Metastatic Castration Resistant Prostate CancerPhase 3NCT04056754
Study of Abiraterone Acetate in Subjects With Metastatic Castration Resistant Prostate Cancer
A Phase 3 study testing Abiraterone Acetate and Prednisone in people with Metastatic Castration Resistant Prostate Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 16 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration Resistant Prostate Cancer
- What is being tested?
- Abiraterone Acetate and Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 268 participants
- Where
- 16 sitesChina
- Study dates
- 16 Jul 2014to 16 Jul 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 8. Has not used opioid analgesics and azole drugs within 4 weeks before the first dose.
- 9. Question 3 of the Concise Pain Questionnaire (BPI-SF) scored from 0-3 points.
- 10. 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100000
Peking University First Hospital
Beijing, Beijing Municipality, 100000
West China Hospital，Sichuan University
Chengdu, Sichuan, 610000
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400000
Sun-Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510000
The Second Affiliated Hospital of Zhenjiang University School of Medicine
Hangzhou, Zhejiang, 310000
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000
Qilu Hospital of Shandong University
Jinan, Shandong, 250000
Jiangsu Province Hospital
Nanjing, Jiangsu, 210000
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530000
Fudan University Medical College Affiliated Huadong Hospital
Shanghai, Shanghai Municipality, 200000
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000
RenJi Hospital of Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200000
Guangzhou Military Region Wuhan General Hospital
Wuhan, Hubei, 430000
TongJi medical college of HuaZhong University of Science & Technology Affiliated TongJi Hospital
Wuhan, Hubei, 430000
Henan Cancer Hospital
Zhengzhou, Henan, 450000
About this study
Official 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.
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.
- Being tested
- Abiraterone Acetate, Placebo, Prednisone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abiraterone AcetateDrug
Subjects administered 4 tablets abiraterone acetate twice daily in 28-day cycle.
PlaceboDrug
Subjects administered 4 tablets abiraterone acetate blank analog tablet twice daily in 28-day cycle.
PrednisoneDrug
Subjects administered 5mg prednisone twice daily in 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Abiraterone acetate group | Experimental | Subjects in this group administered 4 tablets abiraterone acetate once daily and 5mg prednisone twice daily, in 28-day cycle on fasting conditions. Receives: Drug: Abiraterone Acetate; Drug: Prednisone |
| Placebo group | Placebo comparator | 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. Receives: Drug: Placebo; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to PSA progression (TTPP）
The time interval between the administration of the drug and the progression of serum prostate specific antigen (PSA).
Measured: Baseline up to 24 months
Secondary outcomes (7)
Prostate specific antigen remission time
It was ≥50% lower than the baseline, and was confirmed as remission after re-testing after ≥4 weeks.
Measured: Baseline up to 24 months
Objective Response Rate (ORR)
The percentage of participants with a best overall response defined as complete response (CR) or partial response (PR).
Measured: Baseline up to 24 months
Eastern Cooperative Oncology Group (ECOG)
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.
Measured: Baseline up to 24 months
Overall Survival (OS)
Time from date of randomization to date of death due to any cause.
Measured: Baseline up to 24 months
To pain progression time
Time from the start of medication to the progression of pain.
Measured: Baseline up to 24 months
Quality of life assessment scale (FACT-P)
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).
Measured: Baseline up to 24 months
Prostate specific antigen remission rate
The remission rate was defined as the proportion of remissions to the total number of people.
Measured: Baseline up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start16 Jul 2014
- Primary completion14 Mar 2018
- Study completion16 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration Resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056754
- Sponsor's protocol ID
- CTTQL-ABTL
- Status last verified
- Apr 2016
- First submitted
- 11 Aug 2019
- Last updated
- 14 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT04056754
- Acronym / sponsor ID
- CTTQL-ABTL
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Jul 2014 (actual)
- Primary completion
- 14 Mar 2018 (actual)
- Study completion
- 16 Jul 2019 (actual)
- First posted
- 14 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abiraterone acetate group | Experimental | Drug: Abiraterone Acetate, Drug: PrednisoneSubjects in this group administered 4 tablets abiraterone acetate once daily and 5mg prednisone twice daily, in 28-day cycle on fasting conditions. |
| Placebo group | Placebo comparator | Drug: Placebo, Drug: PrednisoneSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- 8. Has not used opioid analgesics and azole drugs within 4 weeks before the first dose.
- 9. Question 3 of the Concise Pain Questionnaire (BPI-SF) scored from 0-3 points.
- 10. 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abiraterone AcetateSubjects administered 4 tablets abiraterone acetate twice daily in 28-day cycle. | Drug | Abiraterone acetate group |
| PlaceboSubjects administered 4 tablets abiraterone acetate blank analog tablet twice daily in 28-day cycle. | Drug | Placebo group |
| PrednisoneSubjects administered 5mg prednisone twice daily in 28-day cycle. | Drug | Abiraterone acetate group, Placebo group |
Primary outcome
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).
7 secondary outcomes
Prostate specific antigen remission time
Time frame: Baseline up to 24 months
Objective Response Rate (ORR)
Time frame: Baseline up to 24 months
Eastern Cooperative Oncology Group (ECOG)
Time frame: Baseline up to 24 months
Overall Survival (OS)
Time frame: Baseline up to 24 months
To pain progression time
Time frame: Baseline up to 24 months
Quality of life assessment scale (FACT-P)
Time frame: Baseline up to 24 months
Prostate specific antigen remission rate
Time frame: Baseline up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Abiraterone Acetate and Prednisone in people with Metastatic Castration Resistant Prostate Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 16 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to PSA progression (TTPP） (time frame: Baseline up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.