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, multi-center, randomized study 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
2026/09/14
Investigators and Locations
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
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
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
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 or [177Lu]Lu-PSMA-617 (AAA617)) 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.
Objectives
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 or [177Lu]Lu-PSMA-617 (AAA617)) 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.
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
Injection
Injection
Tablet
Solution for infusion
Injection
Tablet
Solution for infusion
Dosage
1000 MBq/mL
1 MBq/mL
250mg
20 mg/ml
1 MBq/mL
250mg
20 mg/ml
Endpoints
Radiographic Progression Free Survival (rPFS) Time to radiographic disease progression or death due to any cause. From the date of randomization to the date of the first documented radiographic disease progression using conventional imaging, or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.
Inclution 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.
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
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.
Note: Prior ARPI administered in the mHSPC setting or earlier may continue until C1D1.
Other protocol-defined inclusion/exclusion criteria may apply.
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.
Note: Prior ARPI administered in the mHSPC setting or earlier may continue until C1D1.
Other protocol-defined inclusion/exclusion criteria may apply.
The Estimated Number of Participants
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Taiwan
32 participants
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Global
940 participants
