Prostate CancerHORMNCT03014973
Castration-resistant Prostate Cancer and Intra-prostatic Hormonal Status
A study testing intra-prostatic concentration of sexual steroids and Trans-rectal biopsy in people with Prostate Cancer, run by Hopital Foch at 1 site in France.
Trial summary
The main objective of the study is to determine the intra-prostatic concentration of sexual steroids when castration resistance appears in castration-resistant prostate cancer patients compared to patients naif of hormonal treatment Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- intra-prostatic concentration of sexual steroids and Trans-rectal biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2017to 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- group 1: patients with a locally advanced prostate cancer naif of any hormonal treatment
- group 2: Patients with a castration-resistant prostate cancer resisting defined by a biological progression
- group 2a: without radiotherapy
- group 2b: with radiotherapy
- Affiliated to a social security scheme
- Having given a written consent.
Who cannot join
- Patient unable to supply a written consent (patient not understanding French, under guardianship patient).
- neuro-endocrine form or sarcomatoid form prostate cancer
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of the study is to determine the intra-prostatic concentration of sexual steroids when castration resistance appears in castration-resistant prostate cancer patients compared to patients naif of hormonal treatment
- Conditions
- Prostate Cancer
- Being tested
- intra-prostatic concentration of sexual steroids, Trans-rectal biopsy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-prostatic concentration of sexual steroidsBiological
Trans-rectal biopsyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| prostate cancer patients resistant to castration | Experimental | Not described Receives: Biological: intra-prostatic concentration of sexual steroids; Procedure: Trans-rectal biopsy |
| patients naif of hormonal treatment | Experimental | Not described Receives: Biological: intra-prostatic concentration of sexual steroids; Procedure: Trans-rectal biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
intra-prostatic concentration of sexual steroids
Measured: 2 weeks
Secondary outcomes (6)
Androgen receptor immuno-histochemical expression level
Measured: 2 weeks
Androgen receptor RNA expression level
Measured: 2 weeks
Steroid 5-alphareductase immuno-histochemical expression level
Measured: 2 weeks
Steroid 5-alphareductase RNA expression level
Measured: 2 weeks
Steroid aromatase immuno-histochemical expression level
Measured: 2 weeks
Steroid aromatase RNA expression level
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study startJan 2017 (estimated)
- Primary completionJun 2018 (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 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yann NEUZILLET, MD, Principal investigator, Hopital FochHenry Botto, MD, Study chair, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014973
- Sponsor's protocol ID
- 2016/03
- Other IDs
- 2016-A00020-51
- Acronym
- HORM
- Status last verified
- Jan 2017
- First submitted
- 30 Dec 2016
- Last updated
- 13 Sep 2018
- 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 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Castration-resistant Prostate Cancer and Intra-prostatic Hormonal Status
- ClinicalTrials.gov ID
- NCT03014973
- Acronym / sponsor ID
- HORM / 2016/03
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Jan 2017 (estimated)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 9 Jan 2017 (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.
The main objective of the study is to determine the intra-prostatic concentration of sexual steroids when castration resistance appears in castration-resistant prostate cancer patients compared to patients naif of hormonal treatment
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prostate cancer patients resistant to castration | Experimental | Biological: intra-prostatic concentration of sexual steroids, Procedure: Trans-rectal biopsy |
| patients naif of hormonal treatment | Experimental | Biological: intra-prostatic concentration of sexual steroids, Procedure: Trans-rectal biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- group 1: patients with a locally advanced prostate cancer naif of any hormonal treatment
- group 2: Patients with a castration-resistant prostate cancer resisting defined by a biological progression
- group 2a: without radiotherapy
- group 2b: with radiotherapy
- Affiliated to a social security scheme
Key exclusion criteria (2 listed)
- Patient unable to supply a written consent (patient not understanding French, under guardianship patient).
- neuro-endocrine form or sarcomatoid form prostate cancer
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 |
|---|---|---|
| intra-prostatic concentration of sexual steroids | Biological | patients naif of hormonal treatment, prostate cancer patients resistant to castration |
| Trans-rectal biopsy | Procedure or surgery | patients naif of hormonal treatment, prostate cancer patients resistant to castration |
Primary outcome
intra-prostatic concentration of sexual steroids
Time frame: 2 weeks
6 secondary outcomes
Androgen receptor immuno-histochemical expression level
Time frame: 2 weeks
Androgen receptor RNA expression level
Time frame: 2 weeks
Steroid 5-alphareductase immuno-histochemical expression level
Time frame: 2 weeks
Steroid 5-alphareductase RNA expression level
Time frame: 2 weeks
Steroid aromatase immuno-histochemical expression level
Time frame: 2 weeks
Steroid aromatase RNA expression level
Time frame: 2 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
- Individual participant dataSharing planned: No
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RecruitingPhase 1
A Study of JNJ-98768111 in Participants With Advanced Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 3
A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer
Prostatic Neoplasms, Castration-Resistant
RecruitingPhase 2
Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells
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RecruitingPhase 3
Testing Different Dosing Schedules of the Anti-cancer Drug, Lutetium 177Lu PSMA RLT and Its Effect on Patients With Advanced Prostate Cancer, RECIPROCAL Trial
Metastatic Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma
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.
Yann NEUZILLET, MD principal investigator
Hopital Foch
Henry Botto, MD study chair
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 intra-prostatic concentration of sexual steroids and Trans-rectal biopsy in people with Prostate Cancer, 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 6 inclusion and 2 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: withdrawn, as of the sponsor's last update on 13 Sep 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 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 was withdrawn before enrolling participants, so there are no results.
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?
intra-prostatic concentration of sexual steroids (time frame: 2 weeks). 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 13 Sep 2018.