Stereotactic Prostate Radiotherapy With or Without Androgen Deprivation Therapy, a Phase III, Multi-institutional Randomized-controlled Trial. The SPA Trial.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- biochemical disease free survival
研究概览
简要总结
To clarify the role of short-term Androgen deprivation therapy (ADT) in the context of intermediate unfavorable and a subclass of high-risk patients treated with prostate Stereotactic radiotherapy (SRT).
In intermediate unfavorable risk group, when choosing standard external beam radiotherapy, short term ADT is superior in terms of biochemical disease free survival (bDFS) to EBRT alone. In high risk disease, results of the combination therapy are even more clear. Prostate SRT has been endorsed as option for primary radical treatment for prostate cancer. In such patients, the benefit of ADT is still unknown and the decision is left to clinical judgement.
For these reasons, it seems to be relevant to propose a randomized, open label, phase III clinical trial of prostate SBRT + 6 months ADT versus prostate SBRT alone in intermediate unfavorable and a subgroup of high risk prostate cancer patients.
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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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:
- •-Grade group 3 or/and
- •-2-3 risk factors for intermediate category (PSA 10-20 ng/ml/ Grade group 2-3/ cT2b cT2c) or/and
- •-biopsy cores positive ≥50%
- •Patients belonging to a subclass of high risk group according to the D'Amico/NCCN risk group classification:
- •-ISUP group 4 (GS 4+4, 3+5, 5+3) or
- •-cT3a stage or
- •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
- •Prostate Volume less than 100cc
- •PSA must be dosed maximum 60 days before randomization
- •No pathologic lymph nodes and distant metastasis on PET (fluorocholine) scan or CT scan+bone scan.
- •Contraceptive measures for patients with partners with reproductive potential must be explained
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.
- •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
- •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
研究组 & 干预措施
SRT+ADT
Patients in ARM A will be treated with SRT on the prostate (consecutive days or at alternate days to a total dose of 36.25 Gy administered in 5 fraction (7.25 Gy/fraction) + LHRH analogue (Triptoreline 22.5 mg). An anti-androgen drug (es. Bicalutamide 50 mg) must be administered daily starting from 7 days before LHRH analogue administration to 10 days after to prevent the flare effect
干预措施: Triptorelin Embonate (Drug)
SRT+ADT
Patients in ARM A will be treated with SRT on the prostate (consecutive days or at alternate days to a total dose of 36.25 Gy administered in 5 fraction (7.25 Gy/fraction) + LHRH analogue (Triptoreline 22.5 mg). An anti-androgen drug (es. Bicalutamide 50 mg) must be administered daily starting from 7 days before LHRH analogue administration to 10 days after to prevent the flare effect
干预措施: Bicalutamide 50 mg (Drug)
结局指标
主要结局
biochemical disease free survival
时间窗: outcome will be evaluated at the completion of 5 years of follow-up
form the date of the end of radiotherapy to the date of PSA meeting protocol criteria for biochemical relapse or last Follow-up visit. Outcome is mesured in months.
次要结局
- freedom from local recurrence(outcome will be evaluated at the completion of 5 years of follow-up)
- freedom from regional recurrence(outcome will be evaluated at the completion of 5 years of follow-up)
- Overall survival(outcome will be evaluated at the completion of 5 years of follow-up)
- quality of life, prostate related quality of life in prostate cancer(12 weeks after SRT, 3, 6 and 12 months after SRT)
- Disease free survival(outcome will be evaluated at the completion of 5 years of follow-up)
- quality of life, prostate related quality of life questionnarire(12 weeks after SRT, 3, 6 and 12 months after SRT)
- patients reported outcome, prostate related symptoms assessment(12 weeks after SRT, 3, 6 and 12 months after SRT)
- freedom from distant metastasis(outcome will be evaluated at the completion of 5 years of follow-up)
- patients reported outcome, erectile function assessment,(12 weeks after SRT, 3, 6 and 12 months after SRT)
- Clinician reported Acute Toxicity, assessed with CTCAE 5.0 scales(from the beginning of treatment until 6 months after SRT)
- Clinician reported Late Toxicity, assessed with CTCAE 5.0 scales(from 6 months after SRT 5 years of follow-up)
研究者
Marco Lorenzo Bonu
MD, Scientific coordinator
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia