2024-517666-41-00招募中3 期
Short versus long-term androgen deprivation therapy combined with salvage radiotherapy in prostate cancer patients with biochemical recurrence after prostatectomy: a multicentre phase III randomised controlled trial
Instituto De Investigacion En Oncología Radioterapica FEOR17 个研究点 分布在 1 个国家目标入组 534 人开始时间: 2024年11月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 534
- 试验地点
- 17
- 主要终点
- Compared to short-term ADT (6 months), long-term ADT (24 months) could improve 5-year distant metastasis-free survival (MFS) in patients with biochemically-recurrent prostate cancer after radical prostatectomy who are candidates for salvage radiotherapy
研究概览
简要总结
To compare 5-year MFS rates in prostate cancer patients treated with long- versus short-term ADT in combination with salvage radiotherapy
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically-confirmed prostate cancer treated with radical prostatectomy. Patients who have not undergone lymph node dissection are eligible for inclusion
- •Biochemical recurrence after prostatectomy: BCR is defined as a PSA value ≥ 0.2 ng/mL, with at least one confirmatory PSA determination ≥ two weeks after the first test (the confirmatory PSA level must be higher than the initial value). Patients with Gleason 8-10, pT3b or R1 are eligible for inclusion in the trial with PSA ≥ 0.15 ng/mL; however, in patients with PSA > 0.4 ng/mL, imaging tests (conventional CT and bone scans or advanced imaging techniques such as PSMA or choline PET/CT) should be performed to check for metastases. In patients with PSA levels between 0.15 and 0.4 ng/mL, no further tests are required to check for distant metastases prior to inclusion.
- •Intermediate and high-risk patients according to the classification criteria proposed by González San Segundo et al. (18) (Protocol page 8)
- •Testosterone level > 150 ng/dL at inclusion
- •Life expectancy > 5 years
- •Signed informed consent
排除标准
- •Presence of pN1 disease in the original surgical specimen
- •Presence of macroscopic disease on imaging tests. If the PSA at diagnosis is > 0.4 ng/mL, then imaging tests (CT and bone scan and/or PET/CT or body magnetic resonance imaging [MRI]) are required
- •PSA <0.2 or <0.15 ng/mL (if Gleason score=10, pT3b, or R1 in the radical prostatectomy specimen).
- •Previous pelvic radiotherapy
- •Radiotherapy contraindicated
- •Ongoing treatment with ADT or PSA-modulating drugs (e.g., finasteride, dutasteride, high dose steroids)
- •Inability to understand the treatment protocol or sign informed consent
结局指标
主要结局
Compared to short-term ADT (6 months), long-term ADT (24 months) could improve 5-year distant metastasis-free survival (MFS) in patients with biochemically-recurrent prostate cancer after radical prostatectomy who are candidates for salvage radiotherapy
Compared to short-term ADT (6 months), long-term ADT (24 months) could improve 5-year distant metastasis-free survival (MFS) in patients with biochemically-recurrent prostate cancer after radical prostatectomy who are candidates for salvage radiotherapy
次要结局
未报告次要终点
研究者
Pablo Raña
Scientific
Instituto De Investigacion En Oncología Radioterapica FEOR
研究点 (17)
Loading locations...
相似试验
招募中
不适用
To determine whether androgen deprivation therapy or androgen blockage therapy upregulates receptor activity of Gallium68 Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) scans for men with castrate resistant prostate cancer.Metastatic Prostate CancerACTRN12617001116314St Vincent's Hospital, Sydney20
进行中（未招募）
1 期
The effect of androgen deprivation therapy on the expression of prostate specific membrane antigeMedDRA version: 20.0 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10071119 Term: Hormone-dependent prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Metastatic prostate cancerEUCTR2018-004853-26-FITurku University Hospital35
进行中（未招募）
1 期
The effect of androgen deprivation therapy on prostate specific membrane antigen (PSMA)Prostate cancerEUCTR2017-002345-29-FITurku University Hospital5
进行中（未招募）
4 期
The effect of intermittent versus continuous androgen deprivation therapy in Chinese patients with advanced prostate cancer: A prospective controlled Trial from ChinaCancer - Prostateprostate cancerACTRN12613000107729Changhai Hospital, Second Military Medical University100
招募中
不适用
atural Course of Hot Flash Symptoms in Men Receiving Androgen-Deprivation Therapy for Prostate Cancer – a Pilot Investigation.atural course of hot flashes in men with prostate cancer, receiving ADT for the first time.Natural course of hot flashes in men with prostate cancer, receiving ADT for the first time.Cancer - ProstateACTRN12613000566730A/Professor Henry Woo20