Prostate CancerPhase 2CHROMENCT04622761
Phase II Study of the Use of Neoadjuvant Cabazitaxel With Hormonal Treatment in Patients Operable Prostate Cancer, Assess the Efficacy and Toxicity of Cabazitaxel, and Explore Potential Predictive and Prognostic Markers of Clinical Outcome
A Phase 2 study testing Cabazitaxel in people with Prostate Cancer, run by The Clatterbridge Cancer Centre NHS Foundation Trust.
Trial summary
This study is evaluating the efficacy of cabazitaxel and hormonal treatment as neoadjuvant treatment for patients with clinically operable disease suitable for surgery, and a high risk of relapse after surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Cabazitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2021to 2 May 2026
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years
- ECOG performance status 0-1 (Appendix 2)
- Diagnosis of high risk prostate cancer as defined by one or more of the following: clinically T2c/T3, Gleason 8-10 and or PSA >10ng/ml
- Appropriate candidate for radical prostatectomy
- Life expectancy greater than 10 years
- Adequate organ function as evidenced by peripheral blood counts and serum chemistries at enrolment
- Ability and capacity to consent and comply with study and follow-up procedures
- Fit to receive chemotherapy
Who cannot join
- Locally advanced or metastatic disease
- Patients with a history of other previous malignancy except treated CIN or non melanomatous skin cancer
- Grade ≥2 peripheral neuropathy
- Grade ≥2 stomatitis
- History of severe hypersensitivity reaction (≥ grade 3) to taxane
- History of severe hypersensitivity reaction (≥ grade 3) to polysorbate 80 containing drugs
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- Other concurrent serious illness or medical conditions
- Inadequate organ and bone marrow function as evidenced by:
- Haemoglobin <10.0 g/dL
- Absolute neutrophil count <1.5 x 109/L
- Platelet count <100 x 109/L
- AST/SGOT and/or ALT/SGPT >1.5 xULN
- Total bilirubin >1.5 x ULN
- Serum creatinine >1.5 x ULN (if creatinine is 1.0 - 1.5 xULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance <60mL/min should be excluded - see Appendix 3)
- Uncontrolled diabetes mellitus
- Active uncontrolled gastro oesophageal reflux disease (GORD)
- Active infection requiring systemic antibiotic or antifungal medication
- Participation in another clinical trial with any investigational drug within 30 days prior to study enrolment
- Concurrent or planned treatment with strong inhibitors of cytochrome P450 3A4/5 (a 1-week washout period is necessary for patients who are already on these treatments - see Appendix 5 for a list of CYP3A inhibitors)
- Concurrent or planned treatment with strong inducers of cytochrome P450 3A4/5 (a 1-week washout period is necessary for patients who are already on these treatments) - see Appendix 4 for a list of CYP3A inducers)
- Contraindications or sensitivity to GCSF treatments
- History of myocardial infarction, unstable symptomatic ischemic heart disease, ongoing arrhythmias of Grade > 2 (NCI CTCAE, version 4.03), thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other cardiac condition (e.g., pericardial effusion restrictive cardiomyopathy) within 6 months prior to first dose of study drug. Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed.
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Trial locations and contacts
No sites are listed yet.
About this study
Official title: Phase II Study of the Use of Neoadjuvant Cabazitaxel With Hormonal Treatment in Patients With High Risk Operable Prostate Cancer, to Assess the Efficacy and Toxicity of Cabazitaxel, and, to Explore Potential Predictive and Prognostic Markers of Clinical Outcome
This study is evaluating the efficacy of cabazitaxel and hormonal treatment as neoadjuvant treatment for patients with clinically operable disease suitable for surgery, and a high risk of relapse after surgery
Read the detailed description
This study is evaluating the efficacy of cabazitaxel and hormonal treatment (LHRH analogues) as neoadjuvant treatment for patients with clinically operable disease suitable for surgery (no lymph node, visceral or bony metastases), and a high risk of relapse after surgery (5 year risk of relapse).
Patients will receive four cycles of neoadjuvant treatment (cabazitaxel treatment and 3 months LHRH treatment) unless there is evidence of disease progression, unacceptable toxicity or patient request to withdraw consent.
- Conditions
- Prostate Cancer
- Being tested
- Cabazitaxel
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabazitaxelDrug
Also called jevtana, XRP6258, RPR116258A
Patients will receive Cabazitaxel 25 mg/m2 * intravenously over one hour every 21 days (on Day 1 of each cycle). Treatment will be continued for 4 cycles unless disease progression, unacceptable toxicity or patient request. These patients will have surgery (radical prostatectomy) 4-86 weeks following treatment.
*Cabazitaxel dose should be capped at 50mg (BSA=2)
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Immediate surgery (radical prostatectomy) (standard care) |
| treatment | Experimental | 14 days prior to starting Cabazitaxel patients will take 50mg Bicalutamide once daily for 21 days.
7 days prior to starting Cabazitaxel patients will be given 3 months LHRH treatment via injection. The entire dose will be administered via one injection 7 days prior to starting Cabazitaxel. This may be either leuprorelin or goserelin acetate and should be given as per local practice.
At least 30 minutes prior to each administration of Cabazitaxel, patients will be administered IV premedication consisting of:
50mg Ranitidine 10mg Chlorphenamine 8mg Dexamethasone Daily from Day 1 until end of Cabazitaxel treatment patients will take 10mg Prednisolone once daily from Day 1 until end of Cabazitaxel treatment Day 1 of each cycle - Patients will receive Cabazitaxel 25 mg/m2 intravenously over one hour every 21 days (on Day 1 of each cycle). Treatment will be continued for 4 cycles. Receives: Drug: Cabazitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the efficacy activity of neoadjuvant Cabazitaxel chemotherapy and hormonal therapy in patients with high risk operable prostate cancer, measuring the reduction in treatment failure and comparing this to that obtained in the control arm
Treatment failure is defined as: PSA level ≥ 0.12ng/ml measured on at least two occasions (1 confirmatory sample) post-surgery within three years of follow-up or death related to prostate cancer or use of a salvage therapy or not undergoing surgery at all.)
Measured: through study completion, average 3 years
Secondary outcomes (7)
• To assess the efficacy of neoadjuvant Cabazitaxel chemotherapy and hormonal therapy, measuring the pathological and radiological response rates and comparing this to that obtained in a control arm of immediate surgery.
Pathological response rate assessed as per pTNM staging system Radiological response rates as defined in RECIST V1.1 Combined to give overall response rate
Measured: 3 year follow up
To assess the efficacy of neoadjuvant Cabazitaxel chemotherapy and hormonal therapy, assessing surgical margin involvement and comparing this to that obtained in a control arm of immediate surgery.
The proportion of patients with positive resection margin will be reported and compared across the treatment groups using Chi-square tests. Multivariable models using logistic regression techniques shall be used to adjust for key prognostic variables of interest.
Measured: 3 year follow up
To assess the efficacy of neoadjuvant Cabazitaxel chemotherapy and hormonal therapy, assessing lymph node involvement and comparing this to that obtained in a control arm of immediate surgery.
The proportion of patients with positive lymph nodes will be reported and compared across the treatment groups using Chi-square tests.
Measured: 3 year follow up
To assess the efficacy of neoadjuvant Cabazitaxel chemotherapy and hormonal therapy, measuring progression free survival and comparing this to that obtained in a control arm of immediate surgery.
Measured: 3 year follow up
• To assess the efficacy of neoadjuvant Cabazitaxel chemotherapy and hormonal therapy, measuring overall survival from time of randomisation to death and comparing this to that obtained in a control arm of immediate surgery.
Measured: 3 year follow up
To assess the efficacy of neoadjuvant Cabazitaxel chemotherapy and hormonal therapy, measuring surgical feasibility and comparing this to that obtained in a control arm of immediate surgery.
The proportion of patients with delays to surgery, perioperative morbidities, mortalities and surgical complications will be reported and compared across the treatment groups.
Measured: 3 year follow up
To assess the quality of life of patients receiving neoadjuvant Cabazitaxel chemotherapy and hormonal therapy and comparing this to quality of life patients in a control arm of immediate surgery using the EORTC QLQ-C30 version 3 questionnaire.
Responses to EORTC QLQ-C30 will be reported (median, IQR) according to global health status, the functional scales and symptom scales, by intervention group, and over time. Joint modelling or quality-adjusted survival analysis will be undertaken to allow a simultaneous assessment of quality of life and survival.
Measured: 3 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start15 Jan 2021 (estimated)
- Primary completion2 Nov 2025 (estimated)
- Study completion2 May 2026 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A two arm, phase II randomised multi-centre trial. 120 patients will be recruited to the trial. Patients will be randomised to a control arm of immediate surgery or a treatment arm in a ratio of 1:2 (control 40pts: treatment 80pts). Patients in the treatment arm will receive hormonal treatment and Cabazitaxel 25 mg/m2 day 1 intravenously over one hour every 21 days. Treatment will be continued for 4 cycles (3 months) unless disease progression, unacceptable toxicity or patient request.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Clatterbridge Cancer Centre NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Liverpool
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622761
- Sponsor's protocol ID
- RDD630
- Acronym
- CHROME
- Status last verified
- Nov 2020
- First submitted
- 29 Sep 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of the Use of Neoadjuvant Cabazitaxel With Hormonal Treatment in Patients With High Risk Operable Prostate Cancer, to Assess the Efficacy and Toxicity of Cabazitaxel, and, to Explore Potential Predictive and Prognostic Markers of Clinical Outcome
- ClinicalTrials.gov ID
- NCT04622761
- Acronym / sponsor ID
- CHROME / RDD630
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The Clatterbridge Cancer Centre NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Liverpool
- Study start
- 15 Jan 2021 (estimated)
- Primary completion
- 2 Nov 2025 (estimated)
- Study completion
- 2 May 2026 (estimated)
- First posted
- 10 Nov 2020 (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 study is evaluating the efficacy of cabazitaxel and hormonal treatment as neoadjuvant treatment for patients with clinically operable disease suitable for surgery, and a high risk of relapse after surgery
Detailed description
This study is evaluating the efficacy of cabazitaxel and hormonal treatment (LHRH analogues) as neoadjuvant treatment for patients with clinically operable disease suitable for surgery (no lymph node, visceral or bony metastases), and a high risk of relapse after surgery (5 year risk of relapse).
Patients will receive four cycles of neoadjuvant treatment (cabazitaxel treatment and 3 months LHRH treatment) unless there is evidence of disease progression, unacceptable toxicity or patient request to withdraw consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A two arm, phase II randomised multi-centre trial. 120 patients will be recruited to the trial. Patients will be randomised to a control arm of immediate surgery or a treatment arm in a ratio of 1:2 (control 40pts: treatment 80pts). Patients in the treatment arm will receive hormonal treatment and Cabazitaxel 25 mg/m2 day 1 intravenously over one hour every 21 days. Treatment will be continued for 4 cycles (3 months) unless disease progression, unacceptable toxicity or patient request.
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –Immediate surgery (radical prostatectomy) (standard care) |
| treatment | Experimental | Drug: Cabazitaxel14 days prior to starting Cabazitaxel patients will take 50mg Bicalutamide once daily for 21 days. 7 days prior to starting Cabazitaxel patients will be given 3 months LHRH treatment via injection. The entire dose will be administered via one injection 7 days prior to starting Cabazitaxel. This may be either leuprorelin or goserelin acetate and should be given as per local practice. At least 30 minutes prior to each administration of Cabazitaxel, patients will be administered IV premedication consisting of: 50mg Ranitidine 10mg Chlorphenamine 8mg Dexamethasone Daily from Day 1 until end of Cabazitaxel treatment patients will take 10mg Prednisolone once daily from Day 1 until end of Cabazitaxel treatment Day 1 of each cycle - Patients will receive Cabazitaxel 25 mg/m2 intravenously over one hour every 21 days (on Day 1 of each cycle). Treatment will be continued for 4 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged ≥18 years
- ECOG performance status 0-1 (Appendix 2)
- Diagnosis of high risk prostate cancer as defined by one or more of the following: clinically T2c/T3, Gleason 8-10 and or PSA >10ng/ml
- Appropriate candidate for radical prostatectomy
- Life expectancy greater than 10 years
Key exclusion criteria (23 listed)
- Locally advanced or metastatic disease
- Patients with a history of other previous malignancy except treated CIN or non melanomatous skin cancer
- Grade ≥2 peripheral neuropathy
- Grade ≥2 stomatitis
- History of severe hypersensitivity reaction (≥ grade 3) to taxane
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 |
|---|---|---|
| CabazitaxelAlso: jevtana, XRP6258, RPR116258APatients will receive Cabazitaxel 25 mg/m2 * intravenously over one hour every 21 days (on Day 1 of each cycle). Treatment will be continued for 4 cycles unless disease progression, unacceptable toxicity or patient request. These patients will have surgery (radical prostatectomy) 4-86 weeks following treatment. *Cabazitaxel dose should be capped at 50mg (BSA=2) | Drug | treatment |
Primary outcome
To assess the efficacy activity of neoadjuvant Cabazitaxel chemotherapy and hormonal therapy in patients with high risk operable prostate cancer, measuring the reduction in treatment failure and comparing this to that obtained in the control arm
Time frame: through study completion, average 3 years
Treatment failure is defined as: PSA level ≥ 0.12ng/ml measured on at least two occasions (1 confirmatory sample) post-surgery within three years of follow-up or death related to prostate cancer or use of a salvage therapy or not undergoing surgery at all.)
7 secondary outcomes
• To assess the efficacy of neoadjuvant Cabazitaxel chemotherapy and hormonal therapy, measuring the pathological and radiological response rates and comparing this to that obtained in a control arm of immediate surgery.
Time frame: 3 year follow up
To assess the efficacy of neoadjuvant Cabazitaxel chemotherapy and hormonal therapy, assessing surgical margin involvement and comparing this to that obtained in a control arm of immediate surgery.
Time frame: 3 year follow up
To assess the efficacy of neoadjuvant Cabazitaxel chemotherapy and hormonal therapy, assessing lymph node involvement and comparing this to that obtained in a control arm of immediate surgery.
Time frame: 3 year follow up
To assess the efficacy of neoadjuvant Cabazitaxel chemotherapy and hormonal therapy, measuring progression free survival and comparing this to that obtained in a control arm of immediate surgery.
Time frame: 3 year follow up
• To assess the efficacy of neoadjuvant Cabazitaxel chemotherapy and hormonal therapy, measuring overall survival from time of randomisation to death and comparing this to that obtained in a control arm of immediate surgery.
Time frame: 3 year follow up
To assess the efficacy of neoadjuvant Cabazitaxel chemotherapy and hormonal therapy, measuring surgical feasibility and comparing this to that obtained in a control arm of immediate surgery.
Time frame: 3 year follow up
To assess the quality of life of patients receiving neoadjuvant Cabazitaxel chemotherapy and hormonal therapy and comparing this to quality of life patients in a control arm of immediate surgery using the EORTC QLQ-C30 version 3 questionnaire.
Time frame: 3 year follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cabazitaxel in people with Prostate Cancer, run by The Clatterbridge Cancer Centre NHS Foundation Trust.
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 8 inclusion and 23 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 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Marie Maguire (0151 556 5321, maria.maguire2@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the efficacy activity of neoadjuvant Cabazitaxel chemotherapy and hormonal therapy in patients with high risk operable prostate cancer, measuring the reduction in treatment failure and comparing this to that obtained in the control arm (time frame: through study completion, average 3 years). 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 Jan 2021.