Clinical Trials List
Protocol NumberD972DC00001
NCT Number(ClinicalTrials.gov Identfier)NCT07711002
Not yet recruiting
2026-09-01 - 2033-12-31
Phase III
Not yet recruiting4
A Randomized, Double-Blind, Placebo-Controlled, 2-Cohort, Phase III Study of Saruparib Combined With Physician's Choice of Androgen Receptor Pathway Inhibitor in Patients With Metastatic Hormone-Sensitive Prostate Cancer, Previously Treated With Docetaxel or PSMA-directed 177Lutetium-Containing Therapy Without Disease Progression, and With Prostate-Specific Antigen ≥ 0.2 ng/mL: EvoPAR-Prostate05
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Trial Applicant
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/08/25
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 闕士傑 無
- Yu-Chieh Tsai 無
- Chia-Hsien Chen 無
- JHE-CYUAN GUO 無
- PO-MING CHOW 無
- CHUNG-HSIN CHEN 無
- - - 無
- FU-JEN HSUEH 無
- 吳書丞 無
- CHING-CHU LU 無
- Yeong-Shiau Pu 無
- JIAN-HUA HONG 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 黃文冠 無
- Yung-Chia Kao 無
- 蘇安琪 無
- Kai-Jie Yu 無
- PO-HUNG LIN 無
- 張杰茵 無
- Hong-Cheng Gan 無
- I-hung Shao 無
- See-Tong Pang 無
- Yung-Chang Lin 無
- Feng-Yuan Liu 無
- 李宗霖 無
- Chun-Te Wu 無
- 余紹銘 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Principal Investigator
Yuh-Shyan Tsai
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Objectives
本試驗的目的，是對於在完成 docetaxel 或鎦 PSMA 治療後未發生疾病惡化、且篩選時 PSA ≥ 0.2 ng/mL 的 mHSPC 受試者（無論是否有 HRRm），評估 saruparib 合併 ARPI 相較於安慰劑的療效、安全性和耐受性。
Test Drug
膜衣錠
Active Ingredient
AZD5305
Dosage Form
116
Dosage
20 mg
Endpoints
在 mHSPC 受試者中，透過評估 rPFS，證明 saruparib + 醫師選擇 ARPI 相較於安慰劑 + 醫師選擇 ARPI 之優越性
Inclution Criteria
Inclusion Criteria:
Participant must be ≥ 18 at the time of signing the informed consent.
Histologically documented diagnosis of prostate adenocarcinoma that is de novo or recurrent and hormone-sensitive.
Metastatic disease confirmed prior to initiation of previous treatment with docetaxel or Lu-PSMA-containing regimens for mHSPC.
Previous treatment with docetaxel (IV, Q3w)- or Lu-PSMA (IV, Q6w) with last dose within past 6 months.
Participants must have the following:
Must be receiving ADT with a GnRH analogue or has undergone bilateral orchiectomy.
Had no evidence of disease progression
Had all toxicities related to docetaxel- or Lu-PSMA-containing treatment (except for alopecia and peripheral neuropathy) resolved to CTCAE Grade 1 or lower.
PSA ≥ 0.2 ng/mL within 14 days prior to randomization.
Serum testosterone < 1.7 nmol/L or 50 ng/dL.
Palliative radiotherapy for symptoms management will be permitted and is to be completed at least 4 weeks prior to randomization for wide field radiation therapy and at least 2 weeks prior to randomization for limited field radiation therapy.
Provision of a FFPE tumor tissue sample and a blood sample (for ctDNA).
Confirmed HRRm, HRD and PTEN status.
Adequate organ and bone marrow function.
Minimum life expectancy of 6 months.
Male, assigned at birth, inclusive of all gender identities.
Contraceptive use by participants or participant partners should be consistent with local regulations.
Capable of giving signed informed consent.
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Participant must be ≥ 18 at the time of signing the informed consent.
Histologically documented diagnosis of prostate adenocarcinoma that is de novo or recurrent and hormone-sensitive.
Metastatic disease confirmed prior to initiation of previous treatment with docetaxel or Lu-PSMA-containing regimens for mHSPC.
Previous treatment with docetaxel (IV, Q3w)- or Lu-PSMA (IV, Q6w) with last dose within past 6 months.
Participants must have the following:
Must be receiving ADT with a GnRH analogue or has undergone bilateral orchiectomy.
Had no evidence of disease progression
Had all toxicities related to docetaxel- or Lu-PSMA-containing treatment (except for alopecia and peripheral neuropathy) resolved to CTCAE Grade 1 or lower.
PSA ≥ 0.2 ng/mL within 14 days prior to randomization.
Serum testosterone < 1.7 nmol/L or 50 ng/dL.
Palliative radiotherapy for symptoms management will be permitted and is to be completed at least 4 weeks prior to randomization for wide field radiation therapy and at least 2 weeks prior to randomization for limited field radiation therapy.
Provision of a FFPE tumor tissue sample and a blood sample (for ctDNA).
Confirmed HRRm, HRD and PTEN status.
Adequate organ and bone marrow function.
Minimum life expectancy of 6 months.
Male, assigned at birth, inclusive of all gender identities.
Contraceptive use by participants or participant partners should be consistent with local regulations.
Capable of giving signed informed consent.
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Exclusion Criteria
Exclusion Criteria:
Hypersensitivity to saruparib, ARPI or any excipients of these products or any contraindication or restriction based on the local label.
Any history of persisting (> 2 weeks) severe cytopenia due to any cause (eg, ANC< 0.5 × 10^9/L or platelets < 50 × 10^9/L)
Any known predisposition to bleeding (eg, active peptic ulceration, recent [within6 months] hemorrhagic stroke, proliferative diabetic retinopathy.
Spinal cord compression or brain metastases unless asymptomatic and stable.
History of MDS/AML or with features suggestive of MDS/AML
History of another primary malignancy, with some exceptions.
Any chronic gastrointestinal diseases or conditions including inability to swallow the formulated product that would preclude adequate absorption of any study drug.
History of seizure or predispose to seizure, including any history of loss of consciousness or transient ischemic attack within 12 months of enrolment.
Serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.
Major surgical procedure or significant traumatic injury within 4 weeks of the first dose or an anticipated need for major surgery during the study.
Switched ARPI agent in previous treatment for mHSPC due to disease progression. Note: if the ARPI agent was switched due to any reason other than disease progression and switch was prior to ICF signature, participants will be eligible.
Any prior treatment with a PARPi or platinum chemotherapy.
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Hypersensitivity to saruparib, ARPI or any excipients of these products or any contraindication or restriction based on the local label.
Any history of persisting (> 2 weeks) severe cytopenia due to any cause (eg, ANC< 0.5 × 10^9/L or platelets < 50 × 10^9/L)
Any known predisposition to bleeding (eg, active peptic ulceration, recent [within6 months] hemorrhagic stroke, proliferative diabetic retinopathy.
Spinal cord compression or brain metastases unless asymptomatic and stable.
History of MDS/AML or with features suggestive of MDS/AML
History of another primary malignancy, with some exceptions.
Any chronic gastrointestinal diseases or conditions including inability to swallow the formulated product that would preclude adequate absorption of any study drug.
History of seizure or predispose to seizure, including any history of loss of consciousness or transient ischemic attack within 12 months of enrolment.
Serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.
Major surgical procedure or significant traumatic injury within 4 weeks of the first dose or an anticipated need for major surgery during the study.
Switched ARPI agent in previous treatment for mHSPC due to disease progression. Note: if the ARPI agent was switched due to any reason other than disease progression and switch was prior to ICF signature, participants will be eligible.
Any prior treatment with a PARPi or platinum chemotherapy.
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The Estimated Number of Participants
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Taiwan
50 participants
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Global
1330 participants
