Prostate CancerNCT03418207
The Accuracy of Modified TTMB in the Spatial Distribution of Prostate Cancer
A study testing trans-perineal template-guided mapping biopsy in people with Prostate Cancer, run by Subei People's Hospital of Jiangsu Province at 1 site in China.
Trial summary
Investigators plan to use modified TTMB technology to puncture prostate of participants suspected prostate cancer, especially those with the first negative biopsy , but having a rising PSA.Then, Investigators will simulate the spatial distribution of prostate cancer in patients with positive biopsy before radical… Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- trans-perineal template-guided mapping biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2018to 31 Dec 2019
- 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 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Male patients;
- 2.18 yrs and older, and 90 yrs and younger;
- 3.Rectal examination reveal prostate nodules;
- 4.B ultrasound, CT or MRI find abnormal images;
- 5.PSA>4ng/ml, abnormal f/t ratio and PSAD
Who cannot join
- Abnormal coagulation function;
- Severe urinary tract infection;
- Serious cardiovascular and cerebrovascular disease
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Subei People's Hospital of Jiangsu province
Yangzhou, Jiangsu, 225001
Xuefei Ding, MD, 18051061234, xuefeid@126.com
About this study
Official title: The Study on the Spatial Distribution of Prostate Cancer by Modified Trans-perineal Template-guided Mapping Biopsy
Investigators plan to use modified TTMB technology to puncture prostate of participants suspected prostate cancer, especially those with the first negative biopsy , but having a rising PSA.Then, Investigators will simulate the spatial distribution of prostate cancer in patients with positive biopsy before radical prostatectomy by way of the TPS software system . And after the radical prostatectomy ,Investigators will simulate the spatial distribution with the help of large tissue slice technique to compare with preoperative simulation ,which to verify the two simulations are consistent.
Read the detailed description
Investigators mainly plan to determine the accuracy of the modified TTMB technology in combination with the TPS system on the location of the tumor space distribution by comparing the two simulation, which is significant for the accurate focal thearpy.
- Conditions
- Prostate Cancer
- Being tested
- trans-perineal template-guided mapping biopsy
- Keywords
- TPS system, trans-perineal template-guided mapping biopsy, prostate cancer, spatial distribution, large tissue slice
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trans-perineal template-guided mapping biopsyProcedure or surgery
new super saturation of prostate biopsy technique
| Study group | Role | What they receive |
|---|---|---|
| TTMB for patients | Other | give trans-perineal template-guided mapping biopsy for participants suspected prostate cancer Receives: Procedure: trans-perineal template-guided mapping biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the spatial distribution based on the biopsy tissue
to simulate the spatial distribution of cancer based on the biopsy tissue contained cancer with the help of TPS system
Measured: 2 years
Secondary outcomes (1)
the spatial distribution based on the large tissue slice technique
to simulate the spatial distribution based on the large tissue slice technique after radical prostatectomy
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start1 Feb 2018
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Subei People's Hospital of Jiangsu Province
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuefei Ding,MD, Subei People's Hospital of Jiangsu Province
- Investigators
- Xuefei Ding, MD, Principal investigator, Subei People's Hospital of Jiangsu Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03418207
- Sponsor's protocol ID
- SubeiPHJP
- Status last verified
- Mar 2018
- First submitted
- 23 Jan 2018
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tran M, Thompson J, Bohm M, Pulbrook M, Moses D, Shnier R, Brenner P, Delprado W, Haynes AM, Savdie R, Stricker PD. Combination of multiparametric MRI and transperineal template-guided mapping biopsy of the prostate to identify candidates for hemi-ablative focal therapy. BJU Int. 2016 Jan;117(1):48-54. doi: 10.1111/bju.13090. Epub 2015 May 11.
PubMed 25682968
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study on the Spatial Distribution of Prostate Cancer by Modified Trans-perineal Template-guided Mapping Biopsy
- ClinicalTrials.gov ID
- NCT03418207
- Acronym / sponsor ID
- SubeiPHJP
- Conditions
- Prostate Cancer
- Keywords
- TPS system, trans-perineal template-guided mapping biopsy, prostate cancer, spatial distribution, large tissue slice
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Subei People's Hospital of Jiangsu ProvinceUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 1 Feb 2018 (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.
Investigators plan to use modified TTMB technology to puncture prostate of participants suspected prostate cancer, especially those with the first negative biopsy , but having a rising PSA.Then, Investigators will simulate the spatial distribution of prostate cancer in patients with positive biopsy before radical prostatectomy by way of the TPS software system . And after the radical prostatectomy ,Investigators will simulate the spatial distribution with the help of large tissue slice technique to compare with preoperative simulation ,which to verify the two simulations are consistent.
Detailed description
Investigators mainly plan to determine the accuracy of the modified TTMB technology in combination with the TPS system on the location of the tumor space distribution by comparing the two simulation, which is significant for the accurate focal thearpy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TTMB for patients | Other | Procedure: trans-perineal template-guided mapping biopsygive trans-perineal template-guided mapping biopsy for participants suspected prostate cancer |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1.Male patients;
- 2.18 yrs and older, and 90 yrs and younger;
- 3.Rectal examination reveal prostate nodules;
- 4.B ultrasound, CT or MRI find abnormal images;
- 5.PSA>4ng/ml, abnormal f/t ratio and PSAD
Key exclusion criteria (3 listed)
- Abnormal coagulation function;
- Severe urinary tract infection;
- Serious cardiovascular and cerebrovascular disease
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 |
|---|---|---|
| trans-perineal template-guided mapping biopsynew super saturation of prostate biopsy technique | Procedure or surgery | TTMB for patients |
Primary outcome
the spatial distribution based on the biopsy tissue
Time frame: 2 years
to simulate the spatial distribution of cancer based on the biopsy tissue contained cancer with the help of TPS system
1 secondary outcome
the spatial distribution based on the large tissue slice technique
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Background: PubMed 25682968Tran M, Thompson J, Bohm M, Pulbrook M, Moses D, Shnier R, Brenner P, Delprado W, Haynes AM, Savdie R, Stricker PD. Combination of multiparametric MRI and transperineal template-guided mapping biopsy of the prostate to identify candidates for hemi-ablative focal therapy. BJU Int. 2016 Jan;117(1):48-54. doi: 10.1111/bju.13090. Epub 2015 May 11.
- Individual participant dataSharing planned: No
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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.
Xuefei Ding, MD principal investigator
Subei People's Hospital of Jiangsu Province
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trans-perineal template-guided mapping biopsy in people with Prostate Cancer, run by Subei People's Hospital of Jiangsu Province 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 5 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 29 Mar 2018. 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 Xuefei Ding, MD (18051061234, xuefeid@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the spatial distribution based on the biopsy tissue (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03418207, which also lists 1 linked publication.
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 29 Mar 2018.