Dr. Paul Dato, MD - Provenge Immunotherapy

Dr. Dato presented a talk at the October IPCSG meeting. Dendreon, who sponsored this presentation required that no recording be made. Here are some notes on the topic presented. Linked above is a prior presentation in May of 2023 on Provenge by Dr. Jim Hsiang, and what follows is a summary of that presentation.

Revolutionary Treatment Harnesses Body's Own Immune System

Dr. Jim Tsang, a radiation oncologist from Corpus Christi Urology Group and Cancer Center, explained how Provenge represents a fundamentally different approach to fighting prostate cancer. "This is personalized medicine at its finest," Dr. Tsang told the audience. "We're using your own immune cells to train your body to recognize and attack cancer cells."

Unlike traditional treatments, Provenge does not lower PSA levels—a concept Dr. Tsang emphasized multiple times. "For the first time, we're asking you to reprogram your thinking about PSA," he explained. "Provenge works by activating your immune system to kill cancer cells, and that mechanism doesn't correlate with a drop in PSA. But more importantly, it improves overall survival—and that's the endpoint we really want."

Earlier Treatment Yields Dramatically Better Results

The presentation revealed compelling evidence that timing matters significantly with Provenge therapy. While the original Impact Trial showed a 4.1-month survival benefit, subsequent analysis told a more nuanced story.

"When we looked at patients treated at different PSA levels, we discovered something remarkable," Dr. Tsang said. Patients with PSA levels below 22 experienced a 13-month improvement in survival. Most dramatically, real-world data from recent studies showed patients with PSA under 5.27 achieved an impressive 48-month (four-year) survival benefit.

A large real-world study of 6,000 Medicare beneficiaries demonstrated that Provenge patients survived 35.2 months compared to 20.7 months for comparison groups—a difference of 14.5 months.

Addressing Health Disparities: Good News for African-American Patients

Dr. Tsang highlighted important findings from the PROCEED Registry study showing that African-American men—who face 1.7 times greater risk of prostate cancer diagnosis and 2.4 times higher death rates—actually responded better to Provenge than Caucasian patients at similar PSA levels.

"This addresses a critical health disparity," Dr. Tsang noted. "African-American men demonstrated greater benefit from Provenge treatment across all PSA ranges studied."

Side Effects Generally Mild and Manageable

Most patients experience mild to moderate side effects that resolve within one to two days, including:

Chills and rigors during infusion
Fatigue
Headache
Fever
Joint aches

Dr. Tsang noted that pre-medication with Tylenol and antihistamines helps minimize discomfort.

Who Qualifies for Provenge?

To be eligible, patients must have:

Metastatic disease confirmed by imaging (most commonly bone or lymph nodes)
Castrate-resistant prostate cancer (low testosterone but rising PSA)
No reliance on narcotics for cancer-related pain

"The key message is that earlier is better," Dr. Tsang emphasized. "We want to treat patients when they first become castrate-resistant and metastatic, not wait until PSA climbs very high."

A Patient's Journey: From PSA 143 to 0.04

Tom McKenzie, a patient ambassador for Dendreon (Provenge manufacturer), shared his remarkable five-year journey with the IPCSG audience.

The Wake-Up Call

McKenzie, a former multi-sport athlete who described himself as "Superman," admitted he hadn't seen a doctor in 16 years. "I had an understanding with doctors," he said with a smile. "If I could get out of bed in the morning, I probably didn't need one."

That changed when persistent pelvic pain led him to schedule a physical. The results were shocking: PSA of 143. Scans revealed extensive disease—involvement in pelvic lymph nodes, seminal vessels, bladder surface, and a spot on his rib.

"The urologist who did my biopsy took my wife Debbie aside and gave her a very dire prognosis," McKenzie recalled. "He pretty much told her we needed to get our things in order. But I'm a fighter, and that was way at the end of the fight before I had even thrown my first punch."

Building a Treatment Plan

McKenzie's oncologist at Duke Cancer Center delivered a message that became his mantra: "There are a lot of tools in the toolbox for treating prostate cancer, and there's not a single one we can't use on you."

His treatment sequence included:

ADT (androgen deprivation therapy)
Chemotherapy—"my lost year" due to brain fog and fatigue
Provenge when PSA rose to about 5 after 18 months
Multiple ADT adjustments
Two rounds of targeted radiation (SBRT)

The Provenge Experience

McKenzie described the treatment process in practical terms. During leukapheresis at a Red Cross center, "I half expected Dr. Frankenstein to step out from behind a screen," he joked about the machinery separating his blood cells.

He and his wife Debbie had an emotional moment when an overnight delivery arrived with his processed cells. "We could see it was from Dendreon, and we looked at each other knowing my dose was in that box. Just thinking about what went behind the scenes in those couple of days to get it ready—Debbie teared up. Superman got a little misty too, but he held it together."

McKenzie tolerated the treatment well, experiencing mainly fatigue after leukapheresis that resolved by the next day.

Five Years Later: Thriving, Not Just Surviving

More than five years after Provenge treatment, McKenzie's latest PSA (four weeks prior to the presentation) was 0.04—down from 143 at diagnosis.

"The metastasis on my rib is completely gone," he reported. "My cancer is now pretty much confined to the prostate with a little regional involvement, and it's well-controlled."

Today, McKenzie maintains an active lifestyle: golfing 2-3 times weekly, playing competitive skeet in summer, and playing guitar and drums. "There's too much joy in this life to allow cancer to take it over," he said.

Words of Wisdom

McKenzie left the audience with practical advice drawn from his experience:

"Don't let cancer take over your life" - "Cancer is what you have, it is not who you are."

Advocate for yourself - "Ask questions. Make sure you understand the disease and what tools are available."

Include mind-body-spirit approach - "I practice daily meditation. Your mind and body are inextricably linked."

Keep a sense of humor - "My brother used to say it's a long day without a laugh. Good things happen in your body when you laugh—science has proven that."

Remember the toolbox - "There are a lot of tools in the toolbox for treating prostate cancer, so hang in there and fight the fight. You can do it."

Insurance Coverage and Patient Assistance

Dr. Tsang noted that Provenge is covered by insurance, and patient assistance programs are available through organizations like the Patient Access Network. "It's like winning the lottery," he explained. "Some offices have staff who help patients access these funds at 7 AM when enrollment opens."

Important Clarification for Patients

One critical point Dr. Tsang emphasized: Provenge is not a cure—it's a treatment. "But it's an important treatment that can significantly extend survival and maintain quality of life," he said. McKenzie's journey over five-plus years demonstrates this potential.

The presentation also clarified that currently, Provenge is FDA-approved only for metastatic castrate-resistant disease, not hormone-sensitive prostate cancer, though researchers hope future trials may expand indications.

Questions from Members

IPCSG members asked thoughtful questions, including:

Whether Provenge could be converted to an mRNA vaccine approach (Dr. Tsang noted this is likely being researched post-COVID)
How to monitor treatment effectiveness without PSA changes (imaging and overall survival over time)
Whether second courses of Provenge are possible (theoretically yes, but requires more research)

Looking Ahead

The presentation concluded with both speakers emphasizing the importance of early detection, ongoing monitoring, and open communication with healthcare teams.

"Keep track of your PSA and scans," Dr. Tsang advised. "Treatment earlier is generally better for most therapies, and that's certainly true with Provenge."

For McKenzie, the message was simpler: "You're not on this journey alone. Fight the fight—you can do it."

Editor's Note: Provenge treatment is sponsored by Dendreon. This presentation was educational in nature. All treatment decisions should be made in consultation with your medical team based on your individual circumstances.

What Provenge Is

Provenge® (scientific name sipuleucel-T) is a type of personalized immunotherapy for men with advanced prostate cancer that has stopped responding to standard hormone-blocking medicines (sometimes called metastatic castration-resistant prostate cancer, or mCRPC).

Unlike chemotherapy or hormone pills, Provenge is made from your own immune cells. These cells are collected from your blood, trained in a special lab to recognize prostate-cancer cells, and then returned to your body by infusion.

The idea is to help your immune system “wake up” and attack the cancer more effectively.

How It Works

Cell collection: Blood is drawn through a procedure called leukapheresis to collect white blood cells.
Cell training: In the laboratory, your cells are mixed with a protein found in prostate-cancer cells (called prostatic acid phosphatase, or PAP) combined with a natural immune booster.
Infusion: A few days later, the activated cells are given back through an IV.
Repeat: This process happens three times, about two weeks apart.

What the Research Shows

Large clinical studies show Provenge can help men live longer—by about 4 months on average—compared with men who did not receive it.

However, it usually does not shrink tumors or lower PSA levels quickly, so the benefits may not be obvious right away.

It works best in men who:

Have few or no cancer-related symptoms (like pain or fatigue)
Still feel well and have good daily function
Have not had chemotherapy yet

Common short-term side effects are chills, fever, tiredness, or muscle aches the day of infusion. These usually pass within a day or two.

Who Makes Provenge

Provenge was developed by a Seattle company called Dendreon. The company has changed ownership several times since the treatment was approved by the U.S. Food and Drug Administration (FDA) in 2010.

Provenge is still available in the U.S., though not every cancer center offers it because it requires special equipment and coordination with a Provenge processing center.

In 2024, Dendreon reported a data-security breach involving some patient information, but there has been no evidence of harm to patients or interruption in treatment.

What’s New in Research (2024–2025)

Scientists are studying ways to make Provenge work even better, including:

Combining it with other treatments like hormone blockers, targeted drugs, or new immune therapies (called checkpoint inhibitors)
Finding better timing—using it earlier, when cancer is smaller or less aggressive
Tracking immune signals in the blood to see who benefits most

These studies are ongoing, so Provenge’s main approved use today is still as a stand-alone therapy for men with few symptoms and good overall health.

Costs and Insurance

Provenge is expensive (around $90,000 per full course), but Medicare and many private insurers cover it when used for FDA-approved prostate-cancer cases.
Your doctor’s office can check coverage and help arrange the required cell-collection appointments.

Dr Paul Dato and Patient Access

Dr Paul E. Dato, a urologist in San Diego, has helped lead programs that connect community clinics with Provenge treatment centers. Doctors like Dr Dato focus on helping patients understand their options and coordinate with infusion sites so treatment runs smoothly.

Questions to Ask Your Doctor

Am I a good candidate for Provenge?
Can I have it before or after hormone therapy or chemotherapy?
Where would my cells be processed?
How long will each step take?
Will my insurance cover it?

The Bottom Line

Provenge is a proven but modestly effective treatment for certain men with advanced prostate cancer.
It doesn’t cure the disease, but it can help men live longer and feel well longer with few serious side effects.

It works best early in the advanced stage—so talk with your cancer team soon if you think it might be right for you.

Trusted Sources & References

U.S. Food & Drug Administration. PROVENGE (sipuleucel-T) product information: FDA.gov

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