Evaluation of the efficacy of Olapani combined with Cisplatin in metastatic castration resistant prostate cancer with DNA repair gene defects

An open, randomized, controlled, prospective phase II clinical trial of Olapani combined with Cisplatin for disease progression free survival in patients with metastatic castration resistant prostate cancer with DNA repair gene defects

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000036694

Enrollment

Unknown

Registered

2020-08-24

Start date

2020-10-01

Completion date

Unknown

Last updated

2020-09-21

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

Conditions

Prostate cancer

Interventions

Combined treatment:Olaprib combined with cisplatin

Monotherapy:Olaprib

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Male; 2. The age is more than or equal to 18 years old and less than or equal to 80 years old; 3. Patients with prostate adenocarcinoma confirmed by histopathology or cytopathology; 4. Imaging examination revealed the presence of metastatic lesions; 5. Castration resistance has been found after using endocrine therapy; 6. ctDNA examination found that there were harmful DNA damage repair gene mutations according to the reported 7. Good health, ECOG score 0 or 1; 8. The patients participated voluntarily and signed the informed consent form; 9. Patients must be able to receive treatments and follow-ups.

Exclusion criteria

Exclusion criteria: 1. Patients have received radiotherapy and chemotherapy for the primary lesion and metastases; 2. Small cell carcinoma of prostate; 3. Patients who could not tolerate the complications of Olapani; 4. Patients with poor general condition or contraindications to chemotherapy; 5. The patients are not willing to accept the related complications caused by the combined treatment; 7. History of other malignant tumors (except skin basal cell carcinoma or other tumors which have been cured for more than 5 years); 8. Other serious underlying diseases, such as: unstable heart disease after treatment, myocardial infarction within 6 months before treatment, cardiac function grade 3-4 (NYHA); hypertension beyond the control of medical treatment (more than 150 / 90mmHg, serious neurological or psychological disorders including dementia or epilepsy; uncontrolled active infection; acute gastric ulcer; hypercalcemia; and those requiring hospitalization Chronic obstructive pulmonary disease; 9. Participated in other clinical studies before enrollment.

Design outcomes

Primary

Measure	Time frame
Radiologic progression;Time to PSA progression;	—

Secondary

Measure	Time frame
Overall survival;PSA response rate;Equality life;	—

Countries

China

Contacts

Public ContactKun Chang

Fudan University Shanghai Cancer Center

changkungene@126.com+86 15121124650

Outcome results

None listed

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