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GU Cancers 2026 | Trial design recommendations for prostate cancer: PCWG4 guidance

Andrew Armstrong, MD, MS, Duke Cancer Institute, Durham, NC, discusses updated recommendations from the Prostate Cancer Clinical Trials Working Group 4 (PCWG4) for clinical trial design in advanced prostate cancer. The guidance addresses evolving imaging modalities, particularly positron emission tomography-defined disease, molecular phenotyping, and genetic subtyping. New terminology and eligibility criteria are proposed, along with imaging-specific response assessment criteria including prostate-specific membrane antigen positron emission tomography/computed tomography guidance. This interview took place at the 2026 ASCO GU Cancers Symposium in San Francisco, CA.

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Transcript

The working group was comprised of 65 co-authors. We had over 13 different working groups. It’s very difficult to distill out all of the guidance. It was published today in the Journal of Clinical Oncology. I would encourage you to check out the white paper that goes over updates and how to write your protocol from an eligibility perspective, from an endpoint perspective...

The working group was comprised of 65 co-authors. We had over 13 different working groups. It’s very difficult to distill out all of the guidance. It was published today in the Journal of Clinical Oncology. I would encourage you to check out the white paper that goes over updates and how to write your protocol from an eligibility perspective, from an endpoint perspective. We declare new PSMA PET-based endpoints, for example, for documenting radiographic progression. We define new PSA endpoints, new nomenclature, such as the use of the word androgen pathway modulation rather than castration-resistant or sensitive. That’s a more patient-centric term for the field. So we’re excited to, every 10 years, have these updates for the field and to help us in the development of new therapies over the next decade.

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