STAMPEDE2: A randomised controlled platform trial testing treatments in metastatic hormone sensitive prostate cancer

Prior treatment

• 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).

Other illness

• Metastatic brain disease or leptomeningeal disease.
• 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

Other

• Clinically and pathologically overt small cell carcinoma.

• At least 18 years old.
• 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.
• 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.
• 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.
• Long-term androgen deprivation therapy (ADT) has started or there is an intention to start for a minimum of 2 years.
• 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.
• Willing and able to comply with trial treatments.
• 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