Radiation Oncology/RTOG Trials/9202

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  • Title: Phase III Randomized Trial of Long-Term Adjuvant Total Androgen Suppression with ZDX vs No Subsequent Treatment Following Neoadjuvant FLUT/ZDX and Radiotherapy for Locally Advanced Carcinoma of the Prostate
  • Objectives:
    • (1) Compare locoregional control, disease-free survival, and overall survival in patients with carcinoma of the prostate who are considered at high risk of relapse and receive long-term adjuvant zoladex (ZDX) vs. no adjuvant treatment following neoadjuvant ZDX/flutamide and radiotherapy.
    • (2) Compare sexual function in patients treated with these two regimens.
  • Protocol:
    • Arm 1: AST plus RT
    • Arm 2: AST plus RT followed by 24 months AST
  • Eligibility: cT2c - T4 and PSA <150 and M0
  • Enroll Target: 1502 patients
  • Conclusion:
    • PMID 14581419 Full_Text -- Phase III trial of long-term adjuvant androgen deprivation after neoadjuvant hormonal cytoreduction and radiotherapy in locally advanced carcinoma of the prostate: the Radiation Therapy Oncology Group Protocol 92-02. (Hanks GE, JCO 2003). Conclusion:The RTOG 92-02 trial supports the addition of LT adjuvant AD to STAD with RT for T2c-4 PC. In the exploratory subset analysis of patients with Gleason scores 8 to 10, LT adjuvant AD resulted in a survival advantage.
  • Publications:
    • ASCO Abstract -- Surrogate Endpoint for Prostate Cancer-specific Survival: Validation from an Analysis of Radiation Therapy Oncology Group Protocol 92-02 (Valicenti R, ASCO 2005). Conclusion: Post-treatment PSA-DT <12 months met all of Prentice’s criteria for surrogacy. For the first time, this was accomplished for a prospectively studied patient population, and justifies strong consideration for PSA-DT< 12 months as a surrogate endpoint for prostate cancer mortality.
    • ASCO Abstract PowerPoint -- Prognostic value of abnormal p53 expression in locally advanced prostate cancer treated with androgen deprivation and radiotherapy: A study based on RTOG 9202 (Che M, ASCO Abstract 2005). Conclusion:The study confirms that abnormal p53 expression is a significant and independent adverse prognostic factor in patients with locally advanced Pca, which provides a rationale for stratifying patients according to p53 status in future prospective clinical trials.
    • PMID 15169799 -- Ki-67 staining is a strong predictor of distant metastasis and mortality for men with prostate cancer treated with radiotherapy plus androgen deprivation: Radiation Therapy Oncology Group Trial 92-02. (Pollack A, JCO 2004). Conclusion::Ki67-SI was the most significant determinant of DM and CSD and was also associated with OD. The Ki67-SI should be considered for the stratification of patients in future trials.
    • ASCO Abstract FDA_Presentation -- Can biochemical failure (ASTRO definition) be used as a surrogate endpoint for prostate cancer survival in phase III localized prostate cancer clinical trials? Analysis of RTOG protocol 92-02 (Sandler HM, ASCO Abstract 2003). Conclusion: Of the four Prentice criteria, the first three were met. Importantly, however, the fourth criterion was not satisfied -- for those who failed biochemically, the relative risk of prostate cancer related death for patients treated with LTAD is 1.5 (p=0.05) times greater than STAD, indicating that the significance of a PSA failure event is not the same for each of the protocol arms. Thus, PSA failure may not be a satisfactory surrogate marker for prostate cancer survival in randomized clinical trials when the treatments have different duration of androgen deprivation.
    • ASCO Abstract -- Preferences for short versus long - term androgen deprivation in prostate cancer survivors. (Wilke D, ASCO 2004). Conclusion: Prostate cancer patients are willing to accept decreased survival in order to avoid the quality of life consequences of long-term androgen deprivation.
    • ASTRO Abstract -- Ki-67 Staining Is a Strong Predictor of Patient Outcome for Prostate Cancer Patients Treated with Androgen Deprivation Plus Radiotherapy: An Analysis of RTOG 92-02. (Pollack A, IJRBOP 57 (2 Suppl): S200-1, 2003). Conclusion: Ki67-SI was the most significant determinant of DM and CSD, and was also associated with OD. The relationship of Ki67-SI to patient outcome is a continuous function, wherein the higher the Ki67-SI the greater the risk of an adverse result. The 7.1% cut point has been confirmed as correlating with DM and CSD, and appears to be useful in the selection of patients who will not benefit from LTAD+RT over STAD+RT. The KI67-SI should be incorporated into the stratification of patients in future trials.
    • Hanks GE, Lu JD, Machtay M, et al.: RTOG protocol 92-02: a phase III trial of the use of long term total androgen supppression following neoadjuvant hormonal cytoreduction and radiotherapy in locally advanced carcinoma of the prostate. Int J Radiat Oncol Biol Phys 48(3 suppl): A-4, 112, 2000.
    • ASCO Abstract -- RTOG Protocol 92-02: A Phase III Trial of the Use of Long Term Androgen Suppression Following Neoadjuvant Hormonal Cytoreduction and Radiotherapy in Locally Advanced Carcinoma of the Prostate. (Hanks G, ASCO Abstract 2000). Conclusion: This study supports the continued use and study of LTAD in patients with poorly differentiated or locally advanced prostate cancers.