NCT01957436进行中（未招募）3 期
A Prospective Randomised Phase III Study Of Androgen Deprivation Therapy With Or Without Docetaxel With Or Without Local Radiotherapy With Or Without Abiraterone Acetate And Prednisone In Patients With Metastatic Hormone-Naïve Prostate Cancer
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- UNICANCER
- 入组人数
- 1,173
- 试验地点
- 77
- 主要终点
- Survival
研究概览
简要总结
This is a multi-center phase III study to compare the clinical benefit of androgen deprivation therapy with or without docetaxel with or without local radiotherapy with or without abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer.
详细描述
Eligible patients can be randomize in the trial after his consent form has been signed, and after all inclusion and non-inclusion criteria have been checked.
The randomisation will result in the allocation of arm A (ADT +docetaxel), arm B (ADT +docetaxel +Abiraterone), arm C (ADT +docetaxel +radiotherapy) or arm D (ADT +docetaxel +Abiraterone +radiotherapy) in a 1:1:1:1 ratio.
The randomization will be stratified (by minimization) according to:
- enrolment center,
- performance status (0 vs. 1-2)
- disease extent: lymph nodes only vs. bone (with or without lymph nodes) vs. presence of visceral metastases.
CRPC is defined by cancer progression (either a confirmed PSA rise or a radiological progression) with serum testosterone being at castrated levels (<0.50 ng/mL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Patients with previous definitive local treatment directed to the prostate primary cancer (radiotherapy, brachytherapy, radical prostatectomy, ultrasound, cryotherapy, or other). A previous trans-urethral resection of the prostate (TURP) and previous local treatments of metastases are allowed,
- •Prior cytotoxic chemotherapy or biological therapy for the treatment of prostate cancer,
- •Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone/prednisolone twice daily,
- •Active infection or other medical condition for which prednisone/prednisolone (corticosteroid) use would be contra-indicated,
- •Previously treated with ketoconazole for prostate cancer for more than 7 days,
- •Prior systemic treatment with an azole drug (e.g. fluconazole, itraconazole) within 4 weeks of randomization,
- •Hypertension not controlled by an anti-hypertensive treatment (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg; 3 consecutive measures taken 5 minutes apart),
- •Severe or moderate hepatic impairment (Child - Pugh class C or B)
- •Active or symptomatic viral hepatitis or chronic liver disease (except Gilbert's disease),
- •History of pituitary or adrenal dysfunction,
- •Clinically known significant heart disease in the past 6 months as evidenced by myocardial infarction, or arterial thrombotic events, severe or unstable angina, or New York Heart association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of < 50% at baseline,
- •Atrial Fibrillation, or other cardiac arrhythmia requiring therapy,
- •Patient with unstable pulmonary disease (eg. Pulmonary embolism)
- •Pathological finding consistent with small cell carcinoma of the prostate,
- •History of malignancy, except non-melanoma skin cancer, with a ≥ 30% probability of recurrence within 24 months,
- •Known allergies, hypersensitivity or intolerance to the study drugs or excipients or docetaxel
- •Administration of an investigational therapeutic within 30 days of randomization,
- •Patients already included in another therapeutic trial involving an experimental drug (patient in a non-experimental trial with no modification of the patient's care can be included),
- •Patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule or any condition which, in the opinion of the investigator, would preclude participation in this trial. Those conditions should be discussed with the patient before registration in the trial,
- •Individual deprived of liberty or placed under the authority of a tutor.
- •Patients with impaired vision should undergo a prompt and complete ophthalmologic examination.
- •Patients with Cystoid Macular Oedema cannot be included due to a potential risk of deterioration associated with docetaxel.
- •Concomitant use of strong CYP3A4 inhibitors (clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin.)
研究组 & 干预措施
Arm A
Active Comparator
androgen deprivation therapy + docetaxel
干预措施: Androgen Deprivation Therapy (Other)
Arm A
Active Comparator
androgen deprivation therapy + docetaxel
干预措施: Docetaxel (Drug)
Arm B
Experimental
androgen deprivation therapy + docetaxel + abiraterone acetate + prednisone
干预措施: abiraterone acetate (Drug)
Arm B
Experimental
androgen deprivation therapy + docetaxel + abiraterone acetate + prednisone
干预措施: Androgen Deprivation Therapy (Other)
Arm B
Experimental
androgen deprivation therapy + docetaxel + abiraterone acetate + prednisone
干预措施: Docetaxel (Drug)
Arm C
Experimental
Arm A + radiotherapy
干预措施: radiotherapy (Radiation)
Arm C
Experimental
Arm A + radiotherapy
干预措施: Androgen Deprivation Therapy (Other)
Arm C
Experimental
Arm A + radiotherapy
干预措施: Docetaxel (Drug)
Arm D
Experimental
Arm B + radiotherapy
干预措施: abiraterone acetate (Drug)
Arm D
Experimental
Arm B + radiotherapy
干预措施: radiotherapy (Radiation)
Arm D
Experimental
Arm B + radiotherapy
干预措施: Androgen Deprivation Therapy (Other)
Arm D
Experimental
Arm B + radiotherapy
干预措施: Docetaxel (Drug)
结局指标
主要结局
Survival
时间窗: 9.5 years after the first inclusion
Overall and radiographic progression-free survival in hormone-naïve prostate cancer patients with low metastatic burden whatever the standard of care received
次要结局
- PSA response rate(9.5 years after the first inclusion)
- Time to chemotherapy for CRPC(9.5 years after the first inclusion)
- Castration resistance-free survival (CRFS)(9.5 years after the first inclusion)
- Serious Genitourinary event-free survival (S-GU-EFS)(9.5 years after the first inclusion)
- Prostate cancer specific survival(9.5 years after the first inclusion)
- Quality of life questionnaire - Core 30 (QLQ-C30)(At baseline, 6 months, 18 months, and at the end of treatment (up to 9.5 years))
- Toxicity (with a specific focus on the use of long-term low-dose steroids)(Throughout study completion, up to 9.5 years)
- Time to next skeletal-related event(9.5 years after the first inclusion)
- Time to pain progression(9.5 years after the first inclusion)
- Correlation of biomarkers with outcome(9.5 years after the first inclusion)
- Prospective correlative study of PSA response/progression at 8 months after initation of ADT(9.5 years after the first inclusion)
- Changes in bone mineral density(At baseline, 6 months, 12 months, and 24 months)
- Functional Assessment of Cancer Therapy - Prostate (FACT-P)(At baseline, 6 months, 12 months, 18 months, and at the end of treatment (up to 9.5 years))
研究者
研究点 (77)
Loading locations...
相似试验
终止
3 期
A Study of Androgen Deprivation With Leuprolide, +/- Docetaxel for Clinically Asymptomatic Prostate Cancer Participants With a Rising Prostate Specific Antigen (PSA)Prostatic NeoplasmsNCT00514917Sanofi413
进行中（未招募）
3 期
A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPCMetastatic Castrate-sensitive Prostate CancerNCT05884398Janssen Research & Development, LLC420
终止
3 期
A Trial of SHR3680 in Prostate Cancer Patients Who Are Candidates for Radical ProstatectomyPatients With High-risk Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical ProstatectomyNCT05009290Jiangsu HengRui Medicine Co., Ltd.391
已完成
3 期
A Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate CancerProstate CancerNCT03009981Alliance Foundation Trials, LLC.504
进行中（未招募）
3 期
Study on the Role of Hormonal Treatment for Two Dosage Levels of Prostate Radiation Therapy Versus Prostate Radiation Therapy AloneProstate CancerNCT00223145Abdenour Nabid600
相关资讯
Darolutamide Gains FDA Approval for Metastatic Hormone-Sensitive Prostate Cancer Following ARANOTE Trial Success- Darolutamide (Nubeqa) received FDA approval on June 3, 2025, for treating metastatic hormone-sensitive prostate cancer based on the ARANOTE trial results.
- The ARANOTE trial demonstrated efficacy of darolutamide plus androgen deprivation therapy as a doublet regimen, expanding treatment options beyond existing triplet therapies.
- NCCN guidelines now include four Category 1 preferred oral agents for mHSPC: abiraterone, apalutamide, enzalutamide, with darolutamide expected to be upgraded from Category 2B status.
- The approval provides patients with low-volume metachronous disease an additional oral treatment option that minimizes adverse events while maintaining aggressive therapeutic approach.last yearmCSPC Prognosis Linked to AR, Neuroendocrine Markers, and Tumor Suppressor Gene Alterations- Analysis of the PEACE-1 trial reveals that AR and neuroendocrine marker expression can identify patient subgroups in metastatic castration-sensitive prostate cancer (mCSPC) with varying outcomes.
- Patients with AR-high luminal tumors showed better prognoses, while those with neuroendocrine prostate cancer exhibited worse outcomes, particularly driven by neuroendocrine marker expression.
- Alterations in TP53, PTEN, and RB1 tumor suppressor genes were prognostically significant, with patients having fewer than two alterations showing improved overall survival.
- Neither AR nor neuroendocrine biomarkers predicted response to abiraterone acetate plus prednisone, leaving the need for predictive biomarkers for abiraterone benefit in mCSPC undetermined.last yearTriplet Therapy vs. Doublet Therapy in Metastatic Prostate Cancer: A Treatment Debate- Triplet therapy, combining ADT, ARPIs, and docetaxel, is considered the most effective first-line treatment for metastatic hormone-sensitive prostate cancer (mHSPC) due to its multi-targeted approach.
- The PEACE-1 and ARASENS trials demonstrated that triplet therapy significantly improves overall survival (OS) and progression-free survival (PFS) compared to doublet therapy in mHSPC patients.
- Doublet therapy, such as ADT plus ARPIs, still holds a role in mHSPC treatment, especially considering the heterogeneity of prostate cancer and varying patient risk profiles.
- Ongoing debate centers on tailoring treatment approaches based on disease volume and risk, with a need for trials evaluating chemotherapy plus APRI and ADT versus placebo plus APRI and ADT.last year