DNA-repair defects and Platinum-based chemotherapy in metastatic castration-resistant prostate cancer

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-OPC-16009563

Enrollment

Unknown

Registered

2016-10-23

Start date

2016-10-31

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prostate cancer

Interventions

single arm:Oxaliplatin plus pemetrexed

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Male aged 18 Years and older; 2. with histological diagnosis of adenocarcinoma of the prostate; 3. Metastatic Castration-Resistant Prostate Cancer (mCRPC); 4. Progression after at least one therapy with a newer hormonal agent (Cyp17 inhibitor or a new generation AA like enzalutamide) or who cannot have one of the newer hormonal agent; 5. Progression of disease by any of the criteria listed here: PSA utilizing PCWG 2 criteria Bone scan RECIST 1.1 6. with DNA repair defects; 7. No prior chemotherapy (except estramustine); 8. Eastern Cooperative Oncology Group (ECOG) performance Status (PS) 0 - 2; 9. Haemoglobin =9.0 g/dL; 10. Platelet count =100x10^9/L; 11. Absolute neutrophil count =1.5x10^9/L; 12. Total bilirubin < 1.5 x ULN,AST and/or ALT < 2.5 x ULN; 13. Creatinine Clearance =45ml/min; 14. Written Informed Consent.

Exclusion criteria

Exclusion criteria: 1. Prior treatment with chemotherapy(except estramustine); 2. Known symptomatic uncontrolled brain or leptomeningeal metastases; 3. Myocardial infarction, percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass graft, New York Heart Association (NYHA) class III/IV congestive heart failure, cerebrovascular accident, transient ischaemic attack, or limb claudication at rest, within 6 months prior to start of study treatment; 4. Any condition, including other active or latent infections, medical or psychiatric conditions, or the presence of laboratory abnormalities, which could confound the ability to interpret data from the study or places the patient at unacceptable risk if he participates in the study; 5. Without get written Informed Consent. 6)Prior treatment with a poly (adenosine diphosphate [ADP] ribose) polymerase (PARP) inhibitor 7)Contraindications to the class of drugs under study 8)Other malignant tumors have suffered in the past three years 9)Any patient who in the opinion of the Investigator should not participate in the study

Design outcomes

Primary

Measure	Time frame
Response Rate;	—

Secondary

Measure	Time frame
Rate of PSA declines of =30%;Overall survival;Radiological progression-free survival (rPFS);Time to PSA progression;Safety;	—

Countries

China

Contacts

Public ContactZhongquan Sun

Huadong hospital, Fudan University

drzhongquan@sina.cn+86 13301807126

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026