Quality of life after sipuleucel-t therapy: Results from a randomized, double-blind study in patients with androgen-dependent prostate cancer

Tomasz (Tom) Beer, Paul F. Schellhammer, John M. Corman, L. Michael Glodé, Simon J. Hall, James B. Whitmore, Mark W. Frohlich, David F. Penson

    Research output: Contribution to journalArticle

    10 Citations (Scopus)

    Abstract

    Objective: To collect and analyze quality-of-life (QOL) data from PROvenge Treatment and Early Cancer Treatment trial (PROTECT, NCT00779402), a phase III, randomized controlled trial of sipuleucel-T in patients with asymptomatic androgen-dependent prostate cancer. Methods: Patients experiencing prostate-specific antigen relapse after radical prostatectomy entered a 3- to 4-month run-in phase of androgen-deprivation therapy (ADT), followed by 2:1 randomization to sipuleucel-T or control. QOL was assessed throughout the run-in and 26-week post-randomization phases using the Brief Fatigue Inventory (BFI), Linear Analog Self-Assessment (LASA) scale, Global Rating of Change (GRoC) scale, and an elicited symptoms list. Results: One hundred seventy-six patients were randomized into 2 groups, the sipuleucel-T group (n = 117) or the control group (n = 59). The sample provided 80% power to detect a difference in fatigue interference score between treatment arms of 0.9 points. QOL declined predictably during ADT. At week 26, 26.2% of sipuleucel-T-treated patients and 21.6% of control-treated patients (P =.68) reported fatigue in the previous week, and the mean score for fatigue interference in the past 24 hours was 0.9 for both arms (P =.88). Results were comparable for usual fatigue (P =.91) and worst fatigue (P >.99). Mean LASA scores decreased in both groups (P =.26). The proportion of patients reporting better overall QOL on GRoC was similar (P =.62). Conclusion: There is no clinically significant negative impact on QOL after sipuleucel-T treatment compared with control after a period of ADT in patients with asymptomatic androgen-dependent prostate cancer.

    Original languageEnglish (US)
    Pages (from-to)410-415
    Number of pages6
    JournalUrology
    Volume82
    Issue number2
    DOIs
    StatePublished - Aug 2013

    Fingerprint

    Double-Blind Method
    Androgens
    Prostatic Neoplasms
    Fatigue
    Quality of Life
    Random Allocation
    Therapeutics
    Prostate-Specific Antigen
    Prostatectomy
    sipuleucel-T
    Randomized Controlled Trials
    Recurrence
    Equipment and Supplies
    Control Groups
    Neoplasms

    ASJC Scopus subject areas

    • Urology

    Cite this

    Quality of life after sipuleucel-t therapy : Results from a randomized, double-blind study in patients with androgen-dependent prostate cancer. / Beer, Tomasz (Tom); Schellhammer, Paul F.; Corman, John M.; Glodé, L. Michael; Hall, Simon J.; Whitmore, James B.; Frohlich, Mark W.; Penson, David F.

    In: Urology, Vol. 82, No. 2, 08.2013, p. 410-415.

    Research output: Contribution to journalArticle

    Beer, TT, Schellhammer, PF, Corman, JM, Glodé, LM, Hall, SJ, Whitmore, JB, Frohlich, MW & Penson, DF 2013, 'Quality of life after sipuleucel-t therapy: Results from a randomized, double-blind study in patients with androgen-dependent prostate cancer', Urology, vol. 82, no. 2, pp. 410-415. https://doi.org/10.1016/j.urology.2013.04.049
    Beer, Tomasz (Tom) ; Schellhammer, Paul F. ; Corman, John M. ; Glodé, L. Michael ; Hall, Simon J. ; Whitmore, James B. ; Frohlich, Mark W. ; Penson, David F. / Quality of life after sipuleucel-t therapy : Results from a randomized, double-blind study in patients with androgen-dependent prostate cancer. In: Urology. 2013 ; Vol. 82, No. 2. pp. 410-415.
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    abstract = "Objective: To collect and analyze quality-of-life (QOL) data from PROvenge Treatment and Early Cancer Treatment trial (PROTECT, NCT00779402), a phase III, randomized controlled trial of sipuleucel-T in patients with asymptomatic androgen-dependent prostate cancer. Methods: Patients experiencing prostate-specific antigen relapse after radical prostatectomy entered a 3- to 4-month run-in phase of androgen-deprivation therapy (ADT), followed by 2:1 randomization to sipuleucel-T or control. QOL was assessed throughout the run-in and 26-week post-randomization phases using the Brief Fatigue Inventory (BFI), Linear Analog Self-Assessment (LASA) scale, Global Rating of Change (GRoC) scale, and an elicited symptoms list. Results: One hundred seventy-six patients were randomized into 2 groups, the sipuleucel-T group (n = 117) or the control group (n = 59). The sample provided 80{\%} power to detect a difference in fatigue interference score between treatment arms of 0.9 points. QOL declined predictably during ADT. At week 26, 26.2{\%} of sipuleucel-T-treated patients and 21.6{\%} of control-treated patients (P =.68) reported fatigue in the previous week, and the mean score for fatigue interference in the past 24 hours was 0.9 for both arms (P =.88). Results were comparable for usual fatigue (P =.91) and worst fatigue (P >.99). Mean LASA scores decreased in both groups (P =.26). The proportion of patients reporting better overall QOL on GRoC was similar (P =.62). Conclusion: There is no clinically significant negative impact on QOL after sipuleucel-T treatment compared with control after a period of ADT in patients with asymptomatic androgen-dependent prostate cancer.",
    author = "Beer, {Tomasz (Tom)} and Schellhammer, {Paul F.} and Corman, {John M.} and Glod{\'e}, {L. Michael} and Hall, {Simon J.} and Whitmore, {James B.} and Frohlich, {Mark W.} and Penson, {David F.}",
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    T2 - Results from a randomized, double-blind study in patients with androgen-dependent prostate cancer

    AU - Beer, Tomasz (Tom)

    AU - Schellhammer, Paul F.

    AU - Corman, John M.

    AU - Glodé, L. Michael

    AU - Hall, Simon J.

    AU - Whitmore, James B.

    AU - Frohlich, Mark W.

    AU - Penson, David F.

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    N2 - Objective: To collect and analyze quality-of-life (QOL) data from PROvenge Treatment and Early Cancer Treatment trial (PROTECT, NCT00779402), a phase III, randomized controlled trial of sipuleucel-T in patients with asymptomatic androgen-dependent prostate cancer. Methods: Patients experiencing prostate-specific antigen relapse after radical prostatectomy entered a 3- to 4-month run-in phase of androgen-deprivation therapy (ADT), followed by 2:1 randomization to sipuleucel-T or control. QOL was assessed throughout the run-in and 26-week post-randomization phases using the Brief Fatigue Inventory (BFI), Linear Analog Self-Assessment (LASA) scale, Global Rating of Change (GRoC) scale, and an elicited symptoms list. Results: One hundred seventy-six patients were randomized into 2 groups, the sipuleucel-T group (n = 117) or the control group (n = 59). The sample provided 80% power to detect a difference in fatigue interference score between treatment arms of 0.9 points. QOL declined predictably during ADT. At week 26, 26.2% of sipuleucel-T-treated patients and 21.6% of control-treated patients (P =.68) reported fatigue in the previous week, and the mean score for fatigue interference in the past 24 hours was 0.9 for both arms (P =.88). Results were comparable for usual fatigue (P =.91) and worst fatigue (P >.99). Mean LASA scores decreased in both groups (P =.26). The proportion of patients reporting better overall QOL on GRoC was similar (P =.62). Conclusion: There is no clinically significant negative impact on QOL after sipuleucel-T treatment compared with control after a period of ADT in patients with asymptomatic androgen-dependent prostate cancer.

    AB - Objective: To collect and analyze quality-of-life (QOL) data from PROvenge Treatment and Early Cancer Treatment trial (PROTECT, NCT00779402), a phase III, randomized controlled trial of sipuleucel-T in patients with asymptomatic androgen-dependent prostate cancer. Methods: Patients experiencing prostate-specific antigen relapse after radical prostatectomy entered a 3- to 4-month run-in phase of androgen-deprivation therapy (ADT), followed by 2:1 randomization to sipuleucel-T or control. QOL was assessed throughout the run-in and 26-week post-randomization phases using the Brief Fatigue Inventory (BFI), Linear Analog Self-Assessment (LASA) scale, Global Rating of Change (GRoC) scale, and an elicited symptoms list. Results: One hundred seventy-six patients were randomized into 2 groups, the sipuleucel-T group (n = 117) or the control group (n = 59). The sample provided 80% power to detect a difference in fatigue interference score between treatment arms of 0.9 points. QOL declined predictably during ADT. At week 26, 26.2% of sipuleucel-T-treated patients and 21.6% of control-treated patients (P =.68) reported fatigue in the previous week, and the mean score for fatigue interference in the past 24 hours was 0.9 for both arms (P =.88). Results were comparable for usual fatigue (P =.91) and worst fatigue (P >.99). Mean LASA scores decreased in both groups (P =.26). The proportion of patients reporting better overall QOL on GRoC was similar (P =.62). Conclusion: There is no clinically significant negative impact on QOL after sipuleucel-T treatment compared with control after a period of ADT in patients with asymptomatic androgen-dependent prostate cancer.

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