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Two RCCA Oncologists Explain How Radiopharmaceuticals Are Transforming Advanced Prostate Cancer Care

An innovative approach to administering radiation therapy via infusion is helping patients with advanced prostate cancer live longer while maintaining their quality of life, say two medical oncologists with Regional Cancer Care Associates (RCCA).

“Radiation long has played a central role in treating the metastases that mark advanced forms of prostate cancer, with the treatment typically delivered by an external beam directed at a specific location in the body or by implantation of small radioactive pellets or wires in or near a tumor,” explains Bhavesh Balar, MD, a board-certified medical oncologist and hematologist. “More recently, sophisticated therapies known as radiopharmaceuticals are being used to deliver radiation directly to the site of metastases, which the radiation then attacks with minimal impact on surrounding healthy tissues,” adds Dr. Balar, who practices in the Freehold, NJ, office of RCCA, one of the nation’s largest networks of oncology specialists. RCCA serves patients at locations throughout New Jersey, Connecticut, Maryland, and the Washington, D.C., area.

Prostate cancer patient smiling after treatment with radiopharmaceuticals

Pluvicto® and Metastatic Prostate Cancer Treatment

Dr. Balar and his colleagues at RCCA’s Freehold office are using one of those radiopharmaceuticals, Pluvicto® (lutetium Lu 177 vipivotide tetraxetan), to treat men with metastatic castration-resistant prostate cancer, or mCRPC. The physician explains, “In mCRPC, a patient’s prostate cancer has spread – or become metastatic – despite the administration of hormonal therapy that has reduced the androgens that initially fuel prostate cancer to below what is considered a ‘castrate’ level, hence the term ‘castration-resistant.’”

Pluvicto is given in six infusions six weeks apart. An imaging study must show that the patient has tumors that express a protein called prostate-specific membrane antigen, or PSMA.1 Dr. Balar explains, “Identifying the presence of PSMA via imaging is critical because, upon infusion, Pluvicto finds and binds to PSMA-expressing cells and emits radiation that induces DNA damage that can cause those cells to die.”

When the Food and Drug Administration (FDA) initially approved Pluvicto in March 2022, its use was limited to men with mCRPC who already had been treated with a type of hormonal therapy known as an androgen receptor inhibitor and with chemotherapy. However, in March 2025, the FDA dropped the requirement that men had to have received chemotherapy before being considered for Pluvicto.2

Robert S. Alter, MD, hematologist and medical oncologist at RCCA
“Along with immunotherapies, other targeted therapies, and similar innovations, radiopharmaceuticals are part of a dramatic expansion of the options we have to treat cancer and to achieve better outcomes for our patients.”
— Robert Alter, MD

“This FDA approval of an earlier, expanded role for Pluvicto in mCRPC offers men with advanced prostate cancer more options. While chemotherapy will remain the preferred choice for some based on their clinical status, many will be able to receive treatment with Pluvicto rather than, or at least before, chemotherapy,” says Dr. Balar.

The medical oncologist explains that the FDA’s initial approval of Pluvicto in 2022 was based on results from the Phase 3 VISION trial. In that study, overall survival for patients receiving Pluvicto plus their standard prostate cancer therapies was 15.3 months, versus 11.3 months for men in the control group who received just the standard prostate cancer therapies, with that difference being statistically significant.3 He adds that the FDA’s March 2025 decision to drop the requirement for prior chemotherapy was based on findings from the Phase 3 PSMAfore trial. In that study of 468 patients with mCRPC, the primary endpoint was radiographic progression-free survival (rPFS), which measures how long study participants live with no imaging evidence that their cancer has spread. In PSMAfore, the patients randomly assigned to the Pluvicto group had a median 9.3 months of rPFS, versus 5.5 months in patients receiving hormonal therapy, which was a statistically significant difference.4

Side Effects Reported with Pluvicto

The medical oncologist notes that the most common side effects reported by patients receiving Pluvicto in the two studies included fatigue, nausea, constipation, dry mouth, decreased appetite, and back pain.1-4 In the great majority of cases, those side effects were deemed to be Grade 1 or 2 adverse events, meaning that they were mild to moderate in nature.1,2 “We take side effects quite seriously, and work with patients on strategies to prevent problems and to relieve or minimize them should they occur,” Dr. Balar says. The physician adds that patients are advised to limit close contact, meaning less than three feet, from most other household members for two days after receiving Pluvicto and to limit such contact with children and pregnant women for seven days after treatment.

Pluvicto Offers a Chance to Delay or Avoid Chemotherapy

He continues, “Given the efficacy that Pluvicto has shown in clinical trials, the typically mild or moderate nature of its side effects, the potential it offers many men to avoid or defer chemotherapy, and the convenience of receiving six infusions in an office-based setting, I believe that Pluvicto is an important option for men with mCRPC and their physicians to consider.”

Xofigo®: Another Radiopharmaceutical Option for mCRPC

RCCA medical oncologist and hematologist Robert Alter, MD, has long experience employing another targeted radiopharmaceutical, Xofigo® (radium Ra 223 dichloride), to treat mCRPC.

Dr. Alter, who practices at RCCA’s Hackensack and North Bergen, NJ, offices, notes that while Xofigo is similar to Pluvicto in a number of ways, there are three important differences between the therapies.5 “First, Xofigo is not approved for patients known to have visceral metastases, meaning tumors located in soft tissue such as the liver, lungs, or brain. Its use is restricted to symptomatic tumors in the bone, which is the most common site – and typically the first site – of prostate cancer metastases. Second, patients do not need to have PSMA-expressing tumors to receive Xofigo. As long as imaging studies show bone metastases – and do not identify visceral metastases – a patient is a candidate for the therapy. Third, in approving Xofigo, the FDA did not require that patients had to have received chemotherapy or any other type of therapy. As a result, Xofigo can be an alternative to chemotherapy for some patients.”

Bhavesh Balar, MD, hematologist and medical oncologist at RCCA
“In addition to extending survival, Pluvicto has been shown to more than double the time that men live without disease progression, relative to patients receiving standard prostate cancer therapies.”
— Bhavesh Balar, MD

The medical oncologist explains that in the Phase 3 ALSYMPCA trial that led to the FDA’s 2013 approval of Xofigo, patients receiving the therapy plus their standard prostate cancer treatments lived 3.5 months longer than patients on the standard therapies alone (14.9 months versus 11.3 months).6 “Beyond that survival benefit, Xofigo was well-tolerated by patients in the trial, and my own experience with the therapy confirms that the side effects generally are mild and can be treated effectively,” Dr. Alter says. He adds that the most common adverse events reported in ALSYMPCA included nausea, anemia, fatigue, diarrhea, and constipation.6

“Xofigo is administered in six intravenous injections given four weeks apart. The actual administration itself takes about one minute, and patients typically can be in and out of the office in well under an hour,” Dr. Alter notes. He adds that the Xofigo prescribing information does not cite the need to avoid contact with others after receiving a treatment, although patients are advised to use contraception if they are sexually active with women of reproductive potential because of concerns about the effect of the therapy on an embryo or fetus.6

Other Radiopharmaceuticals for Prostate Cancer

The physician says, “In addition to Xofigo and Pluvicto, a number of other radiopharmaceuticals are in late stages of evaluation in prostate cancer. Further, another radiopharmaceutical, Lutathera®, has been approved to treat neuroendocrine tumors in the gastrointestinal tract7, and similar agents are being investigated for a wide variety of solid tumors and hematologic malignancies.”

Dr. Alter notes, “While each radiopharmaceutical has its own unique mechanism of action and role, these therapies share several features that should be sources of great encouragement to patients. First, they are highly targeted, enabling us to truly individualize the care we offer patients. Second, because they deliver radiation in such a precise manner, they typically have a minimal negative impact on surrounding healthy tissues. Third, they generally are administered over a limited number of sessions spaced a few weeks apart, offering patients not only efficacy but also convenience. Along with immunotherapies, other targeted therapies, and similar innovations, radiopharmaceuticals are part of a dramatic expansion of the options we have to treat cancer and to achieve better outcomes for our patients.”

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Dr. Alter and Dr. Balar are among 100+ medical oncologists and hematologists who practice with RCCA at 25 locations across New Jersey, Connecticut, Massachusetts, Maryland, and the Washington, D.C., area. RCCA’s cancer specialists see more than 30,000 new patients each year and provide care to more than 265,000 established patients, collaborating closely with those patients’ other physicians. RCCA physicians offer patients innovative therapies, including immunotherapies and targeted therapy, as well as access to approximately 300 clinical trials. In addition to serving patients who have solid tumors, blood-based cancers, and benign blood disorders, RCCA care centers also provide infusion services to people with a number of non-oncologic conditions—including multiple sclerosisCrohn’s diseaseasthma, iron-deficiency anemia, and rheumatoid arthritis—who take intravenously-administered medications.

To learn more about RCCA, call 844-410-7301, contact us or request an appointment.

References

  1. Pluvicto®(lutetium Lu 177 vipivotide tetraxetan) injection, for intravenous use. [Prescribing information.] October 2022. Advanced Accelerator Applications USA, Inc. Millburn, NJ.
  2. Novartis. FDA approves Novartis radioligand therapy Pluvicto® for earlier use before chemotherapy in PSMA-positive metastatic castration-resistant prostate cancer. March 28, 2025. Available at: https://www.novartis.com/news/media-releases/fda-approves-novartis-radioligand-therapy-pluvicto-earlier-use-chemotherapy-psma-positive-metastatic-castration-resistant-prostate-cancer. Accessed March 31, 2025.
  3. Sartor O, de Bono J, Chi KN, et al. Lutetium-177-PSMA-617 for metastatic castration-resistant prostate cancer. N Engl J Med. 2021;385:1091-103.
  4. Morris MJ, Castellano D, Hermann K, et al. 177Lu-PSMA-617 versus a change of androgen receptor pathway inhibitor therapy for taxane-naive patients with progressive metastatic castration-resistant prostate cancer (PSMAfore): a phase 3, randomised, controlled trial. Lancet. 2024;404:1227-1239.
  5. Xofigo®(radium Ra 223 dichloride) injection, for intravenous use. [Prescribing information.] December 2019. Bayer Healthcare Pharmaceuticals Inc. Whippany, NJ.
  6. Parker C, Nilsson S, Heinrich D, et al. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med. 2013;369:213-23.
  7. Lutathera (lutetium Lu 177 dotatate). [Prescribing information.] October 2024. Advanced Accelerator Applications USA, Inc. Millburn, NJ.

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