Urinary Bladder NeoplasmsSTERPROSERNCT02778243
Sexual Steroids: Relationship Between Serum and Prostatic Tissue Level
A study testing steroids concentrations determination in people with Urinary Bladder Neoplasms and Prostate Hyperplasia, run by Hopital Foch at 1 site in France.
Trial summary
Patients followed in the Foch Hospital Urology Department (Suresnes): Patients justifying a prostatectomy. Patients justifying prostatectomy together with the bladder (radical cystectomy for bladder cancer). Patients with benign prostate hyperplasia who justified a prostatectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urinary Bladder Neoplasms, Prostate Hyperplasia
- What is being tested?
- steroids concentrations determination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2014to 12 Nov 2016
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men aged over 18 years
- Surgical indication justifying protatique prostatectomy, or complete prostatocystectomie, or removal of a metastasis of prostate cancer.
- Patients affiliated to a social security scheme or benefiting from such a regime.
- Patients who have given their consent to participate in writing
Who cannot join
- Patient received local therapy or hormonal treatment (LHRH analogue, therapy blocking androgen receptors) before surgery.
- Treatment reductase inhibitors 5ARI ongoing or stopped for less than 3 months before the intervention.
- Patient included in another clinical trial inconsistent with the conduct of this research.
- Patient receiving treatment that could interfere with hormone levels (Prednisone, Ketoconazole, Abiraterone, Finasteride, Dutasteride).
Trial locations and contacts
1 site in 1 country.
About this study
Patients followed in the Foch Hospital Urology Department (Suresnes): Patients justifying a prostatectomy.
- Patients justifying prostatectomy together with the bladder (radical cystectomy for bladder cancer).
- Patients with benign prostate hyperplasia who justified a prostatectomy. Compare serum sexual steroid concentrations and intra-tissue on healthy prostates and prostate adenoma, assess concentrations intra-tissue sex steroids on cancer metastasis prostate specific blood sample under study (30mL) will be performed preoperatively in Patients followed in Foch Hospital Urology Department (Suresnes), and a Removal of a fragment of prostate tissue or metastasis will be analyze.
Aim is to compare serum concentrations of sexual steroids and intra-tissue on healthy prostates and prostate adenomas compared to concentrations measured in patients operated for prostate cancer.
Read the detailed description
Steroids concentration will be determined using Gas chromatography-mass spectrometry. The analyzed steroids are :
FSH :Mul/ml LH: mUI/ml SHBG: µg/ml BT: ng/ml TT: ng/ml DHT: ng/ml DHEA: ng/ml D5: ng/ml D4: ng/ml E1: pg/ml E2 : pg/ml DHEA-S : µg/dl
- Conditions
- Urinary Bladder Neoplasms, Prostate Hyperplasia
- Being tested
- steroids concentrations determination
- Medical subject headings
- Urinary Bladder Neoplasms, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
steroids concentrations determinationBiological
| Study group | Role | What they receive |
|---|---|---|
| Bladder cancer | Experimental | ▪ Patients justifying prostatectomy together with the bladder (radical cystectomy for bladder cancer). Receives: Biological: steroids concentrations determination |
| benign prostate hyperplasia | Other | ▪ Patients with benign prostate hyperplasia who justified a prostatectomy. Receives: Biological: steroids concentrations determination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum concentrations of sexual steroids and intra-tissue on healthy prostates
A bio-informatical analysis will be performed to compare steroids concentrations profiles in both arms.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startSep 2014
- Primary completion12 Nov 2016
- Study completion12 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder NeoplasmsStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henry Botto, PhD, Principal investigator, Urologie Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778243
- Sponsor's protocol ID
- 2014/01
- Other IDs
- 2014-A00706-41
- Acronym
- STERPROSER
- Status last verified
- Nov 2016
- First submitted
- 12 May 2016
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Steroids: Relationship Between Serum and Prostatic Tissue Level
- ClinicalTrials.gov ID
- NCT02778243
- Acronym / sponsor ID
- STERPROSER / 2014/01
- Conditions
- Urinary Bladder Neoplasms, Prostate Hyperplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- 12 Nov 2016 (actual)
- Study completion
- 12 Nov 2016 (actual)
- First posted
- 19 May 2016 (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.
Patients followed in the Foch Hospital Urology Department (Suresnes): Patients justifying a prostatectomy.
- Patients justifying prostatectomy together with the bladder (radical cystectomy for bladder cancer).
- Patients with benign prostate hyperplasia who justified a prostatectomy. Compare serum sexual steroid concentrations and intra-tissue on healthy prostates and prostate adenoma, assess concentrations intra-tissue sex steroids on cancer metastasis prostate specific blood sample under study (30mL) will be performed preoperatively in Patients followed in Foch Hospital Urology Department (Suresnes), and a Removal of a fragment of prostate tissue or metastasis will be analyze.
Aim is to compare serum concentrations of sexual steroids and intra-tissue on healthy prostates and prostate adenomas compared to concentrations measured in patients operated for prostate cancer.
Detailed description
Steroids concentration will be determined using Gas chromatography-mass spectrometry. The analyzed steroids are :
FSH :Mul/ml LH: mUI/ml SHBG: µg/ml BT: ng/ml TT: ng/ml DHT: ng/ml DHEA: ng/ml D5: ng/ml D4: ng/ml E1: pg/ml E2 : pg/ml DHEA-S : µg/dl
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bladder cancer | Experimental | Biological: steroids concentrations determination▪ Patients justifying prostatectomy together with the bladder (radical cystectomy for bladder cancer). |
| benign prostate hyperplasia | Other | Biological: steroids concentrations determination▪ Patients with benign prostate hyperplasia who justified a prostatectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men aged over 18 years
- Surgical indication justifying protatique prostatectomy, or complete prostatocystectomie, or removal of a metastasis of prostate cancer.
- Patients affiliated to a social security scheme or benefiting from such a regime.
- Patients who have given their consent to participate in writing
Key exclusion criteria (4 listed)
- Patient received local therapy or hormonal treatment (LHRH analogue, therapy blocking androgen receptors) before surgery.
- Treatment reductase inhibitors 5ARI ongoing or stopped for less than 3 months before the intervention.
- Patient included in another clinical trial inconsistent with the conduct of this research.
- Patient receiving treatment that could interfere with hormone levels (Prednisone, Ketoconazole, Abiraterone, Finasteride, Dutasteride).
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 |
|---|---|---|
| steroids concentrations determination | Biological | Bladder cancer, benign prostate hyperplasia |
Primary outcome
Serum concentrations of sexual steroids and intra-tissue on healthy prostates
Time frame: 30 minutes
A bio-informatical analysis will be performed to compare steroids concentrations profiles in both arms.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- 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.
Henry Botto, PhD principal investigator
Urologie Hopital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing steroids concentrations determination in people with Urinary Bladder Neoplasms and Prostate Hyperplasia, run by Hopital Foch at 1 site in France.
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 4 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: finished, as of the sponsor's last update on 14 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Serum concentrations of sexual steroids and intra-tissue on healthy prostates (time frame: 30 minutes). 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 14 Jun 2017.