Hormone Refractory Prostate CancerNCT01590498
Radiotherapy vs Observation for CRPC
An observational study of Hormone Refractory Prostate Cancer, run by Zhengzhou University at 1 site in China.
Trial summary
The purpose of the study is to determine whether radiotherapy improves cancer control and overall survival among patients with Castration resistant prostate cancer. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Hormone Refractory Prostate Cancer
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- May 2012to Mar 2017
- Phase
- Observational
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: inpatients with CRPC in 9 hospitals
Who may be able to join
- Eligible patients had histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiologic evidence of disease progression during hormonal therapy
- Patients were receiving primary androgen-ablation therapy as maintenance therapy. At least four weeks had to have elapsed between the withdrawal of antiandrogens (six weeks in the case of bicalutamide) and enroll ment, so as to avoid the possibility of confounding as a result of the response to antiandrogen withdrawal.
- Another requirement was disease progression, as indicated by increasing serum levels of PSA on three consecutive measurements obtained at least one week apart or findings on physical examination or imaging studies.
- Normal cardiac function was required.
Who cannot join
- patients had a Karnofsky performance-status score of at most 60 percent
- prior treatment with cytotoxic agents or radioisotopes
- with history of another cancer within the preceding five years, brain or leptomeningeal metastases, symptomatic peripheral neuropathy of grade 2 or higher, and other serious medical condition.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the first affiliated hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
Official title: Salvage Radiotherapy vs Observation for Castration Resistant Prostate Cancer in Central China
The purpose of the study is to determine whether radiotherapy improves cancer control and overall survival among patients with Castration resistant prostate cancer.
- Conditions
- Hormone Refractory Prostate Cancer
- Keywords
- Adenocarcinoma, Prostatic Neoplasms, Carcinoma, Prostatic Diseases
- Medical subject headings
- Adenocarcinoma, Prostatic Neoplasms, Carcinoma, Prostatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Salvage radiotherapy | local radiation to the prostate and metastasis following biochemical or clinical recurrence | |
| observation | did not receive salvage following biochemical or clinical recurrence |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: From the date of biochemical or clinical recurrence of prostate cancer following hormonal therapy to December 31, 2016 or date of death from any cause, whichever came first, assessed up to 3 years.
Secondary outcomes (1)
prostate cancer specific mortality
Measured: From the date of biochemical or clinical recurrence of prostate cancer following hormonal therapy to December 31, 2016 or death from prostate cancer or treatment complications, whichever came first, assessed up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone Refractory Prostate CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhengzhou University
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, Henan Cancer Hospital, People's Hospital of Zhengzhou University, Xinyang Central Hospital, Zhoukou Central Hospital, the second people's hospital of kaifeng
- Responsible party
- Principal investigator, Liu Bingqian, Zhengzhou University
- Investigators
- Liu Bingqian, MD Ph.D, Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590498
- Sponsor's protocol ID
- PCA0608
- Other IDs
- NNSFC
- Status last verified
- May 2012
- First submitted
- 27 Apr 2012
- Last updated
- 4 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salvage Radiotherapy vs Observation for Castration Resistant Prostate Cancer in Central China
- ClinicalTrials.gov ID
- NCT01590498
- Acronym / sponsor ID
- PCA0608
- Conditions
- Hormone Refractory Prostate Cancer
- Keywords
- Adenocarcinoma, Prostatic Neoplasms, Carcinoma, Prostatic Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Zhengzhou UniversityUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, Henan Cancer Hospital, People's Hospital of Zhengzhou University, Xinyang Central Hospital, Zhoukou Central Hospital, the second people's hospital of kaifeng
- Study start
- May 2012
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 3 May 2012 (estimated)
- 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.
The purpose of the study is to determine whether radiotherapy improves cancer control and overall survival among patients with Castration resistant prostate cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salvage radiotherapy | – | –local radiation to the prostate and metastasis following biochemical or clinical recurrence |
| observation | – | –did not receive salvage following biochemical or clinical recurrence |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- inpatients with CRPC in 9 hospitals
Key inclusion criteria (4 listed)
- Eligible patients had histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiologic evidence of disease progression during hormonal therapy
- Patients were receiving primary androgen-ablation therapy as maintenance therapy. At least four weeks had to have elapsed between the withdrawal of antiandrogens (six weeks in the case of bicalutamide) and enroll ment, so as to avoid the possibility of confounding as a result of the response to antiandrogen withdrawal.
- Another requirement was disease progression, as indicated by increasing serum levels of PSA on three consecutive measurements obtained at least one week apart or findings on physical examination or imaging studies.
- Normal cardiac function was required.
Key exclusion criteria (3 listed)
- patients had a Karnofsky performance-status score of at most 60 percent
- prior treatment with cytotoxic agents or radioisotopes
- with history of another cancer within the preceding five years, brain or leptomeningeal metastases, symptomatic peripheral neuropathy of grade 2 or higher, and other serious medical condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
overall survival
Time frame: From the date of biochemical or clinical recurrence of prostate cancer following hormonal therapy to December 31, 2016 or date of death from any cause, whichever came first, assessed up to 3 years.
1 secondary outcome
prostate cancer specific mortality
Time frame: From the date of biochemical or clinical recurrence of prostate cancer following hormonal therapy to December 31, 2016 or death from prostate cancer or treatment complications, whichever came first, assessed up to 3 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2012.
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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.
Liu Bingqian, MD Ph.D principal investigator
The First Affiliated Hospital of Zhengzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hormone Refractory Prostate Cancer, run by Zhengzhou University at 1 site 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 4 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liu Bingqian, MD Ph.D (86-371-66862101, liubq76@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: From the date of biochemical or clinical recurrence of prostate cancer following hormonal therapy to December 31, 2016 or date of death from any cause, whichever came first, assessed up to 3 years.). 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 4 May 2012.