Prostate CancerNCT02366494
Micro RNAs to Predict Response to Androgen Deprivation Therapy
An observational study of Prostate Cancer, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
Identify exosomal micro RNA that predict responses to ADT Read more about this study
- Who is it for?
- Ages 21 to 85 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Bicalutamide, Leuprolide and Goserelin
- Type of treatment
- Pill or oral medicine
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2015to 11 May 2021
- Phase
- Observational
- 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 21 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men with systemic disease ( with biochemical relpase or metastaic disease)
Who may be able to join
- Histologically proven prostate cancer.
- Testosterone level >30ng/ml and at least 6 months since last dose of hormonal therapy.
- History/physical examination including a detailed description of the stage of prostate cancer within 8 weeks prior to registration.
- CT scan of abdomen and pelvis with IV contrast and bone scan should be performed within 8 weeks prior to registration.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
- Age ≥ 18.
- Patients must provide study-specific informed consent prior to study entry for this project and mandatory blood specimen for banking for future studies (future studies may include genetic testing).
Who cannot join
- Received hormonal therapy less than 6 months prior to registration.
- History of active secondary malignancy.
- Decline hormone therapy for prostate cancer.
- Current or previous treatment with 5-alpha reductase inhibitors within 6 months prior to enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Utility of Exosomal microRNAs to Predict Response to Androgen Deprivation Therapy in Prostate Cancer Patients
Identify exosomal micro RNA that predict responses to ADT
Read the detailed description
- Identify novel exosomal RNA signatures at pretreatment that predict response to ADT. The study team will collect blood samples from patients with systemic disease pretreatment (at enrollment), three months post-treatment and at the time of progression of disease (or at two years post-ADT for patients still in remission at that time point) and then perform next-generation sequencing using serum exosomal RNAs derived from these patients. The investigators plan to identify exosomal RNAs signatures that change between pretreatment (at enrollment) and during treatment (at three months) and further explore the effect of these changes on disease response. The investigators also plan to compare exosomal RNA levels between patients relapse within the first two years versus those in remission at two years. Among patients with progression, the investigators plan to compare exosomal RNA signatures at progression of disease to signatures at pretreatment and during treatment.
- Validate exosomal RNA markers that predict response to ADT by real-time RT-PCR.
Secondary objectives: Selected RNAs, identified through the above process will be validated using real-time RT-PCR assay to test reproducibility of RNA sequencing results. The investigators expect to select and validate approximate five RNA markers that predict duration of response to ADT.
- Conditions
- Prostate Cancer
- Being tested
- Bicalutamide, Leuprolide, Goserelin, Triptorelin, Docetaxel
- Keywords
- prostate cancer, treatment response, androgen deprivation therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BicalutamideDrug
Also called Casodex
ANDROGEN BLOCKADE
LeuprolideDrug
Also called Lupron
ANDROGEN BLOCKADE
GoserelinDrug
Also called Zoladex
ANDROGEN BLOCKADE
TriptorelinDrug
Also called Trelstar
ANDROGEN BLOCKADE
DocetaxelDrug
Also called Taxotere
Chemo hormonal therapy
AbirateroneDrug
Also called Zytiga
Chemo hormonal therapy
ApalutamideDrug
Also called Erleada
Nonsteroidal antiandrogen medication
EnzalutamideDrug
Also called Xtandi
Nonsteroidal antiandrogen medication
| Study group | Role | What they receive |
|---|---|---|
| Androgen blockade | Androgen DeprivationTherapy or Complete Androgen Blockade Receives: Drug: Bicalutamide; Drug: Leuprolide; Drug: Goserelin; Drug: Triptorelin | |
| Hormonal Therapy and Chemotherapy | Hormonal therapy, novel oral hormonal therapy (abiraterone/apalutamide/enzalutamide) and chemotherapy (docetaxel) Receives: Drug: Bicalutamide; Drug: Leuprolide; Drug: Goserelin; Drug: Triptorelin; Drug: Docetaxel; Drug: Abiraterone; Drug: Apalutamide; Drug: Enzalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify five most prevalent exosomal microRNAs that predict response to androgen deprivation therapy based treatment.
Two hundred to 300 microRNAs will be identified by RNA sequencing. This outcome measure will report the read count per million of the top-five most prevalent microRNAs that correlate with responses.
Measured: Up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study start29 Apr 2015
- Primary completion11 May 2021
- Study completion11 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deepak Kilari, Medical College of Wisconsin
- Investigators
- Deepak Kilari, MD, Principal investigator, The Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02366494
- Sponsor's protocol ID
- 23842
- Status last verified
- Nov 2024
- First submitted
- 12 Feb 2015
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Taplin ME, Xie W, Bubley GJ, Ernstoff MS, Walsh W, Morganstern DE, Regan MM. Docetaxel, estramustine, and 15-month androgen deprivation for men with prostate-specific antigen progression after definitive local therapy for prostate cancer. J Clin Oncol. 2006 Dec 1;24(34):5408-13. doi: 10.1200/JCO.2006.06.6589.
PubMed 17135641Scher HI, Halabi S, Tannock I, Morris M, Sternberg CN, Carducci MA, Eisenberger MA, Higano C, Bubley GJ, Dreicer R, Petrylak D, Kantoff P, Basch E, Kelly WK, Figg WD, Small EJ, Beer TM, Wilding G, Martin A, Hussain M; Prostate Cancer Clinical Trials Working Group. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol. 2008 Mar 1;26(7):1148-59. doi: 10.1200/JCO.2007.12.4487.
PubMed 18309951Huggins C, Hodges CV. Studies on prostatic cancer. I. The effect of castration, of estrogen and androgen injection on serum phosphatases in metastatic carcinoma of the prostate. CA Cancer J Clin. 1972 Jul-Aug;22(4):232-40. doi: 10.3322/canjclin.22.4.232. No abstract available.
PubMed 4625049
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Exosomal microRNAs to Predict Response to Androgen Deprivation Therapy in Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT02366494
- Acronym / sponsor ID
- 23842
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, treatment response, androgen deprivation therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 29 Apr 2015 (actual)
- Primary completion
- 11 May 2021 (actual)
- Study completion
- 11 May 2021 (actual)
- First posted
- 19 Feb 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.
Identify exosomal micro RNA that predict responses to ADT
Detailed description
- Identify novel exosomal RNA signatures at pretreatment that predict response to ADT. The study team will collect blood samples from patients with systemic disease pretreatment (at enrollment), three months post-treatment and at the time of progression of disease (or at two years post-ADT for patients still in remission at that time point) and then perform next-generation sequencing using serum exosomal RNAs derived from these patients. The investigators plan to identify exosomal RNAs signatures that change between pretreatment (at enrollment) and during treatment (at three months) and further explore the effect of these changes on disease response. The investigators also plan to compare exosomal RNA levels between patients relapse within the first two years versus those in remission at two years. Among patients with progression, the investigators plan to compare exosomal RNA signatures at progression of disease to signatures at pretreatment and during treatment.
- Validate exosomal RNA markers that predict response to ADT by real-time RT-PCR.
Secondary objectives: Selected RNAs, identified through the above process will be validated using real-time RT-PCR assay to test reproducibility of RNA sequencing results. The investigators expect to select and validate approximate five RNA markers that predict duration of response to ADT.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Androgen blockade | – | Drug: Bicalutamide, Drug: Leuprolide, Drug: Goserelin, Drug: TriptorelinAndrogen DeprivationTherapy or Complete Androgen Blockade |
| Hormonal Therapy and Chemotherapy | – | Drug: Bicalutamide, Drug: Leuprolide, Drug: Goserelin, Drug: Triptorelin, Drug: Docetaxel, Drug: Abiraterone, Drug: Apalutamide, Drug: EnzalutamideHormonal therapy, novel oral hormonal therapy (abiraterone/apalutamide/enzalutamide) and chemotherapy (docetaxel) |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men with systemic disease ( with biochemical relpase or metastaic disease)
Key inclusion criteria (7 listed)
- Histologically proven prostate cancer.
- Testosterone level >30ng/ml and at least 6 months since last dose of hormonal therapy.
- History/physical examination including a detailed description of the stage of prostate cancer within 8 weeks prior to registration.
- CT scan of abdomen and pelvis with IV contrast and bone scan should be performed within 8 weeks prior to registration.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
Key exclusion criteria (4 listed)
- Received hormonal therapy less than 6 months prior to registration.
- History of active secondary malignancy.
- Decline hormone therapy for prostate cancer.
- Current or previous treatment with 5-alpha reductase inhibitors within 6 months prior to enrollment.
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 |
|---|---|---|
| BicalutamideAlso: CasodexANDROGEN BLOCKADE | Drug | Androgen blockade, Hormonal Therapy and Chemotherapy |
| LeuprolideAlso: LupronANDROGEN BLOCKADE | Drug | Androgen blockade, Hormonal Therapy and Chemotherapy |
| GoserelinAlso: ZoladexANDROGEN BLOCKADE | Drug | Androgen blockade, Hormonal Therapy and Chemotherapy |
| TriptorelinAlso: TrelstarANDROGEN BLOCKADE | Drug | Androgen blockade, Hormonal Therapy and Chemotherapy |
| DocetaxelAlso: TaxotereChemo hormonal therapy | Drug | Hormonal Therapy and Chemotherapy |
| AbirateroneAlso: ZytigaChemo hormonal therapy | Drug | Hormonal Therapy and Chemotherapy |
| ApalutamideAlso: ErleadaNonsteroidal antiandrogen medication | Drug | Hormonal Therapy and Chemotherapy |
| EnzalutamideAlso: XtandiNonsteroidal antiandrogen medication | Drug | Hormonal Therapy and Chemotherapy |
Primary outcome
Identify five most prevalent exosomal microRNAs that predict response to androgen deprivation therapy based treatment.
Time frame: Up to two years
Two hundred to 300 microRNAs will be identified by RNA sequencing. This outcome measure will report the read count per million of the top-five most prevalent microRNAs that correlate with responses.
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 25 Nov 2024.
- Background: PubMed 17135641Taplin ME, Xie W, Bubley GJ, Ernstoff MS, Walsh W, Morganstern DE, Regan MM. Docetaxel, estramustine, and 15-month androgen deprivation for men with prostate-specific antigen progression after definitive local therapy for prostate cancer. J Clin Oncol. 2006 Dec 1;24(34):5408-13. doi: 10.1200/JCO.2006.06.6589.
- Results publication: PubMed 18309951Scher HI, Halabi S, Tannock I, Morris M, Sternberg CN, Carducci MA, Eisenberger MA, Higano C, Bubley GJ, Dreicer R, Petrylak D, Kantoff P, Basch E, Kelly WK, Figg WD, Small EJ, Beer TM, Wilding G, Martin A, Hussain M; Prostate Cancer Clinical Trials Working Group. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol. 2008 Mar 1;26(7):1148-59. doi: 10.1200/JCO.2007.12.4487.
- Results publication: PubMed 4625049Huggins C, Hodges CV. Studies on prostatic cancer. I. The effect of castration, of estrogen and androgen injection on serum phosphatases in metastatic carcinoma of the prostate. CA Cancer J Clin. 1972 Jul-Aug;22(4):232-40. doi: 10.3322/canjclin.22.4.232. No abstract available.
- 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.
Deepak Kilari, MD principal investigator
The Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Medical College of Wisconsin at 1 site in United States.
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 7 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 25 Nov 2024. 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 United States. 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?
Identify five most prevalent exosomal microRNAs that predict response to androgen deprivation therapy based treatment. (time frame: Up to two 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 NCT02366494, which also lists 3 linked publications.
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 25 Nov 2024.