Phase I-II prospective dose-escalating trial of lycopene in patients with biochemical relapse of prostate cancer after definitive local therapy

Peter E. Clark, M. Craig Hall, Lester S. Borden, Antonius A. Miller, Jennifer Hu, W. Robert Lee, Diana Stindt, Ralph D'Agostino, James Lovato, Michelle Harmon, Frank M. Torti

Research output: Contribution to journalArticle

57 Citations (Scopus)

Abstract

Objectives: To report a prospective trial of lycopene supplementation in biochemically relapsed prostate cancer. Methods: A total of 36 men with biochemically relapsed prostate cancer were enrolled in a dose-escalating, Phase I-II trial of lycopene supplementation. Six consecutive cohorts of 6 patients each received daily supplementation with 15, 30, 45, 60, 90, and 120 mg/day for 1 year. The serum levels of prostate-specific antigen (PSA) and plasma levels of lycopene were measured at baseline and every 3 months. The primary endpoints were PSA response (defined as a 50% decrease in serum PSA from baseline), pharmacokinetics, and the toxicity/tolerability of this regimen. Results: A total of 36 patients were enrolled. The median age was 74 years (range 56 to 83), with a median serum PSA at entry of 4.4 ng/mL (range 0.8 to 24.9). No serum PSA responses were observed, and 37% of patients had PSA progression. The median time to progression was not reached. Toxicity was mild, with 1 patient discontinuing therapy because of diarrhea. Significant elevations of plasma lycopene were noted at 3 months and then appeared to plateau for all six dose levels. The plasma levels for doses between 15 and 90 mg/day were similar, with additional elevation only at 120 mg/day. Conclusions: Lycopene supplementation in men with biochemically relapsed prostate cancer is safe and well tolerated. The plasma levels of lycopene were similar for a wide dose range (15 to 90 mg/day) and plateaued by 3 months. Lycopene supplementation at the doses used in this study did not result in any discernible response in serum PSA.

Original languageEnglish
Pages (from-to)1257-1261
Number of pages5
JournalUrology
Volume67
Issue number6
DOIs
StatePublished - Jun 1 2006
Externally publishedYes

Fingerprint

Prostate-Specific Antigen
Prostatic Neoplasms
Recurrence
Serum
Therapeutics
lycopene
Diarrhea
Pharmacokinetics

ASJC Scopus subject areas

  • Urology

Cite this

Phase I-II prospective dose-escalating trial of lycopene in patients with biochemical relapse of prostate cancer after definitive local therapy. / Clark, Peter E.; Hall, M. Craig; Borden, Lester S.; Miller, Antonius A.; Hu, Jennifer; Lee, W. Robert; Stindt, Diana; D'Agostino, Ralph; Lovato, James; Harmon, Michelle; Torti, Frank M.

In: Urology, Vol. 67, No. 6, 01.06.2006, p. 1257-1261.

Research output: Contribution to journalArticle

Clark, PE, Hall, MC, Borden, LS, Miller, AA, Hu, J, Lee, WR, Stindt, D, D'Agostino, R, Lovato, J, Harmon, M & Torti, FM 2006, 'Phase I-II prospective dose-escalating trial of lycopene in patients with biochemical relapse of prostate cancer after definitive local therapy', Urology, vol. 67, no. 6, pp. 1257-1261. https://doi.org/10.1016/j.urology.2005.12.035
Clark, Peter E. ; Hall, M. Craig ; Borden, Lester S. ; Miller, Antonius A. ; Hu, Jennifer ; Lee, W. Robert ; Stindt, Diana ; D'Agostino, Ralph ; Lovato, James ; Harmon, Michelle ; Torti, Frank M. / Phase I-II prospective dose-escalating trial of lycopene in patients with biochemical relapse of prostate cancer after definitive local therapy. In: Urology. 2006 ; Vol. 67, No. 6. pp. 1257-1261.
@article{b2b538831e674c22b815e7c4448fe6b1,
title = "Phase I-II prospective dose-escalating trial of lycopene in patients with biochemical relapse of prostate cancer after definitive local therapy",
abstract = "Objectives: To report a prospective trial of lycopene supplementation in biochemically relapsed prostate cancer. Methods: A total of 36 men with biochemically relapsed prostate cancer were enrolled in a dose-escalating, Phase I-II trial of lycopene supplementation. Six consecutive cohorts of 6 patients each received daily supplementation with 15, 30, 45, 60, 90, and 120 mg/day for 1 year. The serum levels of prostate-specific antigen (PSA) and plasma levels of lycopene were measured at baseline and every 3 months. The primary endpoints were PSA response (defined as a 50{\%} decrease in serum PSA from baseline), pharmacokinetics, and the toxicity/tolerability of this regimen. Results: A total of 36 patients were enrolled. The median age was 74 years (range 56 to 83), with a median serum PSA at entry of 4.4 ng/mL (range 0.8 to 24.9). No serum PSA responses were observed, and 37{\%} of patients had PSA progression. The median time to progression was not reached. Toxicity was mild, with 1 patient discontinuing therapy because of diarrhea. Significant elevations of plasma lycopene were noted at 3 months and then appeared to plateau for all six dose levels. The plasma levels for doses between 15 and 90 mg/day were similar, with additional elevation only at 120 mg/day. Conclusions: Lycopene supplementation in men with biochemically relapsed prostate cancer is safe and well tolerated. The plasma levels of lycopene were similar for a wide dose range (15 to 90 mg/day) and plateaued by 3 months. Lycopene supplementation at the doses used in this study did not result in any discernible response in serum PSA.",
author = "Clark, {Peter E.} and Hall, {M. Craig} and Borden, {Lester S.} and Miller, {Antonius A.} and Jennifer Hu and Lee, {W. Robert} and Diana Stindt and Ralph D'Agostino and James Lovato and Michelle Harmon and Torti, {Frank M.}",
year = "2006",
month = "6",
day = "1",
doi = "10.1016/j.urology.2005.12.035",
language = "English",
volume = "67",
pages = "1257--1261",
journal = "Urology",
issn = "0090-4295",
publisher = "Elsevier Inc.",
number = "6",

}

TY - JOUR

T1 - Phase I-II prospective dose-escalating trial of lycopene in patients with biochemical relapse of prostate cancer after definitive local therapy

AU - Clark, Peter E.

AU - Hall, M. Craig

AU - Borden, Lester S.

AU - Miller, Antonius A.

AU - Hu, Jennifer

AU - Lee, W. Robert

AU - Stindt, Diana

AU - D'Agostino, Ralph

AU - Lovato, James

AU - Harmon, Michelle

AU - Torti, Frank M.

PY - 2006/6/1

Y1 - 2006/6/1

N2 - Objectives: To report a prospective trial of lycopene supplementation in biochemically relapsed prostate cancer. Methods: A total of 36 men with biochemically relapsed prostate cancer were enrolled in a dose-escalating, Phase I-II trial of lycopene supplementation. Six consecutive cohorts of 6 patients each received daily supplementation with 15, 30, 45, 60, 90, and 120 mg/day for 1 year. The serum levels of prostate-specific antigen (PSA) and plasma levels of lycopene were measured at baseline and every 3 months. The primary endpoints were PSA response (defined as a 50% decrease in serum PSA from baseline), pharmacokinetics, and the toxicity/tolerability of this regimen. Results: A total of 36 patients were enrolled. The median age was 74 years (range 56 to 83), with a median serum PSA at entry of 4.4 ng/mL (range 0.8 to 24.9). No serum PSA responses were observed, and 37% of patients had PSA progression. The median time to progression was not reached. Toxicity was mild, with 1 patient discontinuing therapy because of diarrhea. Significant elevations of plasma lycopene were noted at 3 months and then appeared to plateau for all six dose levels. The plasma levels for doses between 15 and 90 mg/day were similar, with additional elevation only at 120 mg/day. Conclusions: Lycopene supplementation in men with biochemically relapsed prostate cancer is safe and well tolerated. The plasma levels of lycopene were similar for a wide dose range (15 to 90 mg/day) and plateaued by 3 months. Lycopene supplementation at the doses used in this study did not result in any discernible response in serum PSA.

AB - Objectives: To report a prospective trial of lycopene supplementation in biochemically relapsed prostate cancer. Methods: A total of 36 men with biochemically relapsed prostate cancer were enrolled in a dose-escalating, Phase I-II trial of lycopene supplementation. Six consecutive cohorts of 6 patients each received daily supplementation with 15, 30, 45, 60, 90, and 120 mg/day for 1 year. The serum levels of prostate-specific antigen (PSA) and plasma levels of lycopene were measured at baseline and every 3 months. The primary endpoints were PSA response (defined as a 50% decrease in serum PSA from baseline), pharmacokinetics, and the toxicity/tolerability of this regimen. Results: A total of 36 patients were enrolled. The median age was 74 years (range 56 to 83), with a median serum PSA at entry of 4.4 ng/mL (range 0.8 to 24.9). No serum PSA responses were observed, and 37% of patients had PSA progression. The median time to progression was not reached. Toxicity was mild, with 1 patient discontinuing therapy because of diarrhea. Significant elevations of plasma lycopene were noted at 3 months and then appeared to plateau for all six dose levels. The plasma levels for doses between 15 and 90 mg/day were similar, with additional elevation only at 120 mg/day. Conclusions: Lycopene supplementation in men with biochemically relapsed prostate cancer is safe and well tolerated. The plasma levels of lycopene were similar for a wide dose range (15 to 90 mg/day) and plateaued by 3 months. Lycopene supplementation at the doses used in this study did not result in any discernible response in serum PSA.

UR - http://www.scopus.com/inward/record.url?scp=33744551103&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=33744551103&partnerID=8YFLogxK

U2 - 10.1016/j.urology.2005.12.035

DO - 10.1016/j.urology.2005.12.035

M3 - Article

C2 - 16765186

AN - SCOPUS:33744551103

VL - 67

SP - 1257

EP - 1261

JO - Urology

JF - Urology

SN - 0090-4295

IS - 6

ER -