2025-522145-21-00招募中3 期
Studying Treatments in patients receiving androgen deprivation therapy (ADT) for Metastatic Prostate Cancer: Evaluation of Drug and radiation Efficacy: A 2nd multi-arm multi-stage randomised controlled trial (STAMPEDE2)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 9
- 主要终点
- For both Comparisons S and P, the primary outcome is Overall Survival (OS) defined as time from randomisation to death from any cause.
研究概览
简要总结
The primary objectives of each comparison are to test:
- Whether survival and/or cancer outcomes can be improved by the addition of the research treatments to SoC in men with metastatic prostate cancer and starting long-term androgen deprivation therapy.
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
- •I. At least 18 years old.
- •II. Histological confirmation of prostate adenocarcinoma or a strong clinical suspicion of prostate cancer with a plan to confirm the diagnosis formally before any future randomisation.
- •III. Confirmation of metastatic site(s) on CT/MRI and either bone or PET scan. Patients with metastatic disease meeting any of the following criteria are eligible: • Metastatic disease to the bone (in any distribution). • Non-regional lymph node metastases of any size or distribution. Lymph nodes that are only visible on PET will not be eligible as sites of metastasis. Note: If lymph nodes are the only site of metastases, then at least one must be at least 1.5cm in short axis AND outside of the pelvis. • Visceral metastases of any size or distribution.
- •IV. Clinical presentation is: A. de novo. OR B. relapsed with; (1) continuing hormone sensitivity in the opinion of the investigator, and; (2) all hormone treatments (e.g., ADT and ARPI) will have been completed ≥2 years prior to any future randomisation into any of the comparisons, and; (3) will have received ≤3 years total of ADT at the point of randomisation into any comparison. Note: the dates will be checked again at randomisation. It is the responsibility of the investigator to account for the time between registration and randomisation into any comparison.
- •V. Long-term androgen deprivation therapy (ADT) has started or there is an intention to start for a minimum of 2 years.
- •VI. WHO Performance Status 0-2 or, if WHO Performance Status 3, deemed to be due to metastatic burden and expected to improve with ADT. Note: Improvement to WHO status 0-2 will be checked again at randomisation into any subsequent comparison.
- •VII. Willing and able to comply with trial treatments.
- •VIII. Patient has signed informed consent form for registration into the STAMPEDE2 Trial platform.
- •Listed above are the general inclusion criteria into the STAMPEDE2 platform, comparison specific eligibility criteria are listed in section 4 of the Master Protocol
排除标准
- •I. Clinically and pathologically overt small cell carcinoma.
- •II. Metastatic brain disease or leptomeningeal disease.
- •III. Any active malignancies (i.e., progressing or requiring any treatment in the previous 36 months) other than prostate cancer (except non-muscle invasive bladder cancer; non-melanomatous skin cancer or a malignancy that is considered cured with minimal risk of recurrence).
- •IV. Any other medical condition that in the investigator's opinion means the participant is unfit or unsuitable for long-term ADT or the trial treatments in the comparison for which they are being considered.
- •Listed above are the general exclusion criteria into the STAMPEDE2 platform, comparison specific eligibility criteria are listed in section 4 of the Master Protocol
结局指标
主要结局
For both Comparisons S and P, the primary outcome is Overall Survival (OS) defined as time from randomisation to death from any cause.
For both Comparisons S and P, the primary outcome is Overall Survival (OS) defined as time from randomisation to death from any cause.
次要结局
- Failure-Free Survival (FFS), Radiographic Progression-Free-Survival (rPFS), Prostate cancer specific survival (PCSS), Safety, toxicity and compliance, Quality of life, Cost and resources.
研究者
Sponsor Trial Team
Scientific
University College London
研究点 (9)
Loading locations...
相似试验
招募中
2 期
Phase II Trial of PSA Response-based Androgen Deprivation Therapy and Nodal Coverage for Prostate Cancer Early Salvage Radiotherapy (RANGER)Prostate CancerNCT07313241University of Texas Southwestern Medical Center68
尚未招募
2 期
Darolutamide+ADT Post-RP w/o ePLND in hrPC: Briganti 2019Prostate CancerNCT07282197Peking University First Hospital40
尚未招募
2 期
Use of Topical Testosterone and Estrogen vs Estrogen Alone in Vulvodynia: a Randomized Controlled TrialDyspareuniaNCT07260825TriHealth Inc.44
进行中（未招募）
2 期
A Study of BMS986365 in Combination With Degarelix in People With Prostate CancerProstate CancerNCT07335796Memorial Sloan Kettering Cancer Center7
已完成
不适用
Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer CHAARTED-C61 Malignant neoplasm of prostateMalignant neoplasm of prostateC61PER-081-08EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG),