“It was the worst day of my life, and my family’s life,” said Tampa Bay veterinarian Dr. Norman Busciglio. He was referring to the day he was diagnosed with prostate cancer in October 2012. He underwent a radical prostatectomy, a surgical procedure to remove the prostate gland and tissues surrounding it, followed by hormone-based therapy, chemotherapy and radiation therapy. However, six years later tests revealed the cancer had spread to his bones.

“It was incredibly painful, especially in my back,” he recalled.

Busciglio underwent more chemo and hormone therapy, but it didn’t seem to help. His doctors sent him to New York City where he learned about a clinical trial for a new targeted therapy utilizing nuclear medicine.  Unfortunately, the trial was only available in Germany and would require Busciglio to be overseas for six months.

“I didn’t want to be away from my family or veterinary practice work for that long, so I monitored clinicaltrials.gov every night,” he said. “I saw the trial opened in California, so I called there but no luck. Then it popped up in New Orleans. I called Tulane’s Urology Department and was able to make an appointment.”

The trial his doctors recommended is the VISION trial, which is evaluating the radioligand therapy 177Lu-PSMA-617 in patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer. Radioligand therapy combines a targeting compound that binds to markers expressed by tumors—In this instance PSMA—with a radioactive isotope that can emit therapeutic radiation to kill cancer cells while limiting damage to the surrounding normal tissue. 

Once Busciglio met with doctors at Tulane, he was sent to Houston for pre-qualifying tests at the Excel Diagnostics & Nuclear Oncology Center.

“The way it was explained to me is they wanted to see if the therapy could bind with my cells and target the cancer,” he said.

About 10 days later, Busciglio got the good news he was accepted for the trial. He received radioligand therapy infusions every six weeks for six cycles. Since the treatment is radioactive, he had to self-isolate for three days after each cycle. He started his therapy at Tulane, but after his second infusion he learned the trial had opened at Moffitt Cancer Center. So, he completed his last four cycles in Tampa under the care Dr. Jingsong Zhang, interim vice chair of the Genitourinary Oncology Department.

“The therapy has been life changing for me. After the first shot, my pain went away. My back and body no longer ached. It was amazing,” Busciglio said. “My doctors say I am the poster child for this therapy.”

“Prostate cancer is the second-leading cause of death in men in the U.S. And those with metastatic prostate cancer have a 3 in 10 chance of surviving five years. New therapies, like 177Lu-PSMA-617, are greatly needed for this group of patients,” said Dr. Ghassan El-Haddad, associate member of the Diagnostic Imaging and Interventional Radiology Department and investigator overseeing the VISION trial at Moffitt.

Results from the phase 3 VISION trial were presented earlier this month during the 2021 American Society of Clinical Oncology Annual Meeting. The study results show the new drug reduced the risk of death by 38% in patients with advanced prostate cancer despite being heavily pretreated. Progression of the disease was reduced by 60%.

Busciglio is nearly two years post therapy and says his cancer is stable and his prostate-specific antigen (PSA) level, a figure often used to follow the evolution of prostate cancer, is non-detectable.

“Through this whole experience, my wife, my daughters and I remained positive. It was the only way to get through this,” he said.

He added that he continued to work at his veterinary office throughout his therapy and worked out five days a week to help him stay strong and healthy.  

The U.S. Food and Drug Administration granted breakthrough therapy designation to 177Lu-PSMA-617 on June 17. This will accelerate the review and approval process. A decision could be made by the end of the year.