Adherence and Persistence on Relugolix for the Treatment of Prostate Cancer in the US Medicare Fee-For-Service Population | Urology Practice

Real-World Study Confirms High Adherence to Oral Relugolix in Medicare Patients with Prostate Cancer

New Research Validates Practical Benefits of First Oral ADT Drug

Bottom Line Up Front: A major new study of over 5,000 Medicare patients found that men with prostate cancer showed excellent adherence to relugolix (Orgovyx), the first oral androgen deprivation therapy, with 93% maintaining proper medication adherence over 24 months. This real-world data supports the drug's practical utility beyond clinical trials.

A groundbreaking study published in the AUA Journals provides reassuring evidence that relugolix, the first and only oral androgen deprivation therapy (ADT) for advanced prostate cancer, demonstrates excellent patient adherence in real-world clinical practice. The research analyzed Medicare claims data from over 5,000 patients and found remarkably high rates of medication adherence and persistence.

Study Highlights

Dr. Stephen J. Freedland and colleagues examined Medicare fee-for-service administrative claims data from 2019-2023, focusing on 5,274 patients with prostate cancer who received relugolix. The study revealed several encouraging findings:

Adherence Rates: Among patients who remained on therapy, 93% maintained adherence (defined as filling prescriptions at least 80% of the time) throughout the 24-month study period. This high adherence rate was consistent regardless of whether patients had metastatic or non-metastatic disease.

Persistence Differences: Patients with metastatic prostate cancer stayed on relugolix longer than those with non-metastatic disease, with average treatment durations of 11.2 months versus 9.4 months, respectively. This difference likely reflects treatment protocols where metastatic patients receive continuous ADT while non-metastatic patients often receive intermittent therapy.

Real-World Validation: The study confirms that the excellent adherence rates seen in the clinical trial setting translate to everyday practice, addressing previous concerns about whether an oral daily medication would be as reliable as quarterly injections.

Broader Context: Growing Evidence for Relugolix

This Medicare study adds to mounting evidence supporting relugolix as a preferred ADT option. Recent data from multiple sources reinforces its clinical benefits:

The OPTYX Real-World Study: Presented at the 2025 Genitourinary Cancers Symposium, this ongoing observational study has enrolled 999 patients across diverse clinical settings. Preliminary findings show that both physicians (41.5%) and patients (36.4%) frequently choose relugolix specifically because they prefer oral administration over injections.

Cardiovascular Safety Profile: The landmark HERO trial demonstrated that relugolix provides a 54% lower risk of major adverse cardiovascular events compared to leuprolide (Lupron), a significant finding given that cardiovascular disease is now the leading cause of death in prostate cancer patients. This safety advantage has been consistently validated in subsequent analyses.

Superior Efficacy: Relugolix achieved sustained testosterone suppression in 96.7% of patients in the HERO trial, compared to 88.8% with leuprolide. The oral medication also provides rapid testosterone suppression without the initial testosterone surge associated with traditional LHRH agonists.

Clinical Practice Implications

These findings address a key concern that oncologists and urologists have had about oral ADT medications. Dr. Neal Shore, a leading prostate cancer specialist, previously noted questions about "men's ability to take a pill every day, as opposed to only having to get an injection of leuprolide or related drugs every few months."

The new Medicare data suggests these concerns may be unfounded. The 93% adherence rate matches or exceeds adherence rates for other daily oral cancer medications and demonstrates that patients can successfully manage daily dosing when properly supported.

Practical Advantages:

  • No need for quarterly clinic visits for injections
  • Immediate testosterone recovery upon discontinuation (important for intermittent therapy)
  • Reduced cardiovascular risk
  • Patient control and convenience

Current Treatment Landscape

Relugolix received FDA approval in December 2020 based on the HERO trial results and is now available as the only oral option for ADT. The drug works as a GnRH receptor antagonist, directly blocking testosterone production without the initial hormone surge seen with traditional LHRH agonists.

The OPTYX study, which completed enrollment in 2024, continues to follow patients for up to five years to provide long-term safety and effectiveness data. Early results show that 52% of patients receive relugolix in combination with other prostate cancer therapies, demonstrating its versatility across different treatment scenarios.

What This Means for Patients

For men facing ADT treatment decisions, this research provides important reassurance about the practicality of oral therapy. The high adherence rates suggest that most patients can successfully manage daily dosing, while the cardiovascular safety benefits may be particularly important for men with existing heart conditions.

Key Takeaways for Patients:

  • Daily oral medication shows excellent real-world adherence rates
  • Cardiovascular safety profile superior to injection alternatives
  • Rapid testosterone recovery when treatment stops
  • Eliminates need for quarterly injection appointments
  • Suitable for both metastatic and non-metastatic disease

Looking Ahead

The combination of strong clinical trial data and now robust real-world evidence positions relugolix as an increasingly important option in prostate cancer care. With over 90% of men in clinical trials having cardiovascular risk factors, the demonstrated cardiac safety benefits could make this the preferred choice for many patients.

As Dr. Alicia Morgans of Northwestern University noted, relugolix represents "a new standard of care for men with advanced prostate cancer" that "meaningfully and effectively lowered testosterone levels" while offering important safety advantages.

Sources and Additional Information

Primary Study: Freedland, S.J., et al. "Adherence and Persistence on Relugolix for the Treatment of Prostate Cancer in the US Medicare Fee-For-Service Population." AUA Journals, 2025.

Related Research and News:

  1. Shore, N.D., et al. "Oral Relugolix for Androgen-Deprivation Therapy in Advanced Prostate Cancer." New England Journal of Medicine, 2020; 382(23):2187-2196. https://www.nejm.org/doi/full/10.1056/NEJMoa2004325
  2. FDA Approval Information. "FDA approves relugolix for advanced prostate cancer." December 18, 2020. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-relugolix-advanced-prostate-cancer
  3. National Cancer Institute. "FDA Approves Relugolix for Advanced Prostate Cancer." Cancer Currents Blog. https://www.cancer.gov/news-events/cancer-currents-blog/2021/fda-relugolix-prostate-cancer-androgen-deprivation-therapy
  4. OPTYX Study presentation. "Clinical characteristics and preferences for initiating relugolix in a cohort of US patients in real-world care settings." 2025 ASCO Genitourinary Cancers Symposium. https://www.urotoday.com/conference-highlights/asco-gu-2025/asco-gu-2025-prostate-cancer/158161-asco-gu-2025-optyx-study-clinical-characteristics-and-preferences-for-initiating-relugolix-in-a-cohort-of-us-patients-in-real-world-care-settings.html
  5. "Relugolix Shows Strong Adherence in Medicare Patients With Prostate Cancer." Targeted Oncology, February 18, 2025. https://www.targetedonc.com/view/relugolix-shows-strong-adherence-in-medicare-patients-with-prostate-cancer
  6. "OPTYX Study Offers Preliminary Glance Into Real-World Use of Relugolix in Advanced Prostate Cancer." OncLive, February 17, 2025. https://www.onclive.com/view/optyx-study-offers-preliminary-glance-into-real-world-use-of-relugolix-in-advanced-prostate-cancer
  7. Shore, N.D., et al. "Impact of Concomitant Cardiovascular Therapies on Efficacy and Safety of Relugolix vs Leuprolide: Subgroup Analysis from HERO Study in Advanced Prostate Cancer." Advances in Therapy, 2023. https://link.springer.com/article/10.1007/s12325-023-02634-7
  8. Shirley, M. "Relugolix: A Review in Advanced Prostate Cancer." Target Oncology, 2022. https://pmc.ncbi.nlm.nih.gov/articles/PMC10198864/
  9.  Adherence and Persistence on Relugolix for the Treatment of Prostate Cancer in the US Medicare Fee-For-Service Population | Urology Practice

For More Information:

  • Consult with your oncologist or urologist about whether relugolix might be appropriate for your treatment plan
  • Visit www.cancer.gov for comprehensive prostate cancer information
  • Contact the IPCSG for additional patient resources and support


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