Phase 3 Study Weighs Benefits of Standard Drugs Plus Surgery or Radiation Therapy

Phase 3 Study Weighs Benefits of Standard Drugs Plus Surgery or Radiation Therapy

The first patients have been enrolled in a Phase 3 clinical trial to evaluate if combining either prostate removal surgery or radiation therapy with standard systemic therapy delays cancer progression and improves survival of patients with advanced prostate cancer that has spread to other parts of the body.

Enrollment has begun at the LSU Health New Orleans Scott Cancer Center.

The study is a multi-center open-label Phase 3 trial (NCT03678025) sponsored by the National Cancer Institute and the Southwest Oncology Group, which intends to enroll 1,273 patients at several centers across the U.S. Recruitment is open now for patients whose cancer has spread to distant parts in the body within the past six months and who have not received prior local treatment.

The study is based on the hypothesis that targeting the original tumor site by prostatectomy, a prostate removal surgery, or radiation therapy can lower the chances of cancer growing or spreading.

“Currently, when a patient presents to the doctor when the cancer has already spread to the bone or other organs, the standard of care is to treat them with medications called ‘systemic’ therapies, which are carried by the bloodstream to cancer cells wherever they are. Patients with metastatic prostate cancer are not usually offered therapy targeting the prostate where the cancer originated, and often the bulk of the cancer still remains,” Scott Delacroix, Jr., MD, principal investigator in the study, said in a press release. Delacroix is director of Urologic Oncology at LSU Health New Orleans School of Medicine. 

“The main question being asked is, does treatment of the residual cancer left within the prostate affect how long a patient will survive and with good quality of life,” said Delacroix.

The trial will compare the survival and symptom progression of patients in two arms: Those treated by the current standard of care, standard systemic therapy; and those who will receive the latter therapy combined with either prostatectomy or radiation therapy.

Patients will be assigned randomly to one of the treatment arms: Those receiving combo therapy will undergo prostatectomy within eight weeks after randomization; or radiation therapy within four weeks of randomization. The choice of surgery or radiation is left to the participant and his doctor. All patients will receive treatment throughout the entire course of their disease.

Adding surgery or radiation therapy to standard care could prolong patients’ lives, but also may cause additional side effects. A smaller Phase 2 study conducted earlier at MD Anderson Cancer Center gave promising results and prompted the design of this new, larger trial.

“This study is the largest interventional NCI clinical trial for men who present with [metastatic] prostate cancer in the past 25 years,” added Delacroix. “It has the potential to impact the treatment for men with [metastatic] prostate cancer in multiple ways including not only answering the question of improving survival, but also potentially finding distinct groups of patients with prostate cancers that behave and respond differently to therapies.”

More information about this study is available at