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Completed

NCT Number: NCT04056754

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

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.

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Key information

Conditions

Metastatic Castration Resistant Prostate Cancer

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Peking Union Medical College Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1.18 years and older, Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, Life expectancy ≥ 6 months.
  • 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.
  • Has not used opioid analgesics and azole drugs within 4 weeks before the first dose.
  • Question 3 of the Concise Pain Questionnaire (BPI-SF) scored from 0-3 points.
  • 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

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

Treatment and study plan

Abiraterone Acetate

Drug

Subjects administered 4 tablets abiraterone acetate twice daily in 28-day cycle.

Placebo

Drug

Subjects administered 4 tablets abiraterone acetate blank analog tablet twice daily in 28-day cycle.

Prednisone

Drug

Subjects administered 5mg prednisone twice daily in 28-day cycle.

Primary outcomes

  1. Time to PSA progression (TTPP）

    Time frame: Baseline up to 24 months

    The time interval between the administration of the drug and the progression of serum prostate specific antigen (PSA).

Secondary outcomes

  1. Prostate specific antigen remission time

    Time frame: Baseline up to 24 months

    It was ≥50% lower than the baseline, and was confirmed as remission after re-testing after ≥4 weeks.

  2. Objective Response Rate (ORR)

    Time frame: Baseline up to 24 months

    The percentage of participants with a best overall response defined as complete response (CR) or partial response (PR).

  3. Eastern Cooperative Oncology Group (ECOG)

    Time frame: Baseline up to 24 months

    The ECOG scoring standard is an indicator of the general health status and tolerance to treatment from the patient's physical strength. ECOG physical status score standard from 0 to 5. Starting with the dose until the score increases from the baseline.

  4. Overall Survival (OS)

    Time frame: Baseline up to 24 months

    Time from date of randomization to date of death due to any cause.

  5. To pain progression time

    Time frame: Baseline up to 24 months

    Time from the start of medication to the progression of pain.

  6. Quality of life assessment scale (FACT-P)

    Time frame: Baseline up to 24 months

    Functional Assessment of Cancer Therapy- Prostate Cancer (FACT-P) total score, Functional Assessment of Cancer Therapy- General (FACT-G) total score, trial outcome index, functional well-being, physical well-being, prostate cancer subscale, and Functional Assessment of Cancer Therapy (FACT) Advanced Prostate Symptom Index-6 (FAPSI-6).

  7. Prostate specific antigen remission rate

    Time frame: Baseline up to 24 months

    The remission rate was defined as the proportion of remissions to the total number of people.

Sponsors and collaborators

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Industry

Registry information

Official study title

A Randomised, Double-Blind, Multicentre Phase Ⅲ Study to Evaluate Abiraterone Acetate Versus Placebo Combined With Prednisone in Subjects With Asymptomatic or Mild Symptoms Without Chemotherapy, Metastatic Castration Resistant Prostate Cancer.

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Aug 14, 2019
Registry last updated
Aug 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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