Improving Prostate Cancer Outcomes through Innovative Imaging in Clinical Trials
Prostate cancer is the most common cancer among men and the second leading cause of cancer death after lung cancer. Advances in imaging techniques, particularly multiparametric magnetic resonance imaging (mpMRI) and prostate-specific membrane antigen (PSMA) PET/CT (that Imaging Endpoints helped bring to market), have significantly improved diagnosis and staging of the disease. While these innovations enhance clinical trials and biomarker identification, challenges remain in ensuring their standardization and effective implementation.
Prostate cancer, traditionally considered a “cold tumor” due to its immunosuppressive microenvironment and genetic expression, has seen substantial changes in management with the advent of novel treatments that improve survival rates. Besides being one of the most diagnosed cancers worldwide, its incidence increases significantly with age, affecting around 59% of men over 79. Transrectal prostate biopsy is mainly used for diagnosis globally for a raised prostate specific antigen (PSA) value, but CT / MRI is still used for most patients along with 99mTc Bone Scan for their easy accessibility and relatively low cost.
CT scans and MRIs are essential in the initial staging for identifying local, regional and metastatic spread of prostate cancer. Among these, mpMRI, which integrates T2-weighted imaging, diffusion-weighted imaging, and dynamic contrast-enhanced sequences, demonstrates significantly greater sensitivity for prostate cancer detection compared to TRUS-guided biopsy (93% vs. 48%). It effectively rules out clinically significant cancers, thereby reducing the need for unnecessary repeat biopsies. In clinical trials, the use of PCWG3 criteria, when combined with RECIST 1.1 criteria, is critical for evaluation of prostate cancer in clinical trials as these criteria provide a comprehensive assessment of treatment response and disease progression.
Recent studies suggest that metastasis-free survival can be a valid surrogate for overall survival in localized advanced prostate cancer. The integration of PSMA-PET further improves the evaluation of treatment responses and is likely to be included in the new PCWG4 criteria that is expected to be published soon. Additionally, ongoing clinical trials are exploring PSMA-targeted radiation therapies and novel hormone treatments for castrate-resistant prostate cancer, ultimately aiming to improve patient outcomes.
Imaging Endpoints (IE) is the global leader in designing the imaging requirements for clinical trial protocols in prostate cancer, with numerous recent regulatory approvals. IE leads the way by collaborating with scientists, investigators, and radiologists to implement clarifications and/or modifications to the imaging criteria by integrating cutting-edge modalities and important criteria changes that are essential for each unique trial’s requirements.
Through a perfect inspection record and industry-leading marketing authorization success rate, our experts are dedicated to improving your clinical trial outcomes. To connect with our experienced medical and scientific team that specializes in optimizing imaging charter and explore how our tailored imaging solutions can support your Prostate Cancer clinical trials.
