Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-02-22 @ 7:03 AM
Study NCT ID:
NCT03679260
Status:
COMPLETED
Last Update Posted:
2023-03-30
First Post:
2018-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050528', 'term': 'Diet, Carbohydrate-Restricted'}, {'id': 'D064686', 'term': 'Nutritionists'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D006282', 'term': 'Health Personnel'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-28', 'studyFirstSubmitDate': '2018-09-11', 'studyFirstSubmitQcDate': '2018-09-18', 'lastUpdatePostDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean difference change in proliferative index in prostate cancer patients between carbohydrate restricted diet and non-restricted diet groups from pre-study biopsy (baseline) to 6 months.', 'timeFrame': '6 months', 'description': 'Proliferative index is measured by Ki67/apoptosis rate'}], 'secondaryOutcomes': [{'measure': 'Mean difference in weight loss before and after intervention between between carbohydrate restricted diet and non-restricted diet groups from baseline to 6 months.', 'timeFrame': '6 months'}, {'measure': 'Mean difference in absolute risk of progression to AUA intermediate risk from baseline to 6 months.', 'timeFrame': '6 months', 'description': 'AUA intermediate risk is PSA \\> 10ng/ml or grade group ≥ 2 or clinical stage ≥ T2b'}, {'measure': 'Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using EORTC-QLQ-C30.', 'timeFrame': '6 months'}, {'measure': 'Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using IPSS.', 'timeFrame': '6 months'}, {'measure': 'Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using FACT-Cog.', 'timeFrame': '6 months'}, {'measure': 'Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using PROMIS-fatigue.', 'timeFrame': '6 months'}, {'measure': 'Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using FACIT-F.', 'timeFrame': '6 months'}, {'measure': 'Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using IIEF-5.', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prostate Cancer', 'Prostate Adenocarcinoma', 'Active Surveillance', 'Diet', 'Weight Loss', 'low carb', 'Ketogenic Diet', 'Ketogenic'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This phase 2 waitlist-controlled, randomized trial is designed to compare the difference in proliferative index (Ki67) between carbohydrate restricted diet and usual care over a 6 month period in men with prostate cancer who have been placed on Active Surveillance. Eligible patients include men over 18 years old, BMI \\>25, with their most recently performed biopsy pathologically confirming prostate adenocarcinoma who have been placed on AS. Arms of the trial will be randomized 1:1 in a crossover approach, with Arm A receiving a carb restricted diet over 6 months then SOC and Arm B receiving the waitlist control arm (i.e. SOC then allowed to go on diet after 6 months). Ki67 will be performed on tissue from the most recent biopsy at the beginning of the study and again on tissue obtained in the 6 month SOC biopsy. Every patient will be on the study for 12 months, and the study will continue for approximately 3.5 years.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pathologically confirmed prostate adenocarcinoma\n* Most recent biopsy positive for prostate cancer\n* Currently on or starting active surveillance\n* Ability to read, write, and understand English\n* BMI \\>24 kg/m2\n* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.\n* Scheduled to undergo a prostate biopsy in 6 months as part of standard of care for their prostate cancer\n* Age \\> 18 years\n\nExclusion Criteria:\n\n* Already consuming a severely carbohydrate-restricted (i.e. \\<20g total carbohydrates per day) or vegetarian diet\n* Medical comorbidities that in the opinion of the investigator limits the patient's ability to complete this study\n* Anticipate needing prostate cancer therapy within the next 12 months (i.e. surgery, radiation, or hormonal therapy)\n* Loss of \\>10% of body weight within the previous 6 months\n* Currently receiving any oral hormonal therapy for prostate cancer or BPH (finasteride, dutasteride, bicalutamide)\n* If prior oral hormonal therapy use for prostate cancer or BPH (as defined above), must not have been taking at time of prior biopsy and must be off for at least 3 months prior to study enrollment (oral medications)\n* Having ever received any injection hormonal therapy or investigational vaccine for prostate cancer (LHRH agonist, LHRH antagonists, ProstVax, Provenge)\n* Current use of weight loss medications including herbal weight loss supplements or enrolled in a diet/weight loss program"}, 'identificationModule': {'nctId': 'NCT03679260', 'briefTitle': 'Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'Carbohydrate and Prostate Study 3: Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance', 'orgStudyIdInfo': {'id': 'IIT2018-06-FREEDLAND-AS3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': 'Carbohydrate restricted diet and phone counseling with dietitian. After 6 months, patients will crossover to a non-restricted diet.', 'interventionNames': ['Other: Carbohydrate restricted diet', 'Other: Non-restricted diet', 'Other: Phone counseling with dietitian']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B', 'description': 'Non-restricted diet and after 6 months, patients will crossover to a carbohydrate restricted diet and phone counseling with dietitian', 'interventionNames': ['Other: Carbohydrate restricted diet', 'Other: Non-restricted diet', 'Other: Phone counseling with dietitian']}], 'interventions': [{'name': 'Carbohydrate restricted diet', 'type': 'OTHER', 'description': '20 grams total carbs/day', 'armGroupLabels': ['Arm A', 'Arm B']}, {'name': 'Non-restricted diet', 'type': 'OTHER', 'description': 'Subject follows normal diet', 'armGroupLabels': ['Arm A', 'Arm B']}, {'name': 'Phone counseling with dietitian', 'type': 'OTHER', 'description': 'Weekly calls with dietitian', 'armGroupLabels': ['Arm A', 'Arm B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Stephen Freedland, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinai Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Center for Integrated Research in Cancer and Lifestyle; Co-Director, Cancer Genetics and Prevention Program; Professor, Surgery', 'investigatorFullName': 'Stephen Freedland', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}