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Dose-intensified radiation therapy fails to provide better outcomes in prostate cancer

Presented by
Prof. Pirus Ghadjar, Charité Universitätsmedizin Berlin, Germany
ASCO GU 2021
Phase 3, SAKK 09/10
A dose-intensified salvage radiotherapy protocol administered to men with adenocarcinoma of the prostate who had undergone radical prostatectomy failed to prolong freedom from biochemical progression of the disease.

Prof. Pirus Ghadjar (Charité Universitätsmedizin Berlin, Germany) presented the results of the SAKK 09/10 trial (NCT01272050), an open-label, multicentre, randomised phase 3 trial that sought to compare the effectiveness of 2 salvage radiotherapy regimes for the treatment of patients who had relapsing prostate cancer following radical prostatectomy [1]. Relapse was defined as 2 consecutive rises in prostate-specific antigen (PSA) level with the second rising value >0.1 ng/mL, or 3 consecutive rises.

Patients (n=350) were randomised 1:1 to receive either conventional-dose radiotherapy (64 Gray [Gy] in 32 fractions administered over 6.4 weeks) or dose-intensified radiotherapy (70 Gy in 35 fractions administered over 7 weeks) directed to the prostate bed.

The primary endpoint was freedom from biochemical progression (defined as PSA ≥0.4 ng/mL and rising). At 6 years, freedom from biochemical progression was 62.3% versus 61.3% for the 64 Gy versus the 70 Gy arm, respectively, with an HR of 1.14 (95% CI 0.82–1.60; log-rank P=0.44).

Secondary endpoints included clinical progression-free survival, time to hormonal treatment, and overall survival. These outcome measures were not significantly different between the treatment groups.

Genitourinary (GU) and gastrointestinal (GI) toxicity were tracked as well. GU toxicity was not significantly different between the groups; however, the higher-dose protocol was associated with increased GI toxicity.

  1. Ghadjar P. Dose-intensified versus conventional dose-salvage radiotherapy for biochemically recurrent prostate cancer after prostatectomy: Six-year outcomes of the SAKK 09/10 randomised phase 3 trial. Abstract 194, ASCO Genitourinary Cancers Symposium, 11–13 February 2021.


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