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Poster display session

2408 - Durable Prostate Cancer Control in a Randomized Trial of Optimal Timing of Dose Escalated (76 Gy) Radiation and 6 months ADT in Prostate Cancer

Date

10 Sep 2017

Session

Poster display session

Presenters

Shawn Malone

Citation

Annals of Oncology (2017) 28 (suppl_5): v269-v294. 10.1093/annonc/mdx370

Authors

S. Malone1, L. Eapen1, C. E1, W. Kendal1, J. Craig2, R. Macrae1, G. Perry1, J. Bowen3, S. Morgan1, O. Holmes1, S. Grimes2

Author affiliations

  • 1 Radiation Oncology, The Ottawa Hospital Cancer Centre, K1H8L6 - Ottawa/CA
  • 2 Clinical Trials, The Ottawa Hospital Cancer Centre, K1H8L6 - Ottawa/CA
  • 3 Radiation Oncology, N E Ontario Regional Cancer Centre, P3E5J1 - Sudbury/CA
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Resources

Abstract 2408

Background

A pooled analysis of trials using conventional dose radiation (XRT) indicates 6 months androgen deprivation therapy (ADT) improves prostate cancer survival in Gleason 7 disease (D’Amico, JCO 2011). The benefit of ADT when used in combination with dose escalated XRT remains controversial. In EORTC 22991 trial 6 months ADT improved disease free survival at all XRT dose levels (Bolla, JCO 2016). We present long-term results of dose escalated XRT (76 Gy) in combination with 6 months ADT in the context of a Phase 3 Trial evaluating the optimal timing of ADT in combination with XRT.

Methods

438 pts were entered on the trial. Inclusion criteria were cT1-T3, Gleason < 8, PSA < 30. Low risk pts were excluded. ADT consisted of 6 mo Total Androgen Blockade (TAB) with Goserelin and Biclutamide. Pts were randomized to upfront XRT (day 1 of ADT) or XRT after 4 months ADT. Median follow-up is 12 yrs. 10 yr overall Survival (OS), Cause Specific Survival (CSS) PSA Disease Free Survival (DFS) and Local DFS were estimated using Kaplan-Meier (KM) method.

Results

Clinical characteristics are as follows: mean age 69; 69% cT1-T2A, 31% cT2B-T3; 75% Gleason 7; mean PSA = 10. Protocol compliance: 96% of pts completed 6 mo TAB and 99% completed 6 mo Goserelin. 4% of patients stopped Biclutamide early (3% due to Grade 1-3 reversible liver toxicity). 4% of patients developed late Gr 3 proctitis. 10 yr results: PSA DFS 83%, CSS 98%, OS 76%, and local DFS 95%. The results by treatment arm will be presented in the near future.

Conclusions

The durable DFS, local control and CSS support the benefit of 6 mo ADT in combination with Dose Escalated (76 Gy) XRT. The favourable compliance, tolerance and toxicity data support this treatment approach. Potential survival benefits of ADT in intermediate risk prostate cancer will be evaluated by mature results from EORTC 22991 and RTOG 0815 trials.

Clinical trial identification

OTT 01-01

Legal entity responsible for the study

Ottawa Hospital Research Institute

Funding

None

Disclosure

All authors have declared no conflicts of interest.

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