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.
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Authors | Tomasz M Beer, Paul F Schellhammer, John M Corman, L Michael Glodé, Simon J Hall, James B Whitmore, Mark W Frohlich, David F Penson |
Journal | Urology
(Urology)
Vol. 82
Issue 2
Pg. 410-5
(Aug 2013)
ISSN: 1527-9995 [Electronic] United States |
PMID | 23896100
(Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2013 Elsevier Inc. All rights reserved. |
Chemical References |
- Androgen Antagonists
- Cancer Vaccines
- Tissue Extracts
- Gonadotropin-Releasing Hormone
- sipuleucel-T
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Topics |
- Aged
- Androgen Antagonists
(administration & dosage, adverse effects)
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects)
- Cancer Vaccines
(administration & dosage)
- Double-Blind Method
- Fatigue
(chemically induced)
- Gonadotropin-Releasing Hormone
(administration & dosage, adverse effects, analogs & derivatives)
- Hot Flashes
(chemically induced)
- Humans
- Male
- Middle Aged
- Prostatic Neoplasms
(complications, drug therapy)
- Quality of Life
- Sexual Dysfunction, Physiological
(chemically induced)
- Surveys and Questionnaires
- Sweating
(drug effects)
- Tissue Extracts
(administration & dosage)
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