CTRI/2024/06/068435招募中3 期
A Randomized, 2 cohort, Double blind, Placebo controlled, Phase III Study of AZD5305 in Combination with Physicians Choice New Hormonal Agents in Patients with HRRm and non HRRm Metastatic Castration Sensitive Prostate Cancer EvoPAR Prostate01
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,800
- 试验地点
- 12
- 主要终点
- (BRCAm and Non HRRm cohort)
研究概览
简要总结
This is a Phase III, 2-cohort, 2-arm, parallel-group, randomised, double-blind, placebo-controlled, multicentre, global study, assessing the efficacy and safety of AZD5305 + physician’s choice New hormonal agent (NHA ) compared with placebo + physician’s choice NHA in participants with Metastatic castration-sensitive prostate cancer (mCSPC) with and without Homologous recombination repair (mutation).Study details include:
· The study duration will be up to 90 months.
Study Cohorts, Arms, and Duration:
The study will have 4 periods: HRRm testing, screening, treatment, and follow-up:
• Potential participants will undergo prospective central HRRm testing, which may occur prior to the main screening period based on a separate informed consent (HRRm testing informed consent form). Local HRRm results will not be acceptable. HRRm testing must be completed and have a known result prior to randomisation. Participants will be allocated to 1 of the 2 cohorts (HRRm or Non-HRRm) prior to randomisation to study intervention based on the result of central HRRm testing. Treatment with ADT can be commenced while awaiting HRRm test results, as long as participants are randomised within 14 days to 4 months after start of ADT and no evidence of disease progression is found. It is recommended that results from HRRm testing are available prior to screening, however if necessary HRRm testing and the screening period can be performed in parallel.
• The screening period will commence once consent is obtained for the main study and will be up to 28 days.
· In both cohorts, participants will be randomised in a 1:1 ratio to one of the following intervention groups:
− AZD5305 60 mg + physician’s choice NHA: during the treatment period, participants will receive AZD5305 60 mg orally once daily in combination with physician’s choice NHA in cycles of 28 days.
− Placebo + physician’s choice NHA: during the treatment period, participants will receive placebo orally once daily in combination with physician’s choice NHA in cycles of 28 days.
· Physician’s choice NHA includes:
− 1000 mg abiraterone orally once daily with 5 mg prednisolone or prednisone, or
· 600 mg darolutamide orally twice daily, or
− 160 mg enzalutamide orally once daily
Randomised participants will continue treatment with AZD5305/placebo in combination with physician’s choice NHA until investigator-assessed disease progression by RECIST (Response Evaluation Criteria in Solid Tumours) version 1.1 (soft tissue lesions) and/or Prostate Cancer Working Group 3 (PCWG3) (bone lesions), unacceptable toxicity occurs, or the participant withdraws consent. The on-treatment visit frequency will be weekly to Q4W
• The treatment period will continue until investigator-assessed disease progression by RECIST 1.1 and/or PCWG3 progression criteria, unacceptable toxicity occurs, or the participant withdraws consent.
• The follow-up period will start after study intervention discontinuation (ie, after both AZD5305/placebo and NHA have been discontinued).
Follow-up of Participants Post Discontinuation of Study Intervention:
After study intervention discontinuation, all participants will undergo a treatment discontinuation visit (within 7 days of discontinuation) and will be followed up for safety assessments 30 days after their last dose of study intervention (ie, the safety follow-up visit).
Participants who have discontinued study intervention in the absence of RECIST 1.1 or. PCWG3-defined radiographic progression by investigator assessment will be followed up with tumour assessments according to the Schedule of Activities (SoA) until investigator-assessed RECIST 1.1 and/or PCWG3-defined disease progression or death, regardless of whether or not the participant started a subsequent anticancer therapy, unless they have withdrawn consent to all study-related assessments.
In addition, after the study intervention discontinuation and safety follow-up visit all participants will be followed up for survival status after study intervention discontinuation every 16 weeks (± 14 days) until death, withdrawal of consent, or the data cut-off (DCO) for the final analysis, whichever comes first, as per the schedule of assessment . Long-term survival follow-up data may be collected in the electronic data capture system for up to approximately 2 years after the final formal overall survival (OS) analysis DCO, to allow further exploratory analysis of OS. Participants who discontinue treatment and are in long-term follow-up (after final analysis DCO) should continue survival assessments every 16 weeks during the long-term survival follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Male
入选标准
- •Inclusion criteria Type of Participant and Disease Characteristics 1 Histologically documented prostate adenocarcinoma which is de novo or recurrent and castration-sensitive.
- •Participants with pathologic features of small cell, neuroendocrine, sarcomatoid, spindle cell, or signet cell histology are not eligible.
- •2 Metastatic disease as documented by the investigator prior to randomisation, with clear evidence of 1 bone lesion (defined as one lesion with positive uptake on bone scan) and/or 1 soft tissue lesion (measurable and/or non-measurable) that can be accurately assessed at baseline and is suitable for repeated assessment with CT and/or MRI.
- •Participants with metastatic disease identified by PSMA-PET only, will not be eligible.
- •Participants with disease limited to regional pelvic lymph nodes only are not eligible.
- •3 Participant is receiving ADT with a GnRH analogue or has undergone bilateral orchiectomy starting 14 days and 4 months prior to randomisation with no radiographic evidence of disease progression or rising PSA levels prior to first day of dosing.
- •Participant must remain on ADT throughout the study and be a candidate for treatment with an NHA.
- •Combination with first generation AR antagonists to counter testosterone flare is permitted until randomisation.
- •Note: Due to the interaction between relugolix and enzalutamide, this combination of ADT and NHA is not allowed.
- •Relugolix is otherwise permitted.
- •4 ECOG performance status of 0 or 1 with no deterioration over the 2 weeks prior to randomisation.
- •5 Minimum life expectancy of 6 months.
- •6 Provision of a FFPE tumour tissue sample and a blood sample for ctDNA as specified in the Laboratory Manual refer to Section 8.8 and to Table
- •7 Confirmed HRRm status by central tumour tissue and/or ctDNA test is required to determine cohort eligibility as described below: (a) Participants will be considered eligible for the HRRm Cohort if a loss of function mutation (deleterious/pathogenic or suspected deleterious/likely pathogenic in at least one of the genes BRCA1, BRCA2, ATM, CDK12, PALB2, RAD51B, RAD51C, RAD51D, and BARD1) is detected by either central tumour tissue or central ctDNA test, ie, a positive HRRm result reported by one assay (tissue or ctDNA) is sufficient irrespective of the result of the other assay.
- •(b) Participants will be considered eligible for the Non-HRRm Cohort if no gene mutation (in any of BRCA1, BRCA2, ATM, CDK12, PALB2, RAD51B, RAD51C, RAD51D, and BARD1) is detected by either tumour tissue or ctDNA test and a participant must have a non-HRRm tumour tissue test result.
- •Participants without a valid non-HRRm tumour tissue result will not be eligible for randomisation into the Non-HRRm Cohort.
- •For details see Table 7.
排除标准
- •Exclusion criteria Medical Conditions 1 Participants with a history of MDS AML or with features suggestive of MDS AML as determined by prior diagnostic investigation.
- •Specific screening for MDS AML is not required.
- •2 Participants with any known predisposition to bleeding eg, active peptic ulceration, recent within 6 months haemorrhagic stroke, proliferative diabetic retinopathy.
- •3 Any history of persisting 2 weeks severe cytopenia due to any cause eg, absolute neutrophil count 0.5 109 L or platelets 50 109 L 4 Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD5305 and/or the assigned NHA.
- •5 History of another primary malignancy, with the following exceptions: Adequately resected non-melanoma skin cancer.
- •Curatively treated in situ disease.
- •Malignancy treated with curative intent 3 years before the first dose of study intervention, and with no known active disease during the intervening time period.
- •6 Persistent toxicities CTCAE Grade 2 caused by previous anticancer therapy.
- •Participants with side effects that are not reasonably expected to affect the safety of the participant on study intervention in the opinion of the investigator eg, ADT-related side effects may be included if agreed with the Study Clinical Lead 7 Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.
- •A minimum of 2 weeks must have elapsed between the end of brain radiotherapy and signing the main study ICF.
- •8 Any of the following cardiac criteria: Mean resting corrected QT interval QTcF 470 milliseconds obtained from triplicate ECGs and averaged, recorded 5 minutes apart.
- •Congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives.
- •9 History of arrhythmia multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia, which is symptomatic or requires treatment CTCAE Grade 3, symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia.
- •Participants with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers may be permitted upon discussion with the AstraZeneca study physician 10 Other cardiovascular disease as defined by any of the following: Symptomatic heart failure as defined by New York Heart Association class
- •Acute coronary syndrome/acute myocardial infarction, unstable angina pectoris, coronary intervention procedure with percutaneous coronary intervention or coronary artery bypass grafting within 6 months prior to randomisation.
- •Cardiomyopathy of any aetiology Presence of clinically significant valvular heart disease.
- •Participants with symptomatic hypotension at screening.
- •Uncontrolled hypertension despite medical management.
- •11 Evidence of active and uncontrolled hepatitis B and/or hepatitis C.
- •Screening for hepatitis B and hepatitis C is not required.
- •Participants previously exposed to hepatitis B or hepatitis C are eligible if they meet one of the following criteria: a Are negative for HBsAg and anti-HBc or b Are HBsAg and anti-HBc chronic hepatitis B, and meet conditions i to iii below: HBV DNA viral load 2000 IU L.
- •Have normal aminotransferase values, or, if liver metastases are present, abnormal aminotransferase, with a result of AST, ALT 3 ULN, which are not attributable to HBV infection.
- •Start antiviral treatment at least 2 weeks prior to the first dose of study intervention and maintain antiviral treatment during the interventional period.
- •For permitted concomitant therapies, refer to Appendix I.
- •c Are anti-HBc positive, HBsAg negative, and have HBV DNA 2000 IU L.
- •d Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- •NOTE: Inclusion of this group of participants should be carefully considered if participant has no access to hepatology service and/or is currently in need of antiviral treatments.
- •Evidence of active and uncontrolled HIV infection.
- •Participants with controlled HIV need to meet the following criteria: undetectable viral RNA load less than 400 copies mL in the last 4 weeks prior to first dose of study intervention, CD4 count of 350 cells µL, no history of AIDS defining opportunistic infection within the past 12 months, and stable on the same anti-HIV medications as permitted in Appendix I for at least 6 months.
- •Screening for HIV is not required.
- •Active tuberculosis infection clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice.
- •Major surgical procedure excluding placement of vascular access or significant traumatic injury within 4 weeks of the first dose of study intervention or an anticipated need for major surgery during the study.
- •Participants should have fully recovered from any clinically significant AEs.
- •As judged by the investigator, any other evidence of diseases, such as severe or uncontrolled systemic diseases or active uncontrolled infections, including but not limited to uncontrolled major seizure disorder, active bleeding diseases, superior vena cava syndrome, or history of allogenic organ transplant, which, in the investigator’s opinion, makes it undesirable for the participant to participate in the study or would jeopardise compliance with the protocol.
- •16 Any prior treatment with a PARP inhibitor or platinum chemotherapy.
- •17 Any prior treatment with a GnRH analogue or NHA.
- •The following exceptions are permitted: 4 months ADT for metastatic disease per inclusion criterion
- •For localised disease and so long as there was 12 months between completion of therapy and subsequent recurrence: ADT for a maximum of 39 months note: for injectable depot preparations of ADT, completion of therapy is defined as last dose plus one times the dosing interval eg, 12 weeks for goserelin 10.8 mg.
- •NHA for a maximum of 30 months.
- •Radiation therapy for example radiation therapy to the prostate for participants with low volume metastatic disease or palliative radiation therapy to treat symptoms resulting from metastatic disease.
- •Radiation therapy needs to have been completed 4 weeks prior to randomisation for wide field radiation therapy and 2 weeks for limited field radiation therapy.
- •Participants should have fully recovered from any clinically significant adverse events.
- •Surgical therapy to treat symptoms from metastatic disease if it was completed at least 4 weeks prior to first day of dosing and participant fully recovered from any clinically significant AEs. 19 Prior treatment within 14 days with blood product support or growth factor support.
- •Initiation of treatment with a bisphosphonate or denosumab for the management of bone metastasis 28 days prior to randomisation.
- •Participants should be either on a stable dose of such agents for 28 days prior to randomisation or agree not to initiate such therapy until radiographic progression is documented.
- •Bisphosphonates and denosumab at doses for prevention of osteoporosis are allowed.
结局指标
主要结局
(BRCAm and Non HRRm cohort)
时间窗: RECIST 1.1 is to be assessment at screening, and Every 16 weeks (± 14 days) from randomisation until RECIST 1.1 and/or PCWG3-defined radiographic PD. | rPFS is defined as the time from randomisation to radiographic progression, as assessed by the investigator per RECIST 1.1 (soft tissue) and/or PCWG3 criteria (bone), or, death due to any cause.
Radiographic progression-free survival (rPFS) in participants with mCSPC
时间窗: RECIST 1.1 is to be assessment at screening, and Every 16 weeks (± 14 days) from randomisation until RECIST 1.1 and/or PCWG3-defined radiographic PD. | rPFS is defined as the time from randomisation to radiographic progression, as assessed by the investigator per RECIST 1.1 (soft tissue) and/or PCWG3 criteria (bone), or, death due to any cause.
次要结局
- To demonstrate superiority of AZD5305 physician s choice NHA relative to placebo physicians choice NHA by assessment of radiographic progression-free survival rPFS in participants with mCSPC(rPFS is defined as the time from randomisation to radiographic progression, as assessed by the investigator per RECIST 1.1 soft tissue and or PCWG3 criteria bone, or, death due to any cause.)
- To demonstrate the effectiveness of AZD5305 physicians choice NHA relative to placebo physicians choice NHA by assessment of time to first subsequent therapy or death TFST in participants with mCSPC(TFST is defined as the time from randomisation to the start date of the first subsequent anticancer therapy after discontinuation of randomised treatment, or death due to any cause.The analysis will include all randomised participants in the relevant subpopulation cohort as randomised. All events will be included, regardless of progression status.The measure of interest is the HR of TFST)
- To demonstrate the effectiveness of AZD5305 physicians choice NHA relative to placebo physicians choice NHA by assessment of symptomatic skeletal event free survival SSEF S in participants with mCSPC(SSE FS is defined as the time from randomisation to the earliest of the following)
- To demonstrate the effectiveness of AZD5305 physicians choice NHA relative to placebo physicians choice NHA by assessment of time to the first castration resistant event TTCR in participants with mCSPC(TTCR is defined as the time from randomisation to the first castration-resistant event radiographic disease progression per RECIST 1.1 soft tissue and or PCWG3 criteria bone, PSA progression per PCWG3, or SSE, PSA progression per PCWG3, or SSE, whichever occurs first, with castrate levels of testosterone below 50 ng dL.The analysis will include all randomised participants in the relevant subpopulation cohort as randomised. All events will be included, regardless of progression status)
- To demonstrate the effectiveness of AZD5305 physicians choice NHA relative to placebo physicians choice NHA by assessment of time to pain progression TTPP in participants with mCSPC(TTPP is defined as the time from randomisation to clinically meaningful pain progression based on a 2 point increase from baseline in the Brief Pain Inventory Short Form BPI SF Item 3 worst pain in 24 hours score and or initiation of increase in opioid analgesic use.The analysis will include all randomised participants in the relevant subpopulation cohort as randomised. All events will be included, regardless of progression status.The measure of interest is the HR of TTPP)
- To demonstrate the effectiveness of AZD5305 physicians choice NHA relative to placebo physicians choice NHA by assessment of time to deterioration in urinary symptoms TTDUS in participants with mCSPC(TTDUS is defined as the time from randomisation to deterioration in European Organisation for Research and Treatment of Cancer EORTC Quality of Life Prostate Questionnaire Urinary Symptoms QLQ PR25 US subscale scores.The analysis will include all randomised participants in the relevant subpopulationcohort as randomised. All events will be included, regardless of progression status.The measure of interest is the HR of TTDUS)
- To demonstrate the effectiveness of AZD5305 physicians choice NHA relative to placebo physicians choice NHA by assessment of time to deterioration in fatigue TTDF in participants with mCSPC(TTDF is defined as the time from randomisation to deterioration in Patient Reported Outcomes Measurement Information System PROMIS Fatigue Short Form 7A scores.The analysis will include all randomised participants in the relevant subpopulation cohort as randomised. All events will be included, regardless of progression status.The measure of interest is the HR of TTDF)
- To demonstrate the effectiveness of AZD5305 physicians choice NHA relative to placebo physicians choice NHA by assessment of time to deterioration in physical function TTDPF in participants with mCSPC(TTDPF is defined as the time from randomisation to deterioration in PROMIS Physical Function Short Form 8C scores.The analysis will include all randomised participants in the relevant subpopulation cohort as randomised. All events will be included, regardless of progression status.The measure of interest is the HR of TTDPF)
- To demonstrate the effectiveness of AZD5305 physicians choice NHA relative to placebo physicians choice NHA by assessment of health-related quality of life HrQoL using the BPI SF in participants with mCSPC(Change from baseline in BPI SF worst pain score, pain severity, and interference domain scores.)
- To evaluate tumour and blood samples collected from participants with mCSPC for mutations in BRCA and other HRR genes.(BRCA and other HRR gene mutation status.)
- To assess the PK of AZD5305 in plasma following single and multiple dosing, and explore the relationship between the PK concentration parameters and selected endpoints which may include pharmacodynamic parameters, efficacy, and or safety.(Plasma concentrations of AZD5305 parent and metabolites if applicable, and plasma PK parameters, including but not limited to AUC, Cmax, and Tmax, as data allow. Correlation of PK with other primary secondary exploratory endpoints in participants treated with AZD5305.)
- To demonstrate the effectiveness of AZD5305 physicians choice NHA relative to placebo physicians choice NHA by assessment of second progression free survival PFS2 in participants with mCSPC(Time from randomisation to PFS2 is defined as the time from randomisation to the earliest of progression defined as radiographic progression, clinical progression, or PSA progression after initiation of first subsequent treatment following the initial investigator assessed progression or death. The date of second progression will be recorded by the investigator in the eCRF and defined according to local standard clinical practice.)
- To demonstrate the effectiveness of AZD5305 physicians choice NHA relative to placebo physicians choice NHA by assessment of time to first subsequent therapy or death TFST in participants with mCSPC(TFST is defined as the time from randomisation to the start date of the first subsequent anticancer therapy after discontinuation of randomised treatment, or death due to any cause.The analysis will include all randomised participants in the relevant subpopulation/cohort as randomised. All events will be included, regardless of progression status.The measure of interest is the HR of TFST)
- To assess the safety and tolerability of AZD5305 physicians choice NHA as compared with placebo physicians choice NHA in participants with mCSPC(Safety endpoints will include, but are not limited to, the following:)
- To estimate the effectiveness of AZD5305 physicians choice NHA relative to placebo physicians choice NHA by assessment of objective response rate ORR in participants with mCSPC(ORR is defined as the proportion of participants with measurable soft tissue disease who have a CR or PR per RECIST 1.1 soft tissue and PCWG3 criteria bone, as determined by:)
- To estimate the effectiveness of AZD5305 physicians choice NHA relative to placebo physicians choice NHA by assessment of duration of response DoR in participants with mCSPC(DoR will be defined as the time from the date of first documented response until date of documented progression per RECIST 1.1 soft tissue and or PCWG3 criteria bone as assessed by the investigator or death due to any cause)
- To estimate the effectiveness of AZD5305 physicians choice NHA relative to placebo physicians choice NHA by assessment of PSA in participants with mCSPC(Time to PSA progression, defined as the time from randomisation to PSA progression per PCWG3 criteria.PSA50 PSA90 response: proportion of participants achieving a 50%/90% decrease in PSA from baseline. PSA undetectable rate at landmark timepoints eg, 6, 12 months proportion of participants with undetectable PSA 0.2 ng mL for those with PSA 0.2 ng mL at baseline.)
- To explore the efficacy of AZD5305 physicians choice NHA relative to placebo(physicians choice NHA in terms of prostate cancer specific mortality)
- To evaluate the effects of study intervention on ctDNA(May include but is not limited to assessment of changes from baseline in ctDNA and)
- To further evaluate predictive biomarkers of clinical benefit, mechanism of action and acquired resistance to AZD5305 in combination with an NHA which may be observed using:(Blood samples, tumour samples and ctDNA)
- To develop companion or complementary diagnostic(Collected samples (including derivatives) and data will be used to develop companion or complementary diagnostic for use with AZD5305)
- Future exploratory research into factors that may influence development of cancer and/or response to treatment, may be performed on the collected and stored archival tumour samples, blood samples and their derivatives(This may include:)
- To explore how genetic variations may affect clinical parameters, risk and prognosis of diseases and the response to medications. Note: the sample is taken from consented participants for DNA isolation and storage. Results will not be reported in the CSR(Exploratory endpoints are related to the data generated from the genetic analysis of part or all of the participant’s genetic information)
- To explore PSMA-PET imaging as a biomarker in participants with mCSPC(Investigation of changes in PSMA-PET parameters, including tumour SUVmax, SUVmean to determine endpoints including but not limited to:)
- To estimate the effectiveness of AZD5305 + physician’s choice NHA relative to placebo + physician’s choice NHA by assessment of patient-reported global impression of overall severity and treatment tolerability in participants with mCSPC(Proportion of participants reporting different levels of global impression of the severity of overall cancer symptoms and overall treatment tolerability as measured by PGI-S and the PGI-TT)
- To estimate the effectiveness of AZD5305 + physician’s choice NHA relative to placebo + physician’s choice NHA by assessment of patient-reported symptoms, treatment-related AEs, functioning and global health status (GHS) using the EORTC QLQ-QL2, EORTC QLQ-PR 25(US) (4 items), and 8 key items from the EORTC IL in participants with mCSPC(Change from baseline to post-baseline in key mCSPC symptoms and in GHS/quality of life (QoL) (EORTC QLQ QL2) as well as EORTC QLQ-PR 25(US) scores and 9 key items from EORTC IL.)
- To explore the impact of treatment and disease on health state in participants with mCSPC(Dimension response and visual analogue scale over time as captured by the EQ-5D-5L)
- To explore the impact of treatment and disease on health care resource use in participants with mCSPC(Number and type of hospitalisations and procedures, and length of stay, as captured by the Concomitant Procedure, SAE reporting forms and HOSPAD)
- To explore the use of a Computer Adaptive Testing (CAT) delivered measure of Physical Function in participants with mCSPC.(Comparison of compliance, reliability, and measurement error rates of a streamlined and tailored version of physical function, based on PROMIS PF CAT scores, to the corresponding PROMIS 8C values)
- (HRRm cohort))
- Assessment of overall survival (OS) in participants with mCSPC.
研究者
Mr Sandeep AV
AstraZeneca Pharma India Ltd
研究点 (12)
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