Studying Treatments in patients receiving androgen deprivation therapy (ADT) and androgen receptor signalling inhibitors (ARSI) for Metastatic Prostate Cancer: Evaluation of Drug and radiation Efficacy: A 2nd multi-arm multi-stage randomised controlled trial (STAMPEDE2).

niversity College London0 sites4,914 target enrollmentSeptember 22, 2023

Overview

No summary available.

Registry

who.int

Start Date

September 22, 2023

End Date

March 1, 2034

Last Updated

last year

Study Type

Interventional

Sex

Male

Sponsor

niversity College London

•General inclusion criteria
•1\. At least 18 years old
•2\. Histological confirmation of prostate adenocarcinoma on a biopsy of the prostate or metastases, or a strong clinical suspicion of prostate cancer with consent from the patient and a plan to undergo a confirmatory tissue biopsy.
•3\. Confirmation of metastatic site(s) on CT or bone scan. Patients with metastatic disease meeting the following criteria are eligible:
•Metastatic disease to the bone (in any distribution) visible on 99Tc\-Bone Scan
•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
•4\. De novo presentation or, if relapsed, all hormonal treatments (ADT and ARSI) will have been completed \=1 year prior to any future randomisation into any of the comparisons and have received \=1 year total of ADT. This will be checked again at randomisation.
•5\. If not already started, there must be intention to start long\-term androgen deprivation therapy (ADT).

•General exclusion criteria
•1\. Clinically and pathologically overt small cell carcinoma
•2\. Metastatic brain disease or leptomeningeal disease
•3\. 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)
•4\. Any other medical condition that in the investigator's opinion means the participant is unfit or unsuitable for long\-term ARSI or the trial treatments in the comparison for which they are being considered.
•Exclusion criteria For comparison S testing SABR
•1\. Prior radical treatment to the prostate (e.g., radical surgery and/or radiotherapy).
•2\. Intracranial metastatic disease
•3\. Prior treatment to a metastatic site (e.g., radiotherapy, surgery or RFA)
•4\. Significant or progressive neurological deficit such that emergency (within 24 hours) surgery or radiation required (e.g., metastatic spinal cord compression, or impingement of the cord or any other clinical scenario whereby urgent radiotherapy to the spine is required)