NCT05346848招募中2 期
A Randomized Non-comparative Phase II Multicentric Trial on Short Term Darolutamide (ODM-201) Concomitant to Radiation Therapy for Patients With Intermediate Unfavorable Risk Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 10
- 主要终点
- Assessment of efficacy in terms of 6-month biological response
研究概览
简要总结
Randomized non-comparative phase II trial to assess the preliminary signs of antitumor activity of darolutamide plus radiation therapy in patients with unfavorable intermediate risk prostate cancer.
详细描述
Multicentric randomized non-comparative, open-label, phase II trial, based on signle-stage design, to assess the preliminary signs of antitumor activity of darolutamide plus radiation therapy in patients with unfavorable intermediate risk prostate cancer.
Patients satisfying eligibility criteria will be randomized according to 2 treatment modalities
- Arm A (experimental arm): combination of external beam radiotherapy (EBRT) and 6 months darolutamide.
- Arm B (standard arm): combination of external beam radiotherapy (EBRT) and 6 months ADT (androgen deprivation therapy)
Two patients randomized in arm A for one patient randomized in arm B.
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
- •Histological diagnosis of prostate malignancy cancer
- •Cancer without loco-regional or distant metastasis (tumor assessment must comprise at least Pelvic MRI AND thoraco-abdomino-pelvic contrast-enhanced CT-Scan AND Bone Scintigraphy. (Note that additional assessment by PET-Scan is allowed as per investigator judgement),
- •Unfavorable intermediate risk prostate cancer diagnosis defined by the NCCN Guidelines.
- •One of the following criteria is sufficient to define an unfavorable intermediate risk prostate cancer:
- •Gleason = 7 (4+3)
- •≥ 50% of thecore of biopsies need to be positive for adenocarcinoma
- •If these criteria are not being identified, two or three of the following criteria are necessary to define unfavorable intermediate risk prostate cancer:
- •PSA value between 10-20 ng/ml
- •Gleason 7 (3+4) or 6
- •T2b (clinical or radiological) Note: patients with iT3a can be included only if gleason score is 6 and PSA less than 20 .
- •Patients newly diagnosed with an unfavorable intermediate risk prostate cancer according to the protocol criteria or previously diagnosed with low risk (Gleason score < 6, clinical stage < T2a, and PSA< 10) prostate cancer progressing to eligible risk disease according to the protocol criteria within 30 days before registration
- •Patients must have a life expectancy of at least 5 years,
- •Performance status ECOG ≤ 2,
- •Patients without contra-indications to EBRT as per physician judgement,
- •Patients with adequate organ function defined by all the following laboratory values
- •Available archived paraffin-embedded tumor sample for research purpose,
- •Patients with a social security in compliance with the french law,
- •Voluntary signed and dated written informed consent prior to any study specific procedure,
- •Men must agree to use an effective method of contraception throughout the treatment period and for one week after discontinuation of treatment.
排除标准
- •Stage T3b-T4 prostate cancer by clinical examination or radiologic evaluation,
- •Patients with Gleason score ≥8,
- •Patients with PSA >20 ng/ml,
- •Presence of loco-regional or distant metastasis,
- •Contra-indications to MRI and to contrast-enhanced CT-scan,
- •Hypogonadism or severe androgen deficiency as defined by screening serum testosterone less than 50 ng/dL or below the normal range for the institution.
- •Previous prostate cancer treated by androgen deprivation, chemotherapy, surgery, or radiotherapy,
- •Patients with previous orchiectomy
- •Patients actively receiving or having received within 6 months prior enrollment any concurrent androgens, anti-androgens, estrogens, or progestational agents,
- •Patients having received ketoconazole, finasteride or dutasteride within 30 days of inclusion,
- •Previous and current malignancies other than prostate cancer within the last 5 years with the exception of adequately treated basal cell or squamous cell carcinoma of the skin, acute lymphoblastic leukemia, non-muscle invasive bladder cancer,
- •Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection),
- •History of cerebrovascular accident (within the last 6 months)
- •Impaired cardiac function as defined in the Protocol
- •Uncontrolled hypertension
- •Impairment of gastrointestinal function or GI disease that may significantly alter the absorption of study drug,
- •Major surgery within 4 weeks prior enrolment except pelvic lymph-nodes dissection,
- •Known hypersensitivity to any involved study drug or of its formulation components, to natural gonadotrophin releasing hormone or its analogues
- •Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome
- •Men who are not using an effective method of contraception as previously described
- •Use of herbal or alternative remedies that may affect hormonal status such as Prostasol or PC-SPES,
- •History of non-compliance to medical regimens or inability to grant consent,
- •Patient unable to follow and comply with the study procedures because of any geographical, social or psychpsychological reasons,
- •Individuals under judicial protection or deprived of liberty.
- •Inability to swallow or to give subcutaneous or intramuscular injections.
研究组 & 干预措施
Experimental Arm A: combination of radiotherapy and darolutamide
Experimental
Patients with unfavorable intermediate risk prostate cancer will be treated with darolutamide for a maximum of 6 months combined with external beam radiotherapy
干预措施: Association of darolutamide and EBRT (Drug)
Standard Arm B: combination of radiotherapy and androgen deprivation therapy
Other
Patients with unfavorable intermediate risk prostate cancer will be treated with androgen deprivation therapy (ADT) as per market authorization combined with external beam radiotherapy
干预措施: Association of ADT and EBRT (Drug)
结局指标
主要结局
Assessment of efficacy in terms of 6-month biological response
时间窗: 6 months after randomization
Biological response is defined as a PSA concentration \<=0.1ng/mL according to Phoenix's criteria
次要结局
- Assessment of efficacy in terms of biological response at the end of darolutamide or ADT(An expected average of 6 months)
- 2-month biological response(2 months after randomization)
- 3-month biological response(3 months after the end of radiotherapy)
- 2-year biological response(2 years after randomization)
- 5-year biological response(5 years after randomization)
- 3-year biochemical progression-free survival (bPFS)(3 years)
- 6-month biological response(6 months after the end of radiotherapy)
- 9-month biological response(9 months after the end of radiotherapy)
- 3-year biological response(3 years after randomization)
- 2-year biochemical progression-free survival (bPFS)(2 years)
- 2-year metastasis free survival (MFS)(2 years)
- 5-year biochemical progression-free survival (bPFS)(5 years)
- 3-year metastasis free survival (MFS)(3 years)
- 5-year metastasis free survival (MFS)(5 years)
- 2-year disease free survival (DFS)(2 years)
- 3-year disease free survival (DFS)(3 years)
- 5-year disease free survival (DFS)(5 years)
- 2-year prostate cancer-specific survival (PCSS)(2 years)
- 3-year prostate cancer-specific survival (PCSS)(3 years)
- 5-year prostate cancer-specific survival (PCSS)(5 years)
- 2-year overall survival (OS)(2 years)
- 3-year overall survival (OS)(3 years)
- 5-year overall survival (OS)(5 years)
- Time to testosterone recovery(An expected average of 6 months)
- Acute safety profile independently for each treatment strategy(3 months)
- Late 2-year safety profile independently for each treatment strategy(2 years)
- Late 3-year safety profile independently for each treatment strategy(3 years)
- Assessment of quality of life(Throughout the follow-up period, an expected average of 5 years)
- Assessment of symptoms of benign prostatic hyperplasia(Throughout the follow-up period, an expected average of 5 years)
- Late 5-year safety profile independently for each treatment strategy(5 years)
- Assessment of erectile dysfunction(Throughout the follow-up period, an expected average of 5 years)
研究者
研究点 (10)
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