Patients with prostate cancer who received 18 months of androgen deprivation therapy were more likely to recover their serum testosterone levels and to recover quicker than those who received 36 months of therapy.
Eighteen months should be the preferred length of androgen deprivation therapy (ADT) therapy for patients with high-risk prostate cancer (HRPC) vs 36 months, according to findings from the randomized phase 3 Prostate Cancer Study IV (NCT00223171) presented at the 2023 ASCO Quality Care Symposium.1
“Eighteen months of ADT should be the preferred duration since a significantly faster and a higher proportion of patients recover a normal testosterone level with the shorter schedule without a detriment in long-term outcomes, as previously reported,” Abdenour Nabid, MD, of the Centre Hospitalier Universitaire de Sherbrooke Canada, wrote in the poster, emphasizing that, “in patients cured from high-risk prostate cancer, testosterone recovery is associated with a better quality of life.”
At a median follow-up time of 14 years, 52% (n = 140/269) of patients overall recovered to a normal testosterone level. In the 18-month arm specifically (n = 166), 56.6% recovered to a normal testosterone level. In the 36-month arm (n = 103), 44.7% of patients recovered testosterone to a normal level (P < .056).
Among those who regained their normal testosterone level, the median time to recovery, between the 2 arms was 3 years (IQR, 2.5-3.6) vs 5 years (IQR, 4.5-6.0), again supporting the 36-month duration (P < .001).
When comparing the quality of life in survivors, those who achieved testosterone recovery had significant improvements in their physical (P = .0096), role (P = .0076), emotional (P < .0001), fatigue (P < .0001), pain (P = .0002), dyspnea (P = .0005), insomnia (P = .0103), diarrhea (P = .0042), and financial difficulties scores (P < .0001), compared with those who did not reach testosterone recovery, according to their EORTC30 scores.
The trial included 630 patients who were randomly assigned to receive either 18 or 36 months of ADT along with pelvic- and prostate-directed radiotherapy. Ultimately, 361 patients were excluded from this analysis for either not having undergone 18 or 36 months of ADT, for surviving less than 1 year, or not having their testosterone measured at baseline or during follow up. Additionally, patients with biochemical failure or evidence of metastatic or recurrent disease were excluded, in addition to those who did no complete the quality-of-life questionnaire.
Investigators defined normal T values as 9 to 25 nmol/ml and abnormal T values as less than 9 nmol/ml.
The EORTC30 was used to assess quality of life; this questionnaire assesses 20 different items which are grouped into 9 scales. Patients were asked to complete their patient-reported outcome (PRO) assessments before their first treatment, every 6 months during ADT, 4 months after ADT, and then once annually for 5 subsequent years.
The percentage of patients who completed the quality-of-life questionnaires was 83.9% overall. There was better compliance (P < .001) in the 36-month group (86.4%) than in the 18-month group (81.8%).
For patients with localized, high-risk prostate cancer, ADT plus radiotherapy is standard of care. However, long-course ADT is associated with a high toxicity burden.2
Previous reports from the trial demonstrated that 18 months of ADT yielded similar overall survival outcomes (OS) vs 36 months. The 5-year OS rates, respectively, were 86% vs 91% (P = .07).
In this updated analysis, PRO outcomes demonstrated that not only were survival outcomes similar, but patients with a shorter course of ADT had fewer long-term toxicities in survivorship.
References
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