Stage IV Prostate CancerCRYO-PCA-IVNCT02615223
Endocrine Therapy With or Without Cryoablation for Stage IV Prostate Cancer
A study testing cryoablation, Bicalutamide and luteinizing-hormone releasing-hormone (LHRH) agonist in people with Stage IV Prostate Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This trial is going to evaluate tumor control and quality of life in patients with prostate cancer treated with endocrine therapy with or without cryoablation. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Stage IV Prostate Cancer
- What is being tested?
- cryoablation, Bicalutamide and luteinizing-hormone releasing-hormone (LHRH) agonist
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to Dec 2018
- Phase
- Interventional
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prostate adenocarcinoma, T4N0M0, Any T with N+ or M+
- Previously untreated disease or undergone endocrine therapy without reaching to castration resistant prostate cancer
- Survival ≥ 12 months
- WHO performance status 0-2
- white blood cell ≥ 3.5 ×10*9/L
- Platelets ≥ 5×10*9/L
- Hemoglobin ≥ 10 g/dL
Who cannot join
- History of malignant disease
- History of coronary artery disease
- Uncontrolled infection
- Other concurrent severe or uncontrolled medical disease that could compromise participation in the study (i.e., uncontrolled diabetes mellitus, uncontrolled cardiac disease, uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within the past six months, chronic liver or renal disease, and active upper gastrointestinal tract ulceration)
- Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study treatment and follow-up schedule
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Zhi Guo, PhD, 02223340123 ext. 1095, cjr.guozhi@vip.163.com
Tongguo Si, PhD, 02223340123 ext. 1095, sitg77@163.com
About this study
Official title: A Prospective Multi-center Study to Compare the QOL and Efficacy of Endocrine Therapy With or Without Cryoablation for Stage IV Prostate Cancer.
This trial is going to evaluate tumor control and quality of life in patients with prostate cancer treated with endocrine therapy with or without cryoablation.
Read the detailed description
OBJECTIVES:
- To determine the tumor control in patients with prostate cancer treated with radiotherapy or cryoablation
- To determine the quality of life of these patients. OUTLINE: This is a multicenter study. Patients are stratified according to Gleason score (≥ 8 vs 7 vs ≤ 6), persistent prostatic specific antigen (PSA) at allocation (> 0.5 ng/mL vs ≤ 0.5 ng/mL), participating center. Patient are allocated to two treatment arms.
- Conditions
- Stage IV Prostate Cancer
- Being tested
- cryoablation, Bicalutamide, luteinizing-hormone releasing-hormone (LHRH) agonist
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryoablationProcedure or surgery
Cryoablation therapy
BicalutamideDrug
bicalutamide
luteinizing-hormone releasing-hormone (LHRH) agonistDrug
luteinizing-hormone releasing-hormone (LHRH) agonist
| Study group | Role | What they receive |
|---|---|---|
| Arm1 | Experimental | Patients receive oral bicalutamide once daily on days 1-28. Patients also receive luteinizing-hormone releasing-hormone (LHRH) agonist treatment intramuscularly (IM) on day 8. Treatment with LHRH agonist repeats every 12 weeks for 24 weeks.
Patients receive cryoablation therapy. Receives: Procedure: cryoablation; Drug: Bicalutamide; Drug: luteinizing-hormone releasing-hormone (LHRH) agonist |
| Arm2 | Experimental | Patients receive oral bicalutamide once daily on days 1-28. Patients also receive luteinizing-hormone releasing-hormone (LHRH) agonist treatment intramuscularly (IM) on day 8. Treatment with LHRH agonist repeats every 12 weeks for 24 weeks. Receives: Drug: Bicalutamide; Drug: luteinizing-hormone releasing-hormone (LHRH) agonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median biochemical progression-free survival
It measures the time to biochemical progression (PSA progression).
Measured: Within 12 months after treatment
Quality of Life impact of treatments' side effects measured by change in EORTC QOL-C30 from baseline to 3, 6 and 12 months after treatment
European Organization for Research and Treatment of Cancer(EORTC)
Measured: 3, 6 and 12 months after treatment
Secondary outcomes (2)
Overall survival
Measured: 5 year
Disease Specific Survival
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IV Prostate CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University First Hospital, Tianjin First Central Hospital, Shandong Cancer Hospital and Institute, Shanghai Jiao Tong University School of Medicine, The Third Xiangya Hospital of Central South University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Responsible party
- Sponsor
- Investigators
- Zhi Guo, Principal investigator, Tianjin Medical University Cancer Institue and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02615223
- Sponsor's protocol ID
- TMU-CIH-IR-005
- Acronym
- CRYO-PCA-IV
- Status last verified
- Nov 2015
- First submitted
- 17 Nov 2015
- Last updated
- 12 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-center Study to Compare the QOL and Efficacy of Endocrine Therapy With or Without Cryoablation for Stage IV Prostate Cancer.
- ClinicalTrials.gov ID
- NCT02615223
- Acronym / sponsor ID
- CRYO-PCA-IV / TMU-CIH-IR-005
- Conditions
- Stage IV Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Collaborators
- Peking University First Hospital, Tianjin First Central Hospital, Shandong Cancer Hospital and Institute, Shanghai Jiao Tong University School of Medicine, The Third Xiangya Hospital of Central South University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Study start
- Nov 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 26 Nov 2015 (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.
This trial is going to evaluate tumor control and quality of life in patients with prostate cancer treated with endocrine therapy with or without cryoablation.
Detailed description
OBJECTIVES:
- To determine the tumor control in patients with prostate cancer treated with radiotherapy or cryoablation
- To determine the quality of life of these patients. OUTLINE: This is a multicenter study. Patients are stratified according to Gleason score (≥ 8 vs 7 vs ≤ 6), persistent prostatic specific antigen (PSA) at allocation (> 0.5 ng/mL vs ≤ 0.5 ng/mL), participating center. Patient are allocated to two treatment arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm1 | Experimental | Procedure: cryoablation, Drug: Bicalutamide, Drug: luteinizing-hormone releasing-hormone (LHRH) agonistPatients receive oral bicalutamide once daily on days 1-28. Patients also receive luteinizing-hormone releasing-hormone (LHRH) agonist treatment intramuscularly (IM) on day 8. Treatment with LHRH agonist repeats every 12 weeks for 24 weeks. Patients receive cryoablation therapy. |
| Arm2 | Experimental | Drug: Bicalutamide, Drug: luteinizing-hormone releasing-hormone (LHRH) agonistPatients receive oral bicalutamide once daily on days 1-28. Patients also receive luteinizing-hormone releasing-hormone (LHRH) agonist treatment intramuscularly (IM) on day 8. Treatment with LHRH agonist repeats every 12 weeks for 24 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Prostate adenocarcinoma, T4N0M0, Any T with N+ or M+
- Previously untreated disease or undergone endocrine therapy without reaching to castration resistant prostate cancer
- Survival ≥ 12 months
- WHO performance status 0-2
- white blood cell ≥ 3.5 ×10*9/L
Key exclusion criteria (5 listed)
- History of malignant disease
- History of coronary artery disease
- Uncontrolled infection
- Other concurrent severe or uncontrolled medical disease that could compromise participation in the study (i.e., uncontrolled diabetes mellitus, uncontrolled cardiac disease, uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within the past six months, chronic liver or renal disease, and active upper gastrointestinal tract ulceration)
- Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study treatment and follow-up schedule
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 |
|---|---|---|
| cryoablationCryoablation therapy | Procedure or surgery | Arm1 |
| Bicalutamidebicalutamide | Drug | Arm1, Arm2 |
| luteinizing-hormone releasing-hormone (LHRH) agonistluteinizing-hormone releasing-hormone (LHRH) agonist | Drug | Arm1, Arm2 |
Primary outcome
Median biochemical progression-free survival
Time frame: Within 12 months after treatment
It measures the time to biochemical progression (PSA progression).
Quality of Life impact of treatments' side effects measured by change in EORTC QOL-C30 from baseline to 3, 6 and 12 months after treatment
Time frame: 3, 6 and 12 months after treatment
European Organization for Research and Treatment of Cancer(EORTC)
2 secondary outcomes
Overall survival
Time frame: 5 year
Disease Specific Survival
Time frame: 5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2017.
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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.
Zhi Guo principal investigator
Tianjin Medical University Cancer Institue and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cryoablation, Bicalutamide and luteinizing-hormone releasing-hormone (LHRH) agonist in people with Stage IV Prostate Cancer, run by Tianjin Medical University Cancer Institute and Hospital 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 7 inclusion and 5 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 12 Jun 2017. 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 Zhi Guo, PhD (02223340123 ext. 1095, cjr.guozhi@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median biochemical progression-free survival (time frame: Within 12 months after treatment). The study lists 2 primary outcomes in all. 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 12 Jun 2017.