2023-509837-37-00招募中2 期
A feasibility trial investigating inductive Apalutamide therapy combined with radical prostatectomy in patients with locally advanced T4 high risk prostate cancer
Universitaet Des Saarlandes2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年1月18日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- The prim endpoint of this study is the proportion of pat. with operability - as assessed by MRI , transrectal ultrasound, and clinical examination (two experienced uro oncological surgeons) - upon inductive pre-prostatectomy treatment for a duration of up to 6 months. For patients who have not reached the PSA nadir after the 6-month period and are not considered as operable, the inductive therapy with apalutamide plus ADT can be expanded for a maximum of additiona
研究概览
简要总结
The primary objective of this study is to assess operability in patients with locally advanced T4 high risk prostate cancer upon inductive preprostatectomy treatment with apalutamide plus ADT for a duration of up to 6 months.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male of 18 to 80 years of age, inclusive
- •Must agree to wear a condom when engaging in any activity that allows for passage of ejaculate to another person while on study drug and for 3 months following the last dose of study drug
- •Must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 90 days after receiving the last dose of IMP
- •Must sign an ICF indicating that he understands the purpose of and procedures required for the study and is willing to participate in the study.
- •Histologically confirmed adenocarcinoma of the prostate without complete neuroendocrine differentiation or small cell features
- •cT4 PCa, considered as primary inoperable because of a fixed mass defined by digital rectal examination, confirmed by advanced disease in MRI
- •Eastern Cooperative Oncology Group Performance Status 0 or 1, patients must and are expected to be fit and willing to undergo radical prostatectomy within 6 to 9 months after start of study treatment
- •Adequate organ function determined by the following laboratory values: a.Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and total bilirubin less than twice the upper limit of normal b.Platelets ≥100,000/L, independent of transfusion and/or growth factors within 1 month prior to enrolment
- •At least 4 weeks must have elapsed from the use of 5-alpha reductase inhibitors and estrogens prior to enrolment
- •No irradiation of the pelvis
- •Be able to swallow whole study drug tablets
- •Not candidate for radiotherapy or who deny radiotherapy
排除标准
- •Presence of distant metastasis (clinical stage M1) after MRI, CT abdomen and bone scan Note: Patients with distant metastases only detectable in PSMA-PET/CTs are allowed to be included in the trial when conventional imaging (CT and bone scan) is negative for distant metastases
- •History of any pelvic radiation
- •Bilateral orchiectomy
- •History or evidence of any of the following conditions: any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years prior to enrolment; severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events, or clinically significant ventricular arrhythmias within 6 months; uncontrolled hypertension; history of seizure or convulsion; gastrointestinal disorder affecting absorption; active infection; and, any other condition that, in the opinion of the investigator, would impair the patient's ability to comply with study procedures
- •Presence of any of the following cardiologic criteria: a) Mean resting QTc >470 msec b) In patients with a history of risk factors for QT prolongation and in patients receiving concomitant medicinal products that might prolong the QT interval, the benefit-risk ratio including the potential for Torsade de pointes will be carefully assessed and patients will be excluded if the benefit-risk ratio is considered as unfavorable.
- •Active or symptomatic viral hepatitis or chronic liver disease; ascites or bleeding disorders secondary to hepatic dysfunction
- •Any active infection requiring systemic therapy
- •Known or suspected contraindications or hypersensitivity to apalutamide, or GnRH agonists or any of the components of the formulations
- •Patient is eligible for PROTEUS study (all patients with operable, non T4 disease)
- •Patient has received another investigational medication (including investigational vaccines) or used another invasive investigational medical device within 30 days before the planned first dose of the IMP of this study or is currently enrolled in another investigational study.
- •Pathological finding consistent with small cell, ductal, or complete neuroendocrine prostate cancer
- •Prior treatment with second generation anti-androgens
- •Prior treatment with CYP17 inhibitors
- •Prior treatment with systemic glucocorticoids ≤4 weeks prior to enrolment or patient expected to require long-term use of corticosteroids during the study
- •Use of 5-α reductase inhibitors (eg, dutasteride, finasteride) ≤4 weeks prior to enrolment
- •Major surgery ≤4 weeks prior to enrolment
- •Prior treatment with radiopharmaceutical agents
- •Prior chemotherapy for prostate cancer
结局指标
主要结局
The prim endpoint of this study is the proportion of pat. with operability - as assessed by MRI , transrectal ultrasound, and clinical examination (two experienced uro oncological surgeons) - upon inductive pre-prostatectomy treatment for a duration of up to 6 months. For patients who have not reached the PSA nadir after the 6-month period and are not considered as operable, the inductive therapy with apalutamide plus ADT can be expanded for a maximum of additiona
The prim endpoint of this study is the proportion of pat. with operability - as assessed by MRI , transrectal ultrasound, and clinical examination (two experienced uro oncological surgeons) - upon inductive pre-prostatectomy treatment for a duration of up to 6 months. For patients who have not reached the PSA nadir after the 6-month period and are not considered as operable, the inductive therapy with apalutamide plus ADT can be expanded for a maximum of additiona
次要结局
- Proportion of patients with pT0 (pCR) in prostatectomy specimens (complete pathological response)
- Proportion of patients with negative margin specimen from prostatectomy according to the histology results after surgery
- Proportion of patients with
- Proportion of patients with post-prostatectomy complete biochemical remission (non-detectable serum PSA) 6 months after surgery without hormonal treatment
- Proportion of patients with post-prostatectomy complications requiring surgical re-intervention (Clavien-Dindo IIIB complications, except for interventions aiming at hemostasis only) during the entire postprostatectomy period
- Proportion of patients who achieve PSA nadir upon 6 months of inductive treatment
- Proportion of patients who achieve PSA nadir, prior to surgery
- Change from baseline in FACT-P scores (FACT-P Trial Outcome Index, FACT-G total score, and FACT-P total score) at different study visits.
- Proportion of patients with improvement in their FACT-P scores compared to baseline at different study visits.
- Change from baseline in EQ-5D-3L score at different study visits.
- Proportion of patients with improvement in the EQ-5D-3L score compared to baseline at different study visits.
- Proportion of patients with early (ie, before prostatectomy) PSA relapse from nadir, defined as an absolute PSA increase of more than 10% from the initial PSA value prior to therapy with two PSA rises after 2 consecutive measurements within 2 weeks.
- Proportion of patients with biochemical recurrence (BCR), defined as 2 consecutive PSA values >0.2 ng/mL and rising obtained at two consecutive scheduled study visits after prostatectomy.
- Time to biochemical recurrence (BCR) after prostatectomy, if possible.
- The change in ECOG performance status as well as the change in some hematologic parameters (hemoglobin, leukocytes, lymphocytes, neutrophils, platelets), and the change in levels of serum testosterone/hormones from baseline at different study visits
- Time to treatment discontinuation.
- Safety and tolerability with regard to adverse events (AEs), abnormal laboratory results, and perioperative complications.
研究者
Prof. Stöckle
Scientific
Universitaet Des Saarlandes
研究点 (2)
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