1.1 criteria, whichever occurred first.
Inclution Criteria
• Signed subject consent must be obtained prior to participation in this trial.
• Participants must be adults ≥ 18 years of age.
• Participants must have an East Coast Cancer Collaborative (ECOG) performance status score of 0 to 2.
• Participants must have histologically and/or cytologically confirmed adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) were not eligible.
• Participants must not receive taxane chemotherapy in mCRPC status (allowed in mHSPC status).
• Participants must have PSMA-PET positive disease confirmed using a PSMA contrast agent approved in the trial protocol and determined to be eligible according to the trial sponsor's central interpretation rules.
• Participants must have been diagnosed with mCRPC, received ARPI therapy as last treatment in mHSPC or earlier, and had documented disease progression (and no worsening with more than one ARPI) based on at least 1 of the following criteria: Serum/plasma PSA worsening defined as 2 PSA rises (measured at least 1 week apart). The minimum starting value is 2.0 ng/mL; if an elevated PSA is the only indicator of worsening according to PCWG3 guidelines, the minimum starting value is 1.0 ng/mL.
• Soft tissue deterioration, [as defined by PCWG3 revised RECIST version 1.1 (Eisenhauer et al 2009, Scher et al 2016)].
• Worsening of skeletal disease: 2 new lesions; skeletal metastatic disease can only be defined based on positive bone scan results (PCWG3 condition, Scher et al 2016).
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• Participants must be adults ≥ 18 years of age.
• Participants must have an East Coast Cancer Collaborative (ECOG) performance status score of 0 to 2.
• Participants must have histologically and/or cytologically confirmed adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) were not eligible.
• Participants must not receive taxane chemotherapy in mCRPC status (allowed in mHSPC status).
• Participants must have PSMA-PET positive disease confirmed using a PSMA contrast agent approved in the trial protocol and determined to be eligible according to the trial sponsor's central interpretation rules.
• Participants must have been diagnosed with mCRPC, received ARPI therapy as last treatment in mHSPC or earlier, and had documented disease progression (and no worsening with more than one ARPI) based on at least 1 of the following criteria: Serum/plasma PSA worsening defined as 2 PSA rises (measured at least 1 week apart). The minimum starting value is 2.0 ng/mL; if an elevated PSA is the only indicator of worsening according to PCWG3 guidelines, the minimum starting value is 1.0 ng/mL.
• Soft tissue deterioration, [as defined by PCWG3 revised RECIST version 1.1 (Eisenhauer et al 2009, Scher et al 2016)].
• Worsening of skeletal disease: 2 new lesions; skeletal metastatic disease can only be defined based on positive bone scan results (PCWG3 condition, Scher et al 2016).
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Exclusion Criteria
1. Have previously received any approved or experimental precision radiation targeted therapy (RLT), approved or experimental radioisotope therapy
2. Have received any conventional external radiation therapy, including hemibody radiation therapy, within 6 weeks before randomization (within 2 weeks of radiation therapy for local metastases).
3. Participants with metastatic castration-resistant prostate cancer with known or suspected deleterious germline or somatic homologous recombination repair (HRR) gene mutations.
4. Received any approved or investigational drug/systemic anti-cancer therapy (e.g., other chemotherapy, investigational therapy, immunotherapy, or biologic therapy, including monoclonal antibodies) within 28 days before the expected cycle 1 day 1 (C1D1) (or 5 times the half-life of the therapy, whichever is longer).
5. Diagnosis of other active malignancies expected to alter life expectancy or that may interfere with disease assessment.
6. Patients in the baseline period were based on the National Cancer Institute (NCI) Common Criteria for the Evaluation of Adverse Events (CTCAE) version.
5.0 ≥ grade 2 xerostomia.
2. Have received any conventional external radiation therapy, including hemibody radiation therapy, within 6 weeks before randomization (within 2 weeks of radiation therapy for local metastases).
3. Participants with metastatic castration-resistant prostate cancer with known or suspected deleterious germline or somatic homologous recombination repair (HRR) gene mutations.
4. Received any approved or investigational drug/systemic anti-cancer therapy (e.g., other chemotherapy, investigational therapy, immunotherapy, or biologic therapy, including monoclonal antibodies) within 28 days before the expected cycle 1 day 1 (C1D1) (or 5 times the half-life of the therapy, whichever is longer).
5. Diagnosis of other active malignancies expected to alter life expectancy or that may interfere with disease assessment.
6. Patients in the baseline period were based on the National Cancer Institute (NCI) Common Criteria for the Evaluation of Adverse Events (CTCAE) version.
5.0 ≥ grade 2 xerostomia.
The Estimated Number of Participants
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Taiwan
32 participants
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Global
940 participants
