Age Shouldn't Limit Treatment Options for Castration-Resistant Prostate Cancer

Results Comparison

Age Shouldn't Limit Treatment Options for Castration-Resistant Prostate Cancer

Japanese Research Reveals Comparable Outcomes for Older Patients

A newly published study brings encouraging news for older men with castration-resistant prostate cancer (CRPC). The ENABLE trial, conducted across multiple centers in Japan, has demonstrated that second-generation androgen receptor signaling inhibitors (ARSIs) can be equally effective and safe in elderly patients compared to their younger counterparts.

The research, published on April 3, 2025, in the journal The Prostate, specifically examined outcomes with enzalutamide (ENZ) and abiraterone plus prednisolone (ABI) in patients aged 75 and older versus those under 75 with CRPC.

Key Findings: Age Is Not a Limiting Factor

The study analyzed 184 patients, with 107 classified as older (≥75 years) and 77 as younger (<75 years). Investigators found no significant differences in survival outcomes between these age groups:

  • Time to PSA progression was 21.2 months for older patients versus 15.2 months for younger patients
  • Overall survival was 37.8 months for older patients compared to 33.7 months for younger patients
  • Adverse events were similar across age groups: 68% of older patients and 61% of younger patients experienced adverse events of any grade

"This is valuable information for our community," says Dr. James Thompson, medical advisor to IPCSG. "Many clinical trials exclude older patients, creating a knowledge gap about treatment efficacy in this population. The ENABLE study helps fill that gap."

Enzalutamide: Potentially Better for Older Patients?

Among the older patient group, those receiving enzalutamide showed a longer time to PSA progression (21.2 months) compared to those on abiraterone (10.1 months). However, overall survival was slightly better in the abiraterone group (44.7 vs. 37.8 months).

The study authors concluded that enzalutamide may be a more suitable option for older patients due to its higher PSA response rate, though both medications demonstrated acceptable safety profiles.

The Bigger Picture: How This Fits with Other Research

This study adds to a growing body of evidence about these treatments. A meta-analysis published in the journal Frontiers in Oncology found that enzalutamide generally showed better efficacy than abiraterone for radiographic progression-free survival and time to PSA progression, though overall survival benefits were similar 1.

Another relevant study published in The Lancet Oncology examined the optimal sequencing of these medications. Researchers found that using abiraterone first followed by enzalutamide upon progression provided greater clinical benefit than the reverse sequence 2.

Real-world evidence from the Veterans Health Administration also supports these findings. Their analysis showed that both medications are effective treatment options for chemotherapy-naïve patients with metastatic CRPC 3.

What This Means for Patients

For IPCSG members, particularly those over 75, this research provides reassurance that age alone should not determine treatment options. Both enzalutamide and abiraterone can be effective and tolerable treatments for CRPC regardless of age.

"These findings emphasize the importance of individualized treatment decisions based on a patient's overall health status rather than chronological age," notes Dr. Thompson.

References

  1. Wei Z, Chen C, Li B, Li Y, Gu H. Efficacy and Safety of Abiraterone Acetate and Enzalutamide for the Treatment of Metastatic Castration-Resistant Prostate Cancer: A Systematic Review and Meta-Analysis. Front Oncol. 2021;11:732599. https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2021.732599/full
  2. Khalaf DJ, Annala M, Taavitsainen S, et al. Optimal sequencing of enzalutamide and abiraterone acetate plus prednisone in metastatic castration-resistant prostate cancer: a multicentre, randomised, open-label, phase 2, crossover trial. Lancet Oncol. 2019;20(12):1730-1739. https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(19)30688-6/fulltext
  3. George DJ, Sartor O, Miller K, et al. Survival outcomes in patients with chemotherapy-naive metastatic castration-resistant prostate cancer treated with enzalutamide or abiraterone acetate. Prostate Cancer and Prostatic Diseases. 2021. https://www.nature.com/articles/s41391-021-00318-3
  4. Ryan CJ, Smith MR, Fizazi K, et al. Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naive men with metastatic castration-resistant prostate cancer (COU-AA-302): final overall survival analysis of a randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol. 2015;16:152–60. https://pubmed.ncbi.nlm.nih.gov/25601341/
  5. Beer TM, Armstrong AJ, Rathkopf DE, et al. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med. 2014;371:424-433. https://www.nejm.org/doi/full/10.1056/NEJMoa1405095
  6. Okamura T, Izumi K, Kurokawa S, et al. Efficacy and Safety of Enzalutamide and Abiraterone Plus Prednisolone in Elder Castration-Resistant Prostate Cancer Patients: A Sub-Analysis From the ENABLE Study. The Prostate. 2025. https://doi.org/10.1002/pros.24897

Efficacy and Safety of Enzalutamide and Abiraterone Plus Prednisolone in Elder Castration‐Resistant Prostate Cancer Patients: A Sub‐Analysis From the ENABLE Study - Okamura - The Prostate - Wiley Online Library

First published: 03 April 2025
https://doi.org/10.1002/pros.24897

ABSTRACT

Background

Clinical trials rarely focus on elder patients with castration-resistant prostate cancer (CRPC), and data on the outcomes of second-generation androgen receptor signaling inhibitors (ARSIs) remain limited.

Methods

The ENABLE study for prostate cancer was an investigator-initiated, multicenter, randomized controlled trial conducted in Japan to compare enzalutamide (ENZ) and abiraterone plus prednisolone (ABI). This sub-analysis was performed to evaluate the efficacy and the safety profiles between patients aged ≥ 75 (older) and < 75 years (younger), and then between the ENZ and ABI arms in the older and the younger cohort separately.

Results

The ENZ arm included 41 younger and 51 older patients, while the ABI arm included 36 younger and 56 older patients. No significant differences in survival endpoints were observed between younger and older patients. Median time to prostate-specific antigen (PSA) progression (TTPP) was 15.2 months for younger and 21.2 months for older patients (HR 0.84, 95% CI 0.53–1.33, p = 0.4647). Median overall survival (OS) was 33.7 months for younger and 37.8 months for older patients (HR 0.80, 95% CI 0.50–1.29, p = 0.3651). Among older patients (n = 107), the ENZ arm had a TTPP of 21.2 months compared to 10.1 months for the ABI arm and an OS of 37.8 months compared to 44.7 months for the ABI arm (p = 0.1506 and p = 0.9321, respectively). Any grade and grade ≥ 3 adverse events were observed in 47 (61%) and 11 (14%) younger patients and 73 (68%) and 18 (17%) older patients, respectively. No significant differences were found in any grade or grade ≥ 3 adverse events between younger and older patients (p = 0.3487 and p = 0.6885, respectively).

Conclusions

ARSIs demonstrated similar efficacy and safety in both younger and older patients. ENZ may be a more suitable option for older patients due to its higher PSA response rate.

Clinical Trial Registration

This trial was registered with the University Hospital Medical Information Network (UMIN) Center under identifier UMIN000015529.

 

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