Castration-resistant Prostate CancerPhase 2STAMPNCT03696186
Selective Treatment According to Molecular Subtype of Prostate Cancer
A Phase 2 study testing Luminal type-1, Luminal type-2 and Neuroendocrine type-1 in people with Castration-resistant Prostate Cancer and Prostate Cancer Metastatic, run by Tianjin Medical University Second Hospital at 1 site in China.
Trial summary
This is an open-label study that includes three substudies of random distribution. First, a sample of the primary tumor will be obtained and will be analyzed by an immunohistochemical technique to determine several markers. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Castration-resistant Prostate Cancer, Prostate Cancer Metastatic
- What is being tested?
- Luminal type-1, Luminal type-2 and Neuroendocrine type-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2018to Aug 2023
- Phase
- Phase 2
- 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
- Participants who have given consent form;
- Patients with a confirmed diagnosis of mCRPC according to EAU 2018 guideline;
- Serum testosterone must reach castration level: <50 ng per deciliter;
- Participants with life expectancy of at least 6 months based on the Investigator's clinical judgment.
Who cannot join
- Participants who are allergic to contrast medium;
- Patients were excluded if they planned to receive additional concurrent anticancer therapies;
- Patients doesn't sign an informed consent form.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical Unversity Second Hospital
Tianjin, 300211
Rong Han, +86 022 8832 8677, miyansuo@126.com
Yuanjie Niu, MD,PhD
About this study
This is an open-label study that includes three substudies of random distribution. First, a sample of the primary tumor will be obtained and will be analyzed by an immunohistochemical technique to determine several markers. Depending on the expression of these markers, the patients will be characterize as group 1 (Luminal phenotype), group 2 (Neuroendocrine phenotype) or group 3 (Atypical phenotype) and a random assignment will be performed to standard or experimental treatment.
Read the detailed description
Metastatic castration-resistant prostate cancer (mCRPC) is a heterogenous disease with at least 3 intrinsic subtypes including luminal, neuroendocrine, and atypical phenotypes. Different subtypes have different prognosis and treatment sensitivity. Thus, it would be more suitable to administer different therapy in different subtypes. Therefore, the investigators designed this phase 2 randomized clinical trial to explore potential effective regimens in variable subtypes of mCRPC. Patients were first classified into Luminal type, Neuroendocrine type and Atypical type by immunohistochemistry exam of FKBP5/AR-WT/AR-v7/CgA/SYN/YAP1 in core needle biopsy and then randomized to received either standard or experimental treatment.
- Group 1 (Luminal type): Standard treatment: Goserelin (3.75mg, once every 4 weeks)+Docetaxel (75 mg/m2 on day 1 every 3 weeks)+Prednisone (5 mg, twice daily) Experimental treatment: Goserelin (3.75mg, once every 4 weeks)+Abiraterone (1000 mg, once daily)+Prednisone (5 mg, twice daily)
- Group 2 (Neuroendocrine type): Standard treatment: Goserelin (3.75mg, once every 4 weeks)+Docetaxel (75 mg/m2 on day 1 every 3 weeks)+Prednisone (5 mg, twice daily) Experimental treatment: Goserelin (3.75mg, once every 4 weeks)+Carboplatin (area under the curve 5 on day 1 every 3 weeks)+Docetaxel (75 mg/m2 on day 1 every 3 weeks)+Prednisone (5 mg, twice daily)
- Group 3 (Atypical type):
Standard treatment: Goserelin (3.75mg, once every 4 weeks)+Docetaxel (75 mg/m2 on day 1 every 3 weeks)+Prednisone (5 mg, twice daily)
Experimental treatment: Goserelin (3.75mg, once every 4 weeks)+Abiraterone (1000 mg, once daily)+targeted therapy according to next Generation Sequencing (NGS)+Prednisone (5 mg, twice daily); or Goserelin (3.75mg, once every 4 weeks)+Abiraterone alone+Prednisone (5 mg, twice daily) if no druggable gene mutation detected. The detailed Individual treatment see below.
The duration of chemotherapy is 6-10 cycles. Primary endpoint is the overall survival (OS) in each subtypes. Secondary endpoints include progression free survival (PFS), PSA response rate and safety. Tissue samples and blood samples will be collected at baseline and during treatment. There will be exploratory biomarkers analyses to identify predictive markers for efficacy in every subtypes.
Targeted Therapy: Participants with druggable gene mutations will receive the corresponding molecular targeted drugs.
- Participants with epidermal growth factor receptor (EGFR) gene mutation will receive 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 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 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 Lapatinib, which inhibits some proteins that are thought to be key factors in the development and progression of some cancers.
- Participants with PDGFRA/PDGFRB gene mutations will receive 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 Everolimus, which inhibits a protein called AKT that is thought to be a key factor in the development and progression of some cancers.
- Participants with DNA-repair gene defects will receive Olaparib, which inhibits poly ADP ribose polymerase (PARP).
- Being tested
- Luminal type-1, Luminal type-2, Neuroendocrine type-1, Neuroendocrine type-2, Atypical type-1
- Keywords
- Metastatic Castration-resistant Prostate Cancer, Cancer Subtype, Chemotherapy, Target Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Luminal type-1Drug
Goserelin (3.75mg, once every 4 weeks)+Docetaxel (75 mg/m2 on day 1 every 3 weeks)+Prednisone (5 mg, twice daily)
Luminal type-2Drug
Goserelin (3.75mg, once every 4 weeks)+Abiraterone (1000 mg, once daily)+Prednisone (5 mg, twice daily)
Neuroendocrine type-1Drug
Goserelin (3.75mg, once every 4 weeks)+Docetaxel (75 mg/m2 on day 1 every 3 weeks)+Prednisone (5 mg, twice daily)
Neuroendocrine type-2Drug
Goserelin (3.75mg, once every 4 weeks)+Carboplatin (area under the curve 5 on day 1 every 3 weeks)+Docetaxel (75 mg/m2 on day 1 every 3 weeks)+Prednisone (5 mg, twice daily)
Atypical type-1Drug
Goserelin (3.75mg, once every 4 weeks)+Docetaxel (75 mg/m2 on day 1 every 3 weeks)+Prednisone (5 mg, twice daily)
Atypical type-2Drug
Goserelin (3.75mg, once every 4 weeks)+Abiraterone (1000 mg, once daily)+ targeted therapy according to next Generation Sequencing (NGS)+ Prednisone (5 mg, twice daily), or Goserelin (3.75mg, once every 4 weeks)+Abiraterone+ Prednisone (5 mg, twice daily) if no druggable gene mutation detected.
| Study group | Role | What they receive |
|---|---|---|
| Luminal type-1 | Active comparator | Standard treatment Receives: Drug: Luminal type-1 |
| Luminal type-2 | Experimental | Experimental treatment Receives: Drug: Luminal type-2 |
| Neuroendocrine type-1 | Active comparator | Standard treatment Receives: Drug: Neuroendocrine type-1 |
| Neuroendocrine type-2 | Experimental | Experimental treatment Receives: Drug: Neuroendocrine type-2 |
| Atypical type-1 | Active comparator | Standard treatment Receives: Drug: Atypical type-1 |
| Atypical type-2 | Experimental | Experimental treatment Receives: Drug: Atypical type-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
OS was defined as the duration from the initiation of treatment to death of any cause
Measured: Up to 40 months
Secondary outcomes (3)
PSA-Progression free survival (pPFS)
PSA progression was defined as an increase in the PSA level of 25% or more above the nadir (and by≥2 ng/ml), with confirmation of 4 or more weeks later
Measured: Up to 40 months
Radiographic progression free survival (rPFS)
rPFS was defined 1) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 criteria; or 2) as at least two new lesions on first post-treatment bone scan, with at least two additional lesions on the next bone scan
Measured: Up to 40 months
PSA response rate
PSA response is defined as ≥ 50% decline in PSA level from baseline, maintained for≥ 4 weeks
Measured: Up to 40 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start1 Aug 2018
- Primary completionAug 2022 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Castration-resistant 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Second Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03696186
- Sponsor's protocol ID
- STAMP
- Acronym
- STAMP
- Status last verified
- Oct 2018
- First submitted
- 3 Oct 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Treatment According to Molecular Subtype of Prostate Cancer
- ClinicalTrials.gov ID
- NCT03696186
- Acronym / sponsor ID
- STAMP / STAMP
- Keywords
- Metastatic Castration-resistant Prostate Cancer, Cancer Subtype, Chemotherapy, Target Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Tianjin Medical University Second HospitalUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 4 Oct 2018 (actual)
- 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 is an open-label study that includes three substudies of random distribution. First, a sample of the primary tumor will be obtained and will be analyzed by an immunohistochemical technique to determine several markers. Depending on the expression of these markers, the patients will be characterize as group 1 (Luminal phenotype), group 2 (Neuroendocrine phenotype) or group 3 (Atypical phenotype) and a random assignment will be performed to standard or experimental treatment.
Detailed description
Metastatic castration-resistant prostate cancer (mCRPC) is a heterogenous disease with at least 3 intrinsic subtypes including luminal, neuroendocrine, and atypical phenotypes. Different subtypes have different prognosis and treatment sensitivity. Thus, it would be more suitable to administer different therapy in different subtypes. Therefore, the investigators designed this phase 2 randomized clinical trial to explore potential effective regimens in variable subtypes of mCRPC. Patients were first classified into Luminal type, Neuroendocrine type and Atypical type by immunohistochemistry exam of FKBP5/AR-WT/AR-v7/CgA/SYN/YAP1 in core needle biopsy and then randomized to received either standard or experimental treatment.
- Group 1 (Luminal type): Standard treatment: Goserelin (3.75mg, once every 4 weeks)+Docetaxel (75 mg/m2 on day 1 every 3 weeks)+Prednisone (5 mg, twice daily) Experimental treatment: Goserelin (3.75mg, once every 4 weeks)+Abiraterone (1000 mg, once daily)+Prednisone (5 mg, twice daily)
- Group 2 (Neuroendocrine type): Standard treatment: Goserelin (3.75mg, once every 4 weeks)+Docetaxel (75 mg/m2 on day 1 every 3 weeks)+Prednisone (5 mg, twice daily) Experimental treatment: Goserelin (3.75mg, once every 4 weeks)+Carboplatin (area under the curve 5 on day 1 every 3 weeks)+Docetaxel (75 mg/m2 on day 1 every 3 weeks)+Prednisone (5 mg, twice daily)
- Group 3 (Atypical type):
Standard treatment: Goserelin (3.75mg, once every 4 weeks)+Docetaxel (75 mg/m2 on day 1 every 3 weeks)+Prednisone (5 mg, twice daily)
Experimental treatment: Goserelin (3.75mg, once every 4 weeks)+Abiraterone (1000 mg, once daily)+targeted therapy according to next Generation Sequencing (NGS)+Prednisone (5 mg, twice daily); or Goserelin (3.75mg, once every 4 weeks)+Abiraterone alone+Prednisone (5 mg, twice daily) if no druggable gene mutation detected. The detailed Individual treatment see below.
The duration of chemotherapy is 6-10 cycles. Primary endpoint is the overall survival (OS) in each subtypes. Secondary endpoints include progression free survival (PFS), PSA response rate and safety. Tissue samples and blood samples will be collected at baseline and during treatment. There will be exploratory biomarkers analyses to identify predictive markers for efficacy in every subtypes.
Targeted Therapy: Participants with druggable gene mutations will receive the corresponding molecular targeted drugs.
- Participants with epidermal growth factor receptor (EGFR) gene mutation will receive 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 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 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 Lapatinib, which inhibits some proteins that are thought to be key factors in the development and progression of some cancers.
- Participants with PDGFRA/PDGFRB gene mutations will receive 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 Everolimus, which inhibits a protein called AKT that is thought to be a key factor in the development and progression of some cancers.
- Participants with DNA-repair gene defects will receive Olaparib, which inhibits poly ADP ribose polymerase (PARP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Luminal type-1 | Active comparator | Drug: Luminal type-1Standard treatment |
| Luminal type-2 | Experimental | Drug: Luminal type-2Experimental treatment |
| Neuroendocrine type-1 | Active comparator | Drug: Neuroendocrine type-1Standard treatment |
| Neuroendocrine type-2 | Experimental | Drug: Neuroendocrine type-2Experimental treatment |
| Atypical type-1 | Active comparator | Drug: Atypical type-1Standard treatment |
| Atypical type-2 | Experimental | Drug: Atypical type-2Experimental treatment |
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)
- Participants who have given consent form;
- Patients with a confirmed diagnosis of mCRPC according to EAU 2018 guideline;
- Serum testosterone must reach castration level: <50 ng per deciliter;
- Participants with life expectancy of at least 6 months based on the Investigator's clinical judgment.
Key exclusion criteria (3 listed)
- Participants who are allergic to contrast medium;
- Patients were excluded if they planned to receive additional concurrent anticancer therapies;
- Patients doesn't sign an informed consent form.
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 |
|---|---|---|
| Luminal type-1Goserelin (3.75mg, once every 4 weeks)+Docetaxel (75 mg/m2 on day 1 every 3 weeks)+Prednisone (5 mg, twice daily) | Drug | Luminal type-1 |
| Luminal type-2Goserelin (3.75mg, once every 4 weeks)+Abiraterone (1000 mg, once daily)+Prednisone (5 mg, twice daily) | Drug | Luminal type-2 |
| Neuroendocrine type-1Goserelin (3.75mg, once every 4 weeks)+Docetaxel (75 mg/m2 on day 1 every 3 weeks)+Prednisone (5 mg, twice daily) | Drug | Neuroendocrine type-1 |
| Neuroendocrine type-2Goserelin (3.75mg, once every 4 weeks)+Carboplatin (area under the curve 5 on day 1 every 3 weeks)+Docetaxel (75 mg/m2 on day 1 every 3 weeks)+Prednisone (5 mg, twice daily) | Drug | Neuroendocrine type-2 |
| Atypical type-1Goserelin (3.75mg, once every 4 weeks)+Docetaxel (75 mg/m2 on day 1 every 3 weeks)+Prednisone (5 mg, twice daily) | Drug | Atypical type-1 |
| Atypical type-2Goserelin (3.75mg, once every 4 weeks)+Abiraterone (1000 mg, once daily)+ targeted therapy according to next Generation Sequencing (NGS)+ Prednisone (5 mg, twice daily), or Goserelin (3.75mg, once every 4 weeks)+Abiraterone+ Prednisone (5 mg, twice daily) if no druggable gene mutation detected. | Drug | Atypical type-2 |
Primary outcome
Overall survival (OS)
Time frame: Up to 40 months
OS was defined as the duration from the initiation of treatment to death of any cause
3 secondary outcomes
PSA-Progression free survival (pPFS)
Time frame: Up to 40 months
Radiographic progression free survival (rPFS)
Time frame: Up to 40 months
PSA response rate
Time frame: Up to 40 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Luminal type-1, Luminal type-2 and Neuroendocrine type-1 in people with Castration-resistant Prostate Cancer and Prostate Cancer Metastatic, run by Tianjin Medical University Second 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 4 inclusion and 3 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 9 Oct 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Shimiao Zhu, MD,PhD (+86 137 5243 6539, zhushimiao@tijmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: Up to 40 months). 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 9 Oct 2018.