Prostate Cancer MetastaticNCT03988686
Testing Radical Prostatectomy in Chinese Men With Prostate Cancer and oligoMetastases to the Bone
A study of Prostate Cancer Metastatic, run by Fudan University at 1 site in China.
Trial summary
This study is to examine whether radical prostatectomy can impact survival and quality-of-life in men with oligo-metastatic prostate cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Prostate Cancer Metastatic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 31 Mar 2022
- 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 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants is willing and able to give informed consent for participation in the study
- Male aged 19-75 years.
- Diagnosed with oligo-metastatic prostate cancer (1-3 skeletal lesions on bone specific imaging, no visceral metastases).
- Locally resectable tumor (clinical/radiological stage T1-T3).
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Suitable for radical prostatectomy within 12 months of starting standard care.
Who cannot join
- Contraindications to radical prostatectomy.
- Visceral metastases.
- Prior radiotherapy to the abdomen/pelvis or to skeletal metastases.
- Any systemic therapy of prostate cancer (including standard care) for 12 or more months prior to enrollment.
- Current involvement in other interventional research.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Jian-Ming Guo, MD, PhD, +86 13681971306, guo.jianming@zs-hospital.sh.cn
Lei Xu, MD, PhD, +86 18616139981, xu.lei1@zs-hospital.sh.cn
About this study
Official title: Zhongshan Hospital, Fudan University
This study is to examine whether radical prostatectomy can impact survival and quality-of-life in men with oligo-metastatic prostate cancer.
Read the detailed description
In this study, patients with oligo-metastatic prostate cancer will be randomized to radical prostatectomy plus standard care and standard care only. Standard care refers to androgen deprivation therapy (ADT) +/- other systemic therapies. Time to disease progression and post-treatment quality of life will be assessed and compared.
- Conditions
- Prostate Cancer Metastatic
- Being tested
- Radical prostatectomy plus standard care, Standard of care for metastatic prostate cancer
- Keywords
- oligometastasis, prostate cancer, radical prostatectomy, progression-free survival, quality of life
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical prostatectomy plus standard careProcedure or surgery
To add radical prostatectomy on the basis of current standard of care for those with oligometastatic prostate cancer
Standard of care for metastatic prostate cancerDrug
androgen deprivation therapy with or without other systemic therapies based on current guidelines for metastatic prostate cancer
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Radical prostatectomy plus standard care Receives: Procedure: Radical prostatectomy plus standard care; Drug: Standard of care for metastatic prostate cancer |
| Comparator Group | Active comparator | Standard care, currently ADT +/- other systemic therapies. Receives: Drug: Standard of care for metastatic prostate cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
the time to castrate resistance
The time to treatment failure defined as castrate resistance will be recorded via routine patient follow-up interviews.
Measured: 36 months after randomization
Secondary outcomes (1)
Quality of life in patients post-randomization
EuroQOL 5 dimensions 5 levels (EQ-5D-5L) questionnaire will be used to assess quality of life in patients after randomization with different treatments. This is designed to measure health-related quality of life. It consists of a questionnaire and a visual analogue scale. The subjects in 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression are asked to grade their own current level of function in each dimension into one of five levels of disability (i.e. I have no problems waling about, slight problems, moderate problems, severe problems, or unable to walk). This tool also has an overall health scale where the rater selects a number between 1-100 to describe the condition of their health, 100 being the best imaginable.
Measured: three month post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start1 Apr 2019
- Primary completion31 Mar 2021 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London
- Responsible party
- Principal investigator, Jianming Guo, Fudan University
- Investigators
- Jian-Ming Guo, MD, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03988686
- Sponsor's protocol ID
- B2019-065
- Status last verified
- Jun 2019
- First submitted
- 8 Jun 2019
- Last updated
- 17 Jun 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 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zhongshan Hospital, Fudan University
- ClinicalTrials.gov ID
- NCT03988686
- Acronym / sponsor ID
- B2019-065
- Conditions
- Prostate Cancer Metastatic
- Keywords
- oligometastasis, prostate cancer, radical prostatectomy, progression-free survival, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- University College, London
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 17 Jun 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.
This study is to examine whether radical prostatectomy can impact survival and quality-of-life in men with oligo-metastatic prostate cancer.
Detailed description
In this study, patients with oligo-metastatic prostate cancer will be randomized to radical prostatectomy plus standard care and standard care only. Standard care refers to androgen deprivation therapy (ADT) +/- other systemic therapies. Time to disease progression and post-treatment quality of life will be assessed and compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Procedure: Radical prostatectomy plus standard care, Drug: Standard of care for metastatic prostate cancerRadical prostatectomy plus standard care |
| Comparator Group | Active comparator | Drug: Standard of care for metastatic prostate cancerStandard care, currently ADT +/- other systemic therapies. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants is willing and able to give informed consent for participation in the study
- Male aged 19-75 years.
- Diagnosed with oligo-metastatic prostate cancer (1-3 skeletal lesions on bone specific imaging, no visceral metastases).
- Locally resectable tumor (clinical/radiological stage T1-T3).
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Key exclusion criteria (5 listed)
- Contraindications to radical prostatectomy.
- Visceral metastases.
- Prior radiotherapy to the abdomen/pelvis or to skeletal metastases.
- Any systemic therapy of prostate cancer (including standard care) for 12 or more months prior to enrollment.
- Current involvement in other interventional research.
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 |
|---|---|---|
| Radical prostatectomy plus standard careTo add radical prostatectomy on the basis of current standard of care for those with oligometastatic prostate cancer | Procedure or surgery | Intervention Group |
| Standard of care for metastatic prostate cancerandrogen deprivation therapy with or without other systemic therapies based on current guidelines for metastatic prostate cancer | Drug | Comparator Group, Intervention Group |
Primary outcome
the time to castrate resistance
Time frame: 36 months after randomization
The time to treatment failure defined as castrate resistance will be recorded via routine patient follow-up interviews.
1 secondary outcome
Quality of life in patients post-randomization
Time frame: three month post randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 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.
Jian-Ming Guo, MD, PhD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Prostate Cancer Metastatic, run by Fudan 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 6 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 17 Jun 2019. 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 Jian-Ming Guo, MD, PhD (+86 13681971306, guo.jianming@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the time to castrate resistance (time frame: 36 months after randomization). 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 17 Jun 2019.