STAMPEDE (clinical trial)

A large clinical trial investigating treatments for prostate cancer

STAMPEDE (clinical trial)

Prostate cancer cells

The STAMPEDE trial (Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy) is a large, multi-arm, multi-stage clinical trial designed to evaluate the effectiveness of various treatments for prostate cancer. It is one of the largest randomized controlled trials in prostate cancer, aiming to improve outcomes for men with high-risk, locally advanced, or metastatic prostate cancer.

Background

Prostate cancer is one of the most common cancers affecting men worldwide. Traditional treatments have included surgery, radiotherapy, and hormone therapy. However, the optimal combination and sequence of these treatments, especially in advanced stages, have been subjects of ongoing research. The STAMPEDE trial was initiated to address these questions by testing new treatment strategies and combinations.

Design

The STAMPEDE trial uses a multi-arm, multi-stage (MAMS) design, which allows for the simultaneous testing of several treatment strategies against a common control group. This innovative design enables the trial to adapt over time, adding new treatment arms as promising therapies emerge and dropping ineffective ones. This approach increases the efficiency of the trial and accelerates the evaluation of new treatments.

Treatment Arms

The trial has included various treatment arms over time, testing combinations of standard hormone therapy with additional treatments such as:

• Docetaxel, a chemotherapy drug
• Abiraterone, a drug that blocks androgen production
• Enzalutamide, an androgen receptor inhibitor
• Radiotherapy to the prostate in men with metastatic disease

Each arm is compared to the standard of care, which typically involves androgen deprivation therapy (ADT).

Outcomes

The primary outcome measure for the STAMPEDE trial is overall survival, with secondary outcomes including progression-free survival, quality of life, and cost-effectiveness. The trial has provided significant insights into the management of advanced prostate cancer, influencing clinical guidelines and practice.

Impact

Results from the STAMPEDE trial have led to changes in the standard treatment for advanced prostate cancer. For example, the addition of docetaxel or abiraterone to standard hormone therapy has been shown to improve survival in men with newly diagnosed metastatic prostate cancer. These findings have been incorporated into treatment guidelines worldwide.

Future Directions

The STAMPEDE trial continues to evolve, with new treatment arms being added to explore emerging therapies and combinations. The trial's adaptive design allows it to remain at the forefront of prostate cancer research, providing ongoing contributions to the understanding and treatment of the disease.

Related pages

• Prostate cancer
• Clinical trial
• Hormone therapy (oncology)
• Chemotherapy