Study of Abiraterone Acetate in Subjects With Metastatic Castration Resistant Prostate Cancer

CTTQ

Status and phase: Completed; Phase 3

Conditions: Metastatic Castration Resistant Prostate Cancer

Treatments: Drug: Prednisone; Drug: Placebo; Drug: Abiraterone Acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT04056754

CTTQL-ABTL

Details and patient eligibility

About

Abiraterone acetate is an orally effective CYP17 inhibitor, which is metabolized into abiraterone in the body, and its inhibitory activity against CYP17 is 10-30 times that of ketoconazole. Clinical studies have shown that abiraterone acetate can significantly reduce the level of prostate specific antigen (PSA) in PCa patients, and help to reduce tumors, extending the lifespan of patients with advanced PCa for several years, and the toxicity is acceptable.

Enrollment: 268 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1.18 years and older, Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, Life expectancy ≥ 6 months.

2. Prostate cancer. 3. Serum testosterone <50 ng/dL (or 1.7 nmol/L). 4. Prostate cancer progression or lesion metastasis. 5. Restriction of antiandrogen therapy. 6. Restriction of Radiation therapy. 7. The treatment period of ketoconazole for prostate cancer was not exceed 7 days.

3. Has not used opioid analgesics and azole drugs within 4 weeks before the first dose.

4. Question 3 of the Concise Pain Questionnaire (BPI-SF) scored from 0-3 points.

5. Adequate laboratory indicators. 11. Must be able to swallow tablets. 12. No pregnant or breastfeeding women, and a negative pregnancy test. 13. Understood and signed an informed consent form.

Exclusion criteria

1. Prostate pathology results are neuroendocrine prostate cancer.
2. Has received cytotoxic chemotherapy or biological therapy for metastatic castration resistant prostate cancer.
3. Has contraindications to the use of prednisone.
4. A chronic disease that exceeds the prednisone dose in the study.
5. Uncontrolled high blood pressure.
6. Active or symptomatic viral hepatitis or other chronic liver disease.
7. Visceral metastasis or brain metastasis.
8. Pituitary or adrenal dysfunction.
9. Active autoimmune diseases require the use of hormone therapy.
10. Clinically significant heart disease.
11. Participated in other clinical trials within 4 weeks.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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268 participants in 2 patient groups, including a placebo group

Abiraterone acetate group

Experimental group

Description:

Subjects in this group administered 4 tablets abiraterone acetate once daily and 5mg prednisone twice daily, in 28-day cycle on fasting conditions.

Treatment:

Drug: Abiraterone Acetate

Drug: Prednisone

Placebo group

Placebo Comparator group

Description:

Subjects in this group administered 4 tablets abiraterone acetate blank analog tablet once daily and 5mg prednisone twice daily, in 28-day cycle on fasting conditions.

Treatment:

Drug: Placebo

Drug: Prednisone