Prostate cancer CRO

Accelerate your treatment to market with an experienced, patient-centered prostate cancer CRO

Prostate cancer affects more men than any other cancer. At Parexel, we have the expertise, relationships, and approaches you’ll need to navigate its unique clinical challenges — so your treatment can impact patients around the world.

As your prostate cancer CRO, we provide integrated support across all phases of clinical development. Our expertise includes interventional trials, biomarker studies, radiopharmaceutical trials, combination therapy studies, observational/registry studies, and quality of life and patient-reported outcome studies. Our experience also covers a wide range of prostate cancers, including:

  • Localized prostate cancer
  • Biochemically recurrent prostate cancer
  • Metastatic hormone-sensitive prostate cancer (mHSPC)
  • Castration-resistant prostate cancer (CRPC)
  • Metastatic castration-resistant prostate cancer (mCRPC)
     

Experience in the past 5 years in prostate cancer

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clinical projects
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patients
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sites

Advantages

Proven expertise in oncology

Our dedicated oncology team has an extensive track record supporting successful prostate cancer trials across all phases and treatment modalities. Their deep understanding of prostate cancer biology, the treatment landscape, and evolving standards of care equip them well to guide your study to success.
 


Advanced patient recruitment & retention

Competition with other prostate cancer trials is always a challenge for patient recruitment and retention. As your prostate cancer CRO, we help achieve and exceed your goals by delivering high-performing sites with proven prostate cancer recruitment capabilities, strategies to reduce patient burden, and strong site relationships that include key opinion leaders and investigators in prostate cancer research.
 


Expertise in patient-reported outcomes

With many prostate cancer patients being over the age 65, patient-reported outcomes are a key part of developing treatments that truly meet their needs. We have extensive expertise capturing these insights, with electronic collection improving compliance and data quality and regulatory support ensuring PRO endpoints meet regulatory requirements for labeling claims.
 


Global regulatory strategy and support

Our team of 1,000+ global regulatory experts has experience with authorities around the world, allowing us to navigate complex and evolving requirements across regions. We also have deep experience with breakthrough therapy, fast track, and other expedited programs to help accelerate your study. By considering payer requirements early, we also lay the groundwork for more successful market access.
 


Advanced biomarker & imaging capabilities

Grounded in our experience as an oncology CRO, we have expertise in incorporating novel biomarkers for patient stratification and response assessment beyond just PSA tests. We also have specialized knowledge in bone scan interpretation, advanced imaging techniques for metastatic disease, and standardized assessment for radiographic endpoints to reduce variability.
 


Innovative study designs

We maximize opportunities in your study through innovative designs. That means incorporating the flexibility to modify trials based on emerging data, implementing platform trials to efficiently test multiple treatments or combinations, and complementing traditional trials with real-world data to support regulatory submissions.

CASE STUDY

Accelerating enrollment for an mCRPC study

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Situation

We conducted a Phase II study for metastatic castrate-resistant prostate cancer (mCRPC) that took place in a highly competitive trial environment. The trial, which included 100+ patients in 50+ sites, involved a complex crossover design.

Solution

  • Full-service approach to meet all the study’s needs
  • Procedural documents from our medical monitor
  • Strategic site selection and study planning to create realistic enrollment expectations
  • Established relationships with known sites and key opinion leaders in mCRPC to help accelerate the project
     

Outcome

The study was a success, with enrollment completed a full two months ahead of target.