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Effect of Weight Loss on Prostate Cancer Pathology

17 août 2018 mis à jour par: VA Office of Research and Development
The purpose of this study is to determine if weight loss prior to radical prostatectomy effects chemical substances in the blood stream and prostate tissue that may affect prostate cancer development and progression.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

Obesity is an epidemic, a major public health concern, and is a significant risk factor for progression and mortality from prostate cancer. Prior work in the investigators' laboratory in pre-clinical prostate cancer models and in obese men found that a low fat diet, exercise, and weight loss resulted in antiproliferative and pro-apoptotic effects on prostate cancer tissue through mechanisms related to the IGF-axis. The investigators now propose to conduct a prospective, randomized clinical trial in overweight and obese men with prostate cancer undergoing radical prostatectomy to evaluate if weight loss prior to radical prostatectomy results in antiproliferative and pro-apoptotic effects in prostate cancer tissue. The investigators will accomplish this aim by enrolling overweight and obese men with prostate cancer scheduled to undergo radical prostatectomy. Following informed consent, men will be randomized to either immediate radical prostatectomy or to an 8-week weight loss intervention group that will undergo a diet and exercise weight loss program followed by radical prostatectomy. Proliferation and apoptosis of prostate cancer cells in the prostatectomy specimen will be compared between the groups and relative to the baseline prostate needle biopsy specimens. Further studies will evaluate potential serum surrogate biomarkers that the investigators developed in the investigators' laboratory (ex-vivo serum bioassays) and serum and tissue IGF-axis proteins that have previously been related to obesity, weight loss, and prostate cancer progression. The goal of the investigators' project will be to evaluate the potential anticancer effects of weight loss on prostate cancer tissue and to identify surrogate serum biomarkers that reflect antiproliferative and pro-apoptotic tissue effects and can be applied to future secondary prevention trials in overweight and obese prostate cancer survivors.

Type d'étude

Interventionnel

Inscription (Réel)

44

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • California
      • West Los Angeles, California, États-Unis, 90073
        • VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Homme

La description

Inclusion Criteria:

  • Subject is overweight or obese (BMI > 25 kg/m2)
  • Patient with pathologically confirmed adenocarcinoma of the prostate and has elected to undergo radical prostatectomy
  • Willing to delay radical prostatectomy for 5 to 8-weeks if randomized to the weight loss intervention group.
  • Able to adhere to physical activity intervention (able to walk for 30 minutes without rest)
  • Able to come to the VA for weight loss visits during the 5 to 8-wk study

Exclusion Criteria:

  • Any one of the following: Gleason grade > 4+4, PSA > 20.
  • History of ever receiving androgen deprivation therapy, antiandrogen therapy, or finasteride
  • Prior prostate radiotherapy (external beam or brachytherapy) or prior cryotherapy
  • Diagnosis of diabetes mellitus and on insulin**
  • Current use of weight loss medications or enrolled in a diet/weight loss program
  • Current use of lycopene supplements*** Significant co-morbidities (i.e. cardiac, pulmonary, liver disease, ongoing alcohol/drug abuse) Cardiac pacemaker

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Diagnostique
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Arm 1: Weight Loss
Weight Loss Group
Comportemental: Weight Loss
Subjects undergo a weight loss intervention prior to radical prostatectomy. The intervention includes weekly visits with the dietician, DEXA scanning, blood draws, and anthropometrics.
Comparateur actif: Arm 2: No Weight Loss
No Weight Loss Group
Autre: No Weight Loss Group
These subjects do not undergo a weight loss intervention prior to radical prostatectomy. This group does undergo DEXA scanning, blood draws, and anthropometrics prior to radical prostatectomy.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Apoptotic Index of the Highest Gleason Grade Malignant Epithelium in the Radical Prostatectomy Specimen Obtained After 8-weeks of the Dietary Intervention
Délai: 8 weeks
The primary objective is to compare the mean apoptotic index in the radical prostatectomy malignant epithelium between the Weight Loss Group and the Control Group-No Weight Loss. The apoptotic index will be measured in the malignant epithelium with the highest Gleason grade. TUNEL staining was used to identify these apoptotic cells and measure the apoptotic index, which is the percent of cells stained from the sample.
8 weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Proliferative Index in Prostate Cancer Epithelium Specimen
Délai: 8 weeks
The proliferative index in prostate cancer epithelium obtained from the radical prostatectomy specimen. This index was procured by staining the Ki67 protein to measure cell proliferation. (Note: Ki67 is a common indicator of cell proliferation.)
8 weeks
Change in Serum IGF-related Analytes: IGF-1
Délai: baseline and post-intervention
This outcome is the measure of the hormone insulin-like growth factor 1 at baseline vs. post-intervention. We measured and compared the concentration (ng/mL) of this hormone.
baseline and post-intervention
Change in Serum IGF-related Analytes: IGFBP-1
Délai: baseline and post-intervention
This outcome is the measure of the protein, insulin-like growth factor binding protein 1, at baseline vs. post-intervention. We measured and compared the concentration (ng/mL) of this protein.
baseline and post-intervention
Ex-vivo Mitogenic and Apoptotic Activity of Patient Sera on LNCaP Cells
Délai: baseline and post-intervention
The BRDU assay measures proliferation of cultured cells such as LNCaP. We expose the cells to the patient blood and see if it inhibits prostate cancer cell growth ex vivo. We use optical density (a measure of the amount of light able to pass through the specimen) to indicate the concentration of cell proliferation.
baseline and post-intervention
Change in Body Weight
Délai: baseline and post-intervention
This change in body weight is observed by DEXA, a scanner that measures total body composition.
baseline and post-intervention
Change in Percent Body Fat
Délai: baseline and post-intervention
This change in percent body fat is observed by DEXA, a scanner that measures total body composition.
baseline and post-intervention

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

VA Office of Research and Development

Les enquêteurs

  • Chercheur principal: William Aronson, MD, VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 janvier 2009

Achèvement primaire (Réel)

1 mars 2016

Achèvement de l'étude (Réel)

1 mars 2016

Dates d'inscription aux études

Première soumission

17 mai 2007

Première soumission répondant aux critères de contrôle qualité

18 mai 2007

Première publication (Estimation)

21 mai 2007

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

31 janvier 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 août 2018

Dernière vérification

1 août 2018

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CLIN-012-06F

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