Hormone Refractory Prostate CancerNCT02208583
Molecular Phenotype Changes and Personalized Treatment for CRPC
A study testing Docetaxel & Prednisone, DP & Targeted drugs and cisplatin & Etoposide in people with Hormone Refractory Prostate Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
To explore the molecular phenotypic changes and personalized treatment in castration-resistant prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hormone Refractory Prostate Cancer
- What is being tested?
- Docetaxel & Prednisone, DP & Targeted drugs and cisplatin & Etoposide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to Dec 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
- 18 Years and older;
- patients with CRPC according to European Association of Urology diagnostic criteria ;
- vital organs functions including bone marrow, heart, liver, kidney are normal;
- complete pathological specimens including newly diagnosed with prostate cancer and disease progress to CRPC: ① biopsies or surgical specimens (tissue bank or wax block preserved specimens) at diagnosis ; ② re-biopsy specimens,transurethral prostatectomy (TURP) specimens, metastases palliative surgical specimens (tissue bank or wax block preserved specimens) after progress to CRPC; ③ amount sufficient sample for DNA extraction and quality control by up to standard (a) Sample type: None RNA degradation and pollution-free DNA samples; (b) the amount of the sample (single): ≥ 250ng (using agilent liquid platform); (c) sample concentration: ≥ 50 ng / μl (using agilent liquid platform); (d) sample purity: OD 260/280 = 1.8 ~ 2.0 );
- Then we perform following tests when patients meet the above criteria: ①Histological analysis: Hematoxylin-eosin(HE) staining ②immunohistochemistry(IHC) staining ③ 48 carcinomas associated exon sequencing
- After performing the above test, enter treatment group ① Docetaxel \& Prednisone(DP) : with high PSA and no gene mutation; ② DP + targeted drugs: with high PSA and gene mutations; ③ cisplatin \& Etoposide(EP) : low PSA and no gene mutation; ④ EP + targeted drug: Low PSA and gene mutations.
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- All patients enrolled in draw peripheral blood samples 7.5ml and detect circulating tumor cells (CTC) , monitoring efficacy.
- 8. Willing and able to comply with the program during the study period. 9 before entering clinical trials to provide written informed consent form, and the patient has to know you can withdraw from the study at any time in the study, and without any loss.
- 10. Agrees to provide blood and tissue specimens. 11 expected survival of> 6 months 12.Karnofsky performance status (KPS)> 60; Eastern Cooperative Oncology Group(ECOG) score 0-2 13 signed informed consent form
Who cannot join
- other cancers
- cognitive inability and mental abnormalities
- other serious disease or condition
- severe, uncontrolled internal medicine and infectious diseases
- severe digestive disorder can not control
- severe electrolyte imbalance
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- active disseminated intravascular coagulation
- major organ failure, such as decompensated heart, lung, liver, kidney failure
- peripheral neuropathy symptoms, NCI grade> Ⅱ degree
- can not tolerate chemotherapy or refuse chemotherapy
- using the other test drug or participate other clinical trials
- can not oral drugs
- receiving chemotherapy, biological therapy, or other anti-cancer medicine intervals less than 4 weeks
- Researchers believe patients unsuitable (compliance, we should not follow-up)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Interventional Oncology, Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Wang HaiTao, Ph.D, +86-18630955984, peterrock2000@126.com
Wang HaiTao, Ph.D
About this study
Official title: Exploratory Study of Molecular Phenotype Changes and Personalized Treatment for Patients With Castration Resistant Prostate Cancer
To explore the molecular phenotypic changes and personalized treatment in castration-resistant prostate cancer.
Read the detailed description
This is a multi-center study to explore the molecular phenotypic changes in castration-resistant prostate cancer by histopathological,immunohistochemical and molecular analysis of cancer related genes in castration-resistant prostate cancer.After patient eligibility is determined, tumor tissue will be acquired from archival or transurethral resection or from re-biopsy specimens from patients with recurrence, visceral metastasis, bone metastases. According to the molecular phenotypic changes, personalized treatment were performed.
Participants will be screened with a full medical history and physical examination, blood and urine tests, and tumor imaging studies. The tumor specimens at diagnosis of prostate cancer should be needed for all the participants.
After assessing for the prostate specific antigen (PSA) level and the tumor molecular phenotypic features,participants will be separated into different treatment groups:
- Participants with "AR dependent" CRPC (generally with high PSA level and/or high AR expression) and with druggable gene mutations will receive Docetaxel/prednisone+Target drugs.
- Participants with "AR dependent" CRPC (generally with high PSA level and/or high AR expression) and without druggable gene mutations will receive Docetaxel/ Prednisone.
- Participants with "AR independent" CRPC (generally without AR expression and/or rapid progression with low PSA level) and with druggable gene mutations will receive Cisplatin/Etoposide+Target drugs.
- Participants with "AR independent" CRPC (generally without AR expression and/or rapid progression with low PSA level) and without druggable gene mutations will receive Cisplatin/Etoposide.
Participants with druggable gene mutations will receive the corresponding molecular targeted drugs.
Participants with epidermal growth factor receptor (EGFR) gene mutation will receive a drug called Gefitinib, which inhibits a protein called EGFR that is thought to be a key factor in the development and progression of some cancers.
Participants with B-type Raf kinase (BRAF) gene mutations will receive a drug called Vemurafenib, which inhibits a protein called mitogen-activated or extracellular signal-regulated protein kinase kinase (MEK) that is thought to be a key factor in the development and progression of some cancers.
Participants with v-akt murine thymoma viral oncogene homologue 1 (AKT1) gene mutations will receive a drug called Celecoxib, which inhibits a protein called v-akt murine thymoma viral oncogene homologue (AKT) that is thought to be a key factor in the development and progression of some cancers.
Participants who have erythroblastic leukemia viral oncogene homolog 2 (ERBB2) gene mutation will receive a drug called lapatinib, which inhibits some proteins that are thought to be key factors in the development and progression of some cancers.
Participants with PDGFRA gene mutations will receive a drug called sunitinib, which inhibits some proteins that are thought to be key factors in the development and progression of some cancers.
Participants with PIK3CA gene mutations will receive a drug called Everolimus, which inhibits a protein called AKT that is thought to be a key factor in the development and progression of some cancers.
- Conditions
- Hormone Refractory Prostate Cancer
- Being tested
- Docetaxel & Prednisone, DP & Targeted drugs, cisplatin & Etoposide, EP & Targeted drugs
- Keywords
- Molecular phenotypic；CRPC; personalized treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel & PrednisoneDrug
Also called Taxotere
Docetaxel \& Prednisone: Docetaxel 75mg/m2，d1;Prednisone 5mg，bid，d1-21
DP & Targeted drugsDrug
Also called Targeted drugs for PO
Docetaxel 75mg/m2，d1; Prednisone 5mg，bid，d1-21;Targeted drugs for PO. Participants with EGFR gene mutation will receive a drug called Gefitinib; Participants with BRAF gene mutations will receive a drug called Vemurafenib; Participants with AKT1 gene mutations will receive a drug called Celecoxib; Participants who have ERBB2 gene mutation will receive a drug called lapatinib; Participants with PDGFRA gene mutations will receive a drug called sunitinib; Participants with PIK3CA gene mutations will receive a drug called Everolimus
cisplatin & EtoposideDrug
Also called cisplatin and Etoposide for injection
cisplatin \& Etoposide:cisplatin 25mg/m2，d1-3; Etoposide 100 mg/m2，d1-3
EP & Targeted drugsDrug
Also called Targeted drugs for po
cisplatin 25mg/m2，d1-3; Etoposide 100 mg/m2，d1-3; Targeted drugs for po. Participants with EGFR gene mutation will receive a drug called Gefitinib; Participants with BRAF gene mutations will receive a drug called Vemurafenib; Participants with AKT1 gene mutations will receive a drug called Celecoxib; Participants who have ERBB2 gene mutation will receive a drug called lapatinib; Participants with PDGFRA gene mutations will receive a drug called sunitinib; Participants with PIK3CA gene mutations will receive a drug called Everolimus
| Study group | Role | What they receive |
|---|---|---|
| AR dependent CRPC | Active comparator | Assignment to Treatment Group based on druggable gene mutations analysis:
CRPC patients without druggable gene mutations: Docetaxel \& Prednisone; CRPC patients with druggable gene mutations: DP \& Targeted drugs Receives: Drug: Docetaxel & Prednisone; Drug: DP & Targeted drugs |
| AR independent CRPC | Active comparator | Assignment to Treatment Group based on druggable gene mutations analysis:
CRPC patients without druggable gene mutations: cisplatin \& Etoposide; CRPC patients with druggable gene mutations: EP \& Targeted drugs Receives: Drug: cisplatin & Etoposide; Drug: EP & Targeted drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular phenotypic changes after acquired resistance of hormonal therapy
The acquired resistance criteria is based on the european criteria for castration resistant prostate cancer.The molecular phenotypic changes including the following observations:1.histopathologic analysis for rebiopsy pathology in CRPC;2.Immunohistochemical staining for androgen receptor(AR),Ki-67,cluster of differentiation 56(CD56),Syn,P53, AURKA,N-myc,retinoblastoma susceptibility(RB), E-cadherin, vimentin;3.Targeting exom sequencing by TruSeq Amplicon Cancer Panel(TSACP) including the hotspot mutation for 48 cancer related genes.
Measured: 24 months
clinical progression free survival(cPFS)
cPFS is defined as the time from the start of treatment to disease progression.
Measured: 24months
Secondary outcomes (2)
Overall Survival(OS)
OS is defined as the time the time from the start of treatment to death.
Measured: 24 months
The relationship between molecular phenotypic changes and OS
The relationship between molecular phenotypic changes and OS means how the molecular phenotypic changes affects OS.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone Refractory 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wang HaiTao, Ph.D, Principal investigator, Department of Interventional Oncology, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02208583
- Sponsor's protocol ID
- E2014064
- Status last verified
- Jun 2014
- First submitted
- 29 Jul 2014
- Last updated
- 5 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Molecular Phenotype Changes and Personalized Treatment for Patients With Castration Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT02208583
- Acronym / sponsor ID
- E2014064
- Conditions
- Hormone Refractory Prostate Cancer
- Keywords
- Molecular phenotypic；CRPC; personalized treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 5 Aug 2014 (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.
To explore the molecular phenotypic changes and personalized treatment in castration-resistant prostate cancer.
Detailed description
This is a multi-center study to explore the molecular phenotypic changes in castration-resistant prostate cancer by histopathological,immunohistochemical and molecular analysis of cancer related genes in castration-resistant prostate cancer.After patient eligibility is determined, tumor tissue will be acquired from archival or transurethral resection or from re-biopsy specimens from patients with recurrence, visceral metastasis, bone metastases. According to the molecular phenotypic changes, personalized treatment were performed.
Participants will be screened with a full medical history and physical examination, blood and urine tests, and tumor imaging studies. The tumor specimens at diagnosis of prostate cancer should be needed for all the participants.
After assessing for the prostate specific antigen (PSA) level and the tumor molecular phenotypic features,participants will be separated into different treatment groups:
- Participants with "AR dependent" CRPC (generally with high PSA level and/or high AR expression) and with druggable gene mutations will receive Docetaxel/prednisone+Target drugs.
- Participants with "AR dependent" CRPC (generally with high PSA level and/or high AR expression) and without druggable gene mutations will receive Docetaxel/ Prednisone.
- Participants with "AR independent" CRPC (generally without AR expression and/or rapid progression with low PSA level) and with druggable gene mutations will receive Cisplatin/Etoposide+Target drugs.
- Participants with "AR independent" CRPC (generally without AR expression and/or rapid progression with low PSA level) and without druggable gene mutations will receive Cisplatin/Etoposide.
Participants with druggable gene mutations will receive the corresponding molecular targeted drugs.
Participants with epidermal growth factor receptor (EGFR) gene mutation will receive a drug called Gefitinib, which inhibits a protein called EGFR that is thought to be a key factor in the development and progression of some cancers.
Participants with B-type Raf kinase (BRAF) gene mutations will receive a drug called Vemurafenib, which inhibits a protein called mitogen-activated or extracellular signal-regulated protein kinase kinase (MEK) that is thought to be a key factor in the development and progression of some cancers.
Participants with v-akt murine thymoma viral oncogene homologue 1 (AKT1) gene mutations will receive a drug called Celecoxib, which inhibits a protein called v-akt murine thymoma viral oncogene homologue (AKT) that is thought to be a key factor in the development and progression of some cancers.
Participants who have erythroblastic leukemia viral oncogene homolog 2 (ERBB2) gene mutation will receive a drug called lapatinib, which inhibits some proteins that are thought to be key factors in the development and progression of some cancers.
Participants with PDGFRA gene mutations will receive a drug called sunitinib, which inhibits some proteins that are thought to be key factors in the development and progression of some cancers.
Participants with PIK3CA gene mutations will receive a drug called Everolimus, which inhibits a protein called AKT that is thought to be a key factor in the development and progression of some cancers.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AR dependent CRPC | Active comparator | Drug: Docetaxel & Prednisone, Drug: DP & Targeted drugsAssignment to Treatment Group based on druggable gene mutations analysis: CRPC patients without druggable gene mutations: Docetaxel \& Prednisone; CRPC patients with druggable gene mutations: DP \& Targeted drugs |
| AR independent CRPC | Active comparator | Drug: cisplatin & Etoposide, Drug: EP & Targeted drugsAssignment to Treatment Group based on druggable gene mutations analysis: CRPC patients without druggable gene mutations: cisplatin \& Etoposide; CRPC patients with druggable gene mutations: EP \& Targeted drugs |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 Years and older;
- patients with CRPC according to European Association of Urology diagnostic criteria ;
- vital organs functions including bone marrow, heart, liver, kidney are normal;
- complete pathological specimens including newly diagnosed with prostate cancer and disease progress to CRPC: ① biopsies or surgical specimens (tissue bank or wax block preserved specimens) at diagnosis ; ② re-biopsy specimens,transurethral prostatectomy (TURP) specimens, metastases palliative surgical specimens (tissue bank or wax block preserved specimens) after progress to CRPC; ③ amount sufficient sample for DNA extraction and quality control by up to standard (a) Sample type: None RNA degradation and pollution-free DNA samples; (b) the amount of the sample (single): ≥ 250ng (using agilent liquid platform); (c) sample concentration: ≥ 50 ng / μl (using agilent liquid platform); (d) sample purity: OD 260/280 = 1.8 ~ 2.0 );
- Then we perform following tests when patients meet the above criteria: ①Histological analysis: Hematoxylin-eosin(HE) staining ②immunohistochemistry(IHC) staining ③ 48 carcinomas associated exon sequencing
Key exclusion criteria (14 listed)
- other cancers
- cognitive inability and mental abnormalities
- other serious disease or condition
- can not tolerate chemotherapy or refuse chemotherapy
- using the other test drug or participate other clinical trials
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 |
|---|---|---|
| Docetaxel & PrednisoneAlso: TaxotereDocetaxel \& Prednisone: Docetaxel 75mg/m2，d1;Prednisone 5mg，bid，d1-21 | Drug | AR dependent CRPC |
| DP & Targeted drugsAlso: Targeted drugs for PODocetaxel 75mg/m2，d1; Prednisone 5mg，bid，d1-21;Targeted drugs for PO. Participants with EGFR gene mutation will receive a drug called Gefitinib; Participants with BRAF gene mutations will receive a drug called Vemurafenib; Participants with AKT1 gene mutations will receive a drug called Celecoxib; Participants who have ERBB2 gene mutation will receive a drug called lapatinib; Participants with PDGFRA gene mutations will receive a drug called sunitinib; Participants with PIK3CA gene mutations will receive a drug called Everolimus | Drug | AR dependent CRPC |
| cisplatin & EtoposideAlso: cisplatin and Etoposide for injectioncisplatin \& Etoposide:cisplatin 25mg/m2，d1-3; Etoposide 100 mg/m2，d1-3 | Drug | AR independent CRPC |
| EP & Targeted drugsAlso: Targeted drugs for pocisplatin 25mg/m2，d1-3; Etoposide 100 mg/m2，d1-3; Targeted drugs for po. Participants with EGFR gene mutation will receive a drug called Gefitinib; Participants with BRAF gene mutations will receive a drug called Vemurafenib; Participants with AKT1 gene mutations will receive a drug called Celecoxib; Participants who have ERBB2 gene mutation will receive a drug called lapatinib; Participants with PDGFRA gene mutations will receive a drug called sunitinib; Participants with PIK3CA gene mutations will receive a drug called Everolimus | Drug | AR independent CRPC |
Primary outcome
Molecular phenotypic changes after acquired resistance of hormonal therapy
Time frame: 24 months
The acquired resistance criteria is based on the european criteria for castration resistant prostate cancer.The molecular phenotypic changes including the following observations:1.histopathologic analysis for rebiopsy pathology in CRPC;2.Immunohistochemical staining for androgen receptor(AR),Ki-67,cluster of differentiation 56(CD56),Syn,P53, AURKA,N-myc,retinoblastoma susceptibility(RB), E-cadherin, vimentin;3.Targeting exom sequencing by TruSeq Amplicon Cancer Panel(TSACP) including the hotspot mutation for 48 cancer related genes.
clinical progression free survival(cPFS)
Time frame: 24months
cPFS is defined as the time from the start of treatment to disease progression.
2 secondary outcomes
Overall Survival(OS)
Time frame: 24 months
The relationship between molecular phenotypic changes and OS
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2014.
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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.
Wang HaiTao, Ph.D principal investigator
Department of Interventional Oncology, Tianjin Medical University Cancer Institute and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Docetaxel & Prednisone, DP & Targeted drugs and cisplatin & Etoposide in people with Hormone Refractory Prostate Cancer, run by Tianjin Medical University Cancer Institute and Hospital 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 9 inclusion and 14 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 5 Aug 2014. 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 Wang HaiTao, Ph.D (+86-18630955984, peterrock2000@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular phenotypic changes after acquired resistance of hormonal therapy (time frame: 24 months). 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 5 Aug 2014.