Prostate CanceriPROLOGXNCT02460861
Intraoperational Prostate Loge Biopsies (iPROLOGX) After Radical Prostatovesiculectomy
A study testing biopsies of the prostatic fossa in Magdeburg, RPVE and ETRARP in people with Prostate Cancer, run by University of Magdeburg at 2 sites in Germany.
Trial summary
This project is about the detection of occult tumor cells in surgical margins of radical prostatovesiculectomy by analysing the methylation status of Glutathione S-transferase P 1 (GSTP1). After gland excision specimens are obtained from 9 defined areas of the prostatic fossa. The biopsies are divided into two parts. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- biopsies of the prostatic fossa in Magdeburg, RPVE and ETRARP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 279 participants
- Where
- 2 sitesGermany
- Study dates
- Nov 2011to Dec 2015
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- sex: male
- diagnosis: prostate adenocarcinoma
- treatment: radical prostatovesiculectomy
- period of treatment: 11/30/2011 - 10/15/2013
- sex: male
- diagnosis: urothelial carcinoma
- treatment: cysto-prostatectomy
- period of treament: 12/14/2011 - 02/18/2014
Who cannot join
- sex: female
- diagnosis: no prostate adenocarcinoma
- treatment: no radical prostatovesiculectomy
- period of treament: before 11/30/2011 or after 10/15/2013
- Criteria for prostate adenocarcinoma negative control group:
- sex: female
Show all 9Show fewer
- diagnosis: incidental prostate adenocarcinoma
- treatment: no cysto-prostatectomy
- period of treatment: before 12/14/2011 or after 02/18/2014
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
St. Antonius Hospital
Gronau, North Rhine-Westphalia, 48599
Department of Urology, University Clinic Otto von Guericke University Magdeburg
Magdeburg, Saxony-Anhalt, 39120
About this study
Official title: Intraoperational Prostate Loge Biopsies (iPROLOGX) After Radical Prostatovesiculectomy (RPVE) in Prostate Cancer (PCA) Patients for Molecular Tumor Marker Analysis
This project is about the detection of occult tumor cells in surgical margins of radical prostatovesiculectomy by analysing the methylation status of Glutathione S-transferase P 1 (GSTP1). After gland excision specimens are obtained from 9 defined areas of the prostatic fossa. The biopsies are divided into two parts. One part used for histopathological analysis and the other part for moleculargenetic analysis. Results will be correlated e.g. with tumor stage, Gleason Score and prostate specific antigen (PSA).
The prostate-cancer-negative control group with bladder cancer.
Read the detailed description
This project is about the detection of occult tumor cells in surgical margins of radical prostatovesiculectomy by analysing the methylation status of Glutathione S-transferase P 1 (GSTP1). After gland excision specimens are obtained from 9 defined areas of the prostatic fossa. The biopsies are divided into two parts. One part used for histopathological analysis and the other part for moleculargenetic analysis. Results will be correlated e.g. with tumor stage, Gleason Score and prostate specific antigen (PSA).
The prostate-cancer-negative control group with bladder cancer.
DNA ISOLATION
DNA from biopsies stored by -80°C was isolated by using innuPREP DNA mini Kit (Analytik Jena, Jena, Germany) following protocol 1 of the manufacturer's instructions. DNA was eluted with 50 µl elution buffer. Concentration and purity were analysed by using Nanodrop 2000.
DNA BISULFITE MODIFICATION
DNA was modified by using EpiTect Bisulfite Kit (QIAGEN, Hilden, Germany) according to manufacturer's instructions. Samples were eluted once with 20 µl elution buffer.
QUANTITATIVE METHYLATION SPECIFIC PCR
Methylation status of GSTP1 is analysed by quantitative methylation-specific PCR (Q-MSP) using StepOnePlus Real-Time PCR System and StepOne Software v2.1 from Applied Biosystems (Darmstadt, Germany). Q-MSP was performed in duplicate analysing genes Actin and GSTP1. The primers' and testing probes' sequences used to amplify and detect hypermethylated GSTP1 were: 5'-AgTTgCgCggCgATTTC (forward primer), 5'-gCCCCAATACTAAATCACgACg (reverse primer) and 5'-CggTCgACgTTCggggTgTAgCg (taqman probe), labelled with fluorescence dye FAM. The primers' and testing probes' sequences used to amplify and detect Actin were: 5'-TggTgATggAggAggTTTAgTAAgT (forward primer), 5'-AACCAATAAAACCTACTCCTCCCTTAA (reverse primer),5'-ACCACCACCCAACACACAATAACAAACACA (taqman probe), labelled with fluorescence dye VIC.
The Q-MSP was carried out at 50°C for 2 min., 95°C for 15 min. followed by 50 cycles of 95°C for 1s and 60°C for 1 min. As a positive control bisulfite-converted DNA of DU145 and LNCap were used. Blank reactions with destillated water, which replaced DNA, served as negative control (NTC).
- Conditions
- Prostate Cancer
- Being tested
- biopsies of the prostatic fossa in Magdeburg, RPVE, ETRARP, CE, biopsies of the prostatic fossa in gronau
- Keywords
- Prostate Cancer, Molecular staging, GSTP1, Surgical margins, prostatovesiculectomy
- Medical subject headings
- Prostatic Neoplasms, Margins of Excision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsies of the prostatic fossa in MagdeburgProcedure or surgery
Also called surgical biopsies
intraoperative Open surgical biopsies of the prostatic fossa after prostatevesiculectomy in Magdeburg
RPVEProcedure or surgery
Also called surgical prostatectomy
Open Radical prostatovesiculectomy in Magdeburg
ETRARPProcedure or surgery
Also called surgical prostatectomy
Robotassisted Radical prostatovesiculectomy in Gronau
CEProcedure or surgery
Also called surgical cystoprostatectomy
Open cystectomy in Magdeburg/Gronau
biopsies of the prostatic fossa in gronauProcedure or surgery
Also called surgical biopsies
intraoperative endoscopic robotassisted biopsies of the prostatic fossa after prostatevesiculectomy in Gronau
| Study group | Role | What they receive |
|---|---|---|
| PCA Magdeburg | Active comparator | Prostate cancer conducted for RPVE with curative Intention, biopsies of the prostatic fossa in Magdeburg Receives: Procedure: biopsies of the prostatic fossa in Magdeburg; Procedure: RPVE |
| Non-prostate cancer Magdeburg/Gronau | Active comparator | Conducted for CE in Male with bladder cancer or other indication for cystectomy but without prostate cancer in Magdeburg or Gronau, biopsies of the prostatic fossa in Gronau Receives: Procedure: biopsies of the prostatic fossa in Magdeburg; Procedure: CE; Procedure: biopsies of the prostatic fossa in gronau |
| PCA Gronau | Active comparator | Prostate cancer conducted for ETRARP with curative Intention, biopsies of the prostatic fossa Receives: Procedure: ETRARP; Procedure: biopsies of the prostatic fossa in gronau |
What is being measured
The primary outcome is the main question the study is designed to answer.
Methylation status of GSTP1
Methylation status of GSTP1 is analysed by quantitative methylation-specific PCR (Q-MSP)
Measured: 2 years
Histopathology of prostate fossa biopsies
Histopathology of prostate fossa biopsies (Prostata cancer positive or negative)
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 posted3 Jun 2015 (estimated)
- Study startNov 2011
- Primary completionOct 2013
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Magdeburg
- Sponsor type
- University, hospital or other
- Collaborators
- St. Antonius Hospital Gronau
- Responsible party
- Principal investigator, Johann J. Wendler, MD, University of Magdeburg
- Investigators
- Martin Schostak, Prof.Dr.med., Study chair, University of Magdeburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02460861
- Sponsor's protocol ID
- MD-URO-00021
- Acronym
- iPROLOGX
- Status last verified
- May 2015
- First submitted
- 28 May 2015
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperational Prostate Loge Biopsies (iPROLOGX) After Radical Prostatovesiculectomy (RPVE) in Prostate Cancer (PCA) Patients for Molecular Tumor Marker Analysis
- ClinicalTrials.gov ID
- NCT02460861
- Acronym / sponsor ID
- iPROLOGX / MD-URO-00021
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Molecular staging, GSTP1, Surgical margins, prostatovesiculectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 279 participants (actual)
- Lead sponsor
- University of MagdeburgUniversity, hospital or other
- Collaborators
- St. Antonius Hospital Gronau
- Study start
- Nov 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 3 Jun 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 project is about the detection of occult tumor cells in surgical margins of radical prostatovesiculectomy by analysing the methylation status of Glutathione S-transferase P 1 (GSTP1). After gland excision specimens are obtained from 9 defined areas of the prostatic fossa. The biopsies are divided into two parts. One part used for histopathological analysis and the other part for moleculargenetic analysis. Results will be correlated e.g. with tumor stage, Gleason Score and prostate specific antigen (PSA).
The prostate-cancer-negative control group with bladder cancer.
Detailed description
This project is about the detection of occult tumor cells in surgical margins of radical prostatovesiculectomy by analysing the methylation status of Glutathione S-transferase P 1 (GSTP1). After gland excision specimens are obtained from 9 defined areas of the prostatic fossa. The biopsies are divided into two parts. One part used for histopathological analysis and the other part for moleculargenetic analysis. Results will be correlated e.g. with tumor stage, Gleason Score and prostate specific antigen (PSA).
The prostate-cancer-negative control group with bladder cancer.
DNA ISOLATION
DNA from biopsies stored by -80°C was isolated by using innuPREP DNA mini Kit (Analytik Jena, Jena, Germany) following protocol 1 of the manufacturer's instructions. DNA was eluted with 50 µl elution buffer. Concentration and purity were analysed by using Nanodrop 2000.
DNA BISULFITE MODIFICATION
DNA was modified by using EpiTect Bisulfite Kit (QIAGEN, Hilden, Germany) according to manufacturer's instructions. Samples were eluted once with 20 µl elution buffer.
QUANTITATIVE METHYLATION SPECIFIC PCR
Methylation status of GSTP1 is analysed by quantitative methylation-specific PCR (Q-MSP) using StepOnePlus Real-Time PCR System and StepOne Software v2.1 from Applied Biosystems (Darmstadt, Germany). Q-MSP was performed in duplicate analysing genes Actin and GSTP1. The primers' and testing probes' sequences used to amplify and detect hypermethylated GSTP1 were: 5'-AgTTgCgCggCgATTTC (forward primer), 5'-gCCCCAATACTAAATCACgACg (reverse primer) and 5'-CggTCgACgTTCggggTgTAgCg (taqman probe), labelled with fluorescence dye FAM. The primers' and testing probes' sequences used to amplify and detect Actin were: 5'-TggTgATggAggAggTTTAgTAAgT (forward primer), 5'-AACCAATAAAACCTACTCCTCCCTTAA (reverse primer),5'-ACCACCACCCAACACACAATAACAAACACA (taqman probe), labelled with fluorescence dye VIC.
The Q-MSP was carried out at 50°C for 2 min., 95°C for 15 min. followed by 50 cycles of 95°C for 1s and 60°C for 1 min. As a positive control bisulfite-converted DNA of DU145 and LNCap were used. Blank reactions with destillated water, which replaced DNA, served as negative control (NTC).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PCA Magdeburg | Active comparator | Procedure: biopsies of the prostatic fossa in Magdeburg, Procedure: RPVEProstate cancer conducted for RPVE with curative Intention, biopsies of the prostatic fossa in Magdeburg |
| Non-prostate cancer Magdeburg/Gronau | Active comparator | Procedure: biopsies of the prostatic fossa in Magdeburg, Procedure: CE, Procedure: biopsies of the prostatic fossa in gronauConducted for CE in Male with bladder cancer or other indication for cystectomy but without prostate cancer in Magdeburg or Gronau, biopsies of the prostatic fossa in Gronau |
| PCA Gronau | Active comparator | Procedure: ETRARP, Procedure: biopsies of the prostatic fossa in gronauProstate cancer conducted for ETRARP with curative Intention, biopsies of the prostatic fossa |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- sex: male
- diagnosis: prostate adenocarcinoma
- treatment: radical prostatovesiculectomy
- period of treatment: 11/30/2011 - 10/15/2013
- sex: male
Key exclusion criteria (9 listed)
- sex: female
- diagnosis: no prostate adenocarcinoma
- treatment: no radical prostatovesiculectomy
- period of treament: before 11/30/2011 or after 10/15/2013
- sex: female
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 |
|---|---|---|
| biopsies of the prostatic fossa in MagdeburgAlso: surgical biopsiesintraoperative Open surgical biopsies of the prostatic fossa after prostatevesiculectomy in Magdeburg | Procedure or surgery | Non-prostate cancer Magdeburg/Gronau, PCA Magdeburg |
| RPVEAlso: surgical prostatectomyOpen Radical prostatovesiculectomy in Magdeburg | Procedure or surgery | PCA Magdeburg |
| ETRARPAlso: surgical prostatectomyRobotassisted Radical prostatovesiculectomy in Gronau | Procedure or surgery | PCA Gronau |
| CEAlso: surgical cystoprostatectomyOpen cystectomy in Magdeburg/Gronau | Procedure or surgery | Non-prostate cancer Magdeburg/Gronau |
| biopsies of the prostatic fossa in gronauAlso: surgical biopsiesintraoperative endoscopic robotassisted biopsies of the prostatic fossa after prostatevesiculectomy in Gronau | Procedure or surgery | Non-prostate cancer Magdeburg/Gronau, PCA Gronau |
Primary outcome
Methylation status of GSTP1
Time frame: 2 years
Methylation status of GSTP1 is analysed by quantitative methylation-specific PCR (Q-MSP)
Histopathology of prostate fossa biopsies
Time frame: 2 years
Histopathology of prostate fossa biopsies (Prostata cancer positive or negative)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
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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.
Martin Schostak, Prof.Dr.med. study chair
University of Magdeburg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biopsies of the prostatic fossa in Magdeburg, RPVE and ETRARP in people with Prostate Cancer, run by University of Magdeburg at 2 sites in Germany.
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 8 inclusion and 9 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 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
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?
Methylation status of GSTP1 (time frame: 2 years). 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 3 Jun 2015.