Randomized control trial comparing ADT with abiraterone versus ADT with abiraterone and docetaxel in denovo metastatic hormone sensitive prostate cancer: A pilot study
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Radiological Progression-Free Survival (rPFS) demonstrated by PSMA PET CT scan
研究概览
简要总结
Eligible patients diagnosed with metastatic hormone-sensitive prostate cancer (mHSPC) meeting all inclusion and exclusion criteria will be approached for participation. Prior to enrollment, all participants will be thoroughly informed about the study objectives, procedures, potential risks and benefits using patient information sheet. Written informed consent will be obtained from each patient before any study-related procedures are initiated.A total of 50 patients with histologically confirmed metastatic hormone-sensitive prostate cancer (mHSPC) will be enrolled in the study. Patients will be randomly assigned in a 1:1 ratio to two treatment arms: Group A: ADT + Abiraterone (1000 mg/day) + Prednisolone (5 mg twice daily), Group B: ADT + Abiraterone (1000 mg/day) + Prednisolone (5 mg twice daily) + Docetaxel (75 mg/m² IV for 6 cycles).The process of randomization will begin once histopathology report of the primary TRUS guided biopsy is obtained. Randomization will be done using a computer-generated randomization schedule using block randomization technique. Sequentially numbered, opaque, sealed envelopes (SNOSE) will be used for allocation concealment. Both the treating surgeon and the patients will be aware of the management proposed. Patients will be block-randomized in a 1:1 ratio into two treatment arms: Group A: ADT + Abiraterone and Group B: ADT + Abiraterone + Docetaxel. Patients will be followed at regular intervals every 12 weeks for clinical assessment and laboratory monitoring, including PSA levels and adverse events. PSMA PET-CT will be repeated at 6 months and 12 months or earlier if biochemical or clinical progression is suspected. Patients will be followed for a minimum of 12 months or until disease progression, death, or withdrawal from the study.Systematic collection of data will be done using data collection sheet at baseline and at scheduled follow-up visits. This will include demographic details, clinical history and physical examination findings, laboratory values, imaging findings (including PSMA PET CT scans), treatment details, adverse events, PSA levels and progression, radiological assessments. All data will be anonymized and stored securely for analysis. After obtaining written informed consent, participants will undergo a series of basic investigations in accordance with institutional guidelines which are part of routine clinical practice. This will include complete blood count (CBC), renal function tests (serum creatinine and calculated creatinine clearance), liver function tests (bilirubin, AST, ALT, ALP), serum potassium levels, PSA levels, ECG and echocardiography for cardiac function (including ejection fraction), PSMA PET CT for staging and metastasis documentation, Ophthalmologic evaluation in patients with impaired vision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- Male
入选标准
- •Histologically confirmed adenocarcinoma of the prostate with no prior systemic treatment.
- •Evidence of metastatic disease on PSMA PET-CT or extra-pelvic nodal metastases (greater than 2 cm, or more than 1 cm with associated pelvic node more than 2 cm).
- •Age above 18 years, ECOG performance status 0 and 1, and life expectancy of more than 6 months.
- •Hematology values: Hemoglobin above 10.0, Platelet count more than 100,000, Neutrophil more than 1.5 lac.
- •Biochemical values: Renal function: serum creatinine less than 1.5 times the upper normal limit or a calculated creatinine clearance more than 60 mL/min, Serum potassium more than 4 mmol/L, Liver function: Serum bilirubin less than 1.5 x ULN (except for patients with documented Gilbert’s disease), AST and ALT less than 1.5 x ULN (and less than 5 times the upper normal limit in case of liver metastases), ALP less than 2.5XULN (in case of bone metastasis, ALK-P less than 1000U/L if bilirubin is normal)
- •Clinically fit and eligible to receive docetaxel per standard guidelines and drug labeling.
- •Signed informed consent after receiving full study information.
- •Willingness and ability to comply with treatment, follow-up, and study procedures.
排除标准
- •Prior chemotherapy or biological therapy for prostate cancer.
- •Chronic medical conditions requiring corticosteroids dosing more than 10 mg/day prednisone (or equivalent), or contraindications to corticosteroid use.
- •Active viral hepatitis, symptomatic liver disease, or history of pituitary/adrenal dysfunction (except Gilbert’s syndrome).
- •Uncontrolled hypertension (SBP more than 160 mmHg or DBP more than 95 mmHg despite treatment).
- •Clinically significant heart disease: recent MI, thrombotic events (within 6 months), unstable angina, NYHA Class II–IV heart failure, EF less than 50%, atrial fibrillation or arrhythmias requiring therapy.
- •Hypersensitivity to docetaxel, abiraterone, or related compounds.
- •Presence of cystoid macular oedema or significant ophthalmologic disease contraindicating docetaxel.
- •Concomitant use of strong CYP3A4 inhibitors (clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin).
结局指标
主要结局
Radiological Progression-Free Survival (rPFS) demonstrated by PSMA PET CT scan
时间窗: Follow up of 1 year after initiating therapy
次要结局
- 1. To compare PSA response between patients receiving ADT + Abiraterone and those receiving ADT + Abiraterone + Docetaxel.(2. To compare the time to PSA progression between the two groups)
研究者
Rahil Kumar
All India Institute of Medical Sciences