Clinical Trials List
Protocol NumberCAAA817B12301
NCT Number(ClinicalTrials.gov Identfier)NCT06855277
Active
2025-08-01 - 2032-12-31
Phase III
Recruiting2
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 Pharmaceuticals
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
吳俊德
Co-Principal Investigator
- 黃意方
- Yung-Chang Lin
- Kung-Chu Ho
- Po-Jung Su Division of Hematology & Oncology
- I-hung Shao
- Rita cheng
- 黃文冠 Division of Hematology & Oncology
- PO-HUNG LIN
- Hong-Cheng Gan
- Jing-Ren Tseng Division of Nuclear Medicine
- See-Tong Pang
- 沈鼎文
- Kai-Jie Yu
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
PSMA-positive Metastatic Castration Resistant Prostate Cancer
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) 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
[ 225 Ac]Ac-PSMA-617
Active Ingredient
[ 225 Ac]Ac-PSMA-617
Dosage Form
solution for injection
Dosage
1 MBq/mL
Endpoints
PSMA-positive Metastatic Castration Resistant Prostate Cancer.Time to radiographic disease progression or death due to any cause.
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 or ARPI change 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).
-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 or ARPI change 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).
Exclusion Criteria
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.
-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.
The Estimated Number of Participants
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Taiwan
18 participants
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Global
605 participants
