title: A randomized, double-blind, placebo-controlled study of the effects of pomegranate extract on rising PSA levels in men following primary therapy for prostate cancer.
abstract: BACKGROUND
  The primary objective of this study was to compare the effects of pomegranate juice on PSA doubling times (PSADT) in subjects with rising PSA levels after primary therapy for prostate cancer.
  
  
  METHODS
  Double-blind, placebo-controlled multi-institutional study, evaluated the effects of pomegranate liquid extract on serum PSA levels. The primary end point of this study was change in serum PSADT. Additional secondary and exploratory objectives were to evaluate the safety of pomegranate juice and to determine the interaction of manganese superoxide dismutase (MnSOD) AA genotype and pomegranate treatment on PSADT.
  
  
  RESULTS
  One-hundred eighty-three eligible subjects were randomly assigned to the active and placebo groups with a ratio of 2:1 (extract N=102; placebo N=64; juice N=17). The majority of adverse events were of moderate or mild grade. Median PSADT increased from 11.1 months at baseline to 15.6 months in the placebo group (P<0.001) compared with an increase from 12.9 months at baseline to 14.5 months in the extract group (P=0.13) and an increase from 12.7 at baseline to 20.3 in the juice group (P=0.004). However, none of these changes were statistically significant between the three groups (P>0.05). Placebo AA patients experienced a 1.8 month change in median PSADT from 10.9 months at baseline to 12.7 months (P=0.22), while extract patients experienced a 12 month change in median PSADT from 13.6 at baseline to 25.6 months (P=0.03).
  
  
  CONCLUSIONS
  Compared with placebo, pomegranate extract did not significantly prolong PSADT in prostate cancer patients with rising PSA after primary therapy. A significant prolongation in PSADT was observed in both the treatment and placebo arms. Men with the MnSOD AA genotype may represent a group that is more sensitive to the antiproliferative effects of pomegranate on PSADT; however, this finding requires prospective hypothesis testing and validation.
authors.affiliation: Department of Urology, Institute of Urologic Oncology, David Geffen School of Medicine, University of California-Los Angeles, Los Angeles, CA, USA.
authors.forename: A J
authors.initials: AJ
authors.lastname: Pantuck
authors.affiliation: The University of Texas, MD Anderson Cancer Center, Houston, TX, USA.
authors.forename: C A
authors.initials: CA
authors.lastname: Pettaway
authors.affiliation: Cleveland Clinic Foundation, Cleveland, OH, USA.
authors.forename: R
authors.initials: R
authors.lastname: Dreicer
authors.affiliation: Virginia Mason Medical Center, Seattle, WA, USA.
authors.forename: J
authors.initials: J
authors.lastname: Corman
authors.affiliation: Winthrop University Hospital, Garden City, NY, USA.
authors.forename: A
authors.initials: A
authors.lastname: Katz
authors.affiliation: Winthrop University Hospital, Garden City, NY, USA.
authors.forename: A
authors.initials: A
authors.lastname: Ho
authors.affiliation: 1] Department of Urology, Institute of Urologic Oncology, David Geffen School of Medicine, University of California-Los Angeles, Los Angeles, CA, USA [2] VA Medical Center Greater Los Angeles Healthcare System, Los Angeles, CA, USA.
authors.forename: W
authors.initials: W
authors.lastname: Aronson
authors.affiliation: Alaska Clinical Research Center, Anchorage, AL, USA.
authors.forename: W
authors.initials: W
authors.lastname: Clark
authors.affiliation: Five Valleys Urology, Missoula, MT, USA.
authors.forename: G
authors.initials: G
authors.lastname: Simmons
authors.affiliation: 1] Department of Urology, Institute of Urologic Oncology, David Geffen School of Medicine, University of California-Los Angeles, Los Angeles, CA, USA [2] Department of Medicine and Clinical Nutrition, David Geffen School of Medicine, University of California-Los Angeles, Los Angeles, CA, USA.
authors.forename: D
authors.initials: D
authors.lastname: Heber
mesh_terms: D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D018450:Disease Progression; D006801:Humans; D029561:Lythraceae / Q000737:chemistry*; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D060787:Neoplasm Grading; D009367:Neoplasm Staging; D010936:Plant Extracts / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D020641:Polymorphism, Single Nucleotide; D017430:Prostate-Specific Antigen / Q000097:blood*; D011471:Prostatic Neoplasms / Q000097:blood* / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D013482:Superoxide Dismutase / Q000235:genetics; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D010936:Plant Extracts; D013482:Superoxide Dismutase; D017430:Prostate-Specific Antigen