2024-520093-34-00招募中3 期
Stereotactic body radiation therapy on Prostate with or without Androgen deprivation therapy, a phase III randomized controlled trial (SPA Trial)
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia23 个研究点 分布在 1 个国家目标入组 310 人开始时间: 2025年1月31日最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 310
- 试验地点
- 23
- 主要终点
- • To determinate if there is improvement in biochemical Disease free survival (bDFS, defined as PSA elevation ≥ 2 ng/ml over Nadir, following the Phoenix criteria*) in patients treated with prostate SBRT + ADT (ARM A) compared to patients treated with SBRT alone (ARM B).
研究概览
简要总结
To determinate if there is improvement in biochemical Disease Free Survival (bDFS) in patients treated with SBRT+ADT versus SBRT alone.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years old.
- •Prostate Volume less than 100cc
- •PSA must be dosed maximum 60 days before randomization
- •No pathologic lymph nodes and distant metastasis on PET scan (fluorocholine or fluoroPSMA- galliumPSMA ) or CT scan+bone scan.
- •Histological confirmation of prostate acinar adenocarcinoma with a minimum of 10 biopsy cores taken
- •Prostate protocol MRI for local staging
- •Patients belonging to intermediate unfavorable group according to the D’Amico/NCCN risk group classification: o -Grade group 3 or/and o -2-3 risk factors for intermediate category (PSA 10-20 ng/ml/ Grade group 2-3/ cT2b-cT2c) or/and o -biopsy cores positive ≥50%
- •Patients belonging to a subclass of high risk group according to the D’Amico/NCCN risk group classification: o -ISUP group 4 (GS 4+4, excluding 3+5 and 5+3) or o -cT3a stage or o PSA>20 ng/ml
- •Eastern Coooperative Oncology Group (ECOG) PS 0-2
- •Ability of the patient to understand and sign a written informed consent document
- •Ability and Willingness to comply with patients reported outcome questionnaires schedule during the study time
- •IPSS 0-15
排除标准
- •History of Malignant tumors in the previous 2 years excluding non melanoma cancers of the skin. If a patient presents an anamnesis of malignancy (excluding non melanoma skin cancers) it must be free from disease since 24 months at the time of enrollement. Patients affected by hematologic tumors in clinical-radiologic remission since at least 5 years after treatment or after follow-up only for which the prognosis is more than 10 years could be included in the trial after heamtologic consultation clearly declaring the prognosis. (chronic leucemia, phollicolar lymphoma, myelodisplastic syndromes).
- •Controindication or hypersensitivity to the use of Triptoreline
- •5alpha reductase inhibitors not discontinued 4 weeks prior to randomization
- •History of bone fractures and fall
- •Risk factors for abnormal heart rhythms or QT prolongation.
- •Use of concomitant medications that prolong the QT/QTc interval
- •Previous prostate surgery other than TURP (at least 6 weeks prior to start of SBRT).
- •Previous pelvic RT
- •Prior androgen deprivation therapy (excluding 5alpha reductase inhibitors)
- •Any prior active treatment for prostate cancer; patients on previous active surveillance are eligible if inclusion criteria are met
- •Active severe inflammatory bowel disease
- •Bilateral hip prothesis or any implant that could seriously interfere with dosimetric calculations
- •Age >80 years.
- •cT4a, cT3b or pelvic lymph node involvement
结局指标
主要结局
• To determinate if there is improvement in biochemical Disease free survival (bDFS, defined as PSA elevation ≥ 2 ng/ml over Nadir, following the Phoenix criteria*) in patients treated with prostate SBRT + ADT (ARM A) compared to patients treated with SBRT alone (ARM B).
• To determinate if there is improvement in biochemical Disease free survival (bDFS, defined as PSA elevation ≥ 2 ng/ml over Nadir, following the Phoenix criteria*) in patients treated with prostate SBRT + ADT (ARM A) compared to patients treated with SBRT alone (ARM B).
次要结局
- • Freedom from distant metastasis (FFDM, defined as evidence of out of field recurrence that meets the criteria of M1 defined by TNM VIII)
- • Disease free survival (DFS, defined as evidence of biochemical, local, regional or distant relapse on imaging).
- • Freedom from local recurrence (FFLR, defined as evidence of in-field recurrence detected at imaging and/or Histologically proved)
- • Freedom from regional recurrence (FFRR, defined as evidence of out-of field recurrence in the true pelvis as defined by TNM VIII criteria for regional node)
- • Overall Survival (OS, defined as death for any cause)
研究者
SC Clinical Trial Center - Dr. Aldo Maria Roccaro
Scientific
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
研究点 (23)
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