Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Adenocarcinoma

Prostatic Neoplasms

Carcinosarcoma

Mixed Tumor, Mullerian

Adenoma, Pleomorphic

Neoplasms by Histologic Type

Sarcoma

Neoplasms, Connective and Soft Tissue

Malignant Mixed Mullerian Tumor

Soft Tissue Sarcoma

High PSA levels

Natalia Goldberg, MD

In our study, the investigators want to find correlation between circulating miRNAs associated with prostate cancer metastases to bones and to lymph nodes separately with results of 68Ga-PSMA ligand PET (positron emission computed) imaging.

microRNA Profiles Identification in Adeno Carcinoma Prostate Cancer

Location of metastasis by a report analyzing the pathological examination (PET-MR output).

Validation of MicroRNA pattern by using real time PCR

Assuta Medical Center

Principal Investigator

Skin and Connective Tissue Diseases

Breast Neoplasms

Endometrial Neoplasms

Neoplasms, Glandular and Epithelial

Breast Diseases

Skin Diseases

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Patients then undergo 25% caloric intake for 3-12 weeks prior to definitive cancer surgery.

Dietary Intervention

Counseling

Therapeutic

Nicole Simone, MD

The purpose of this trial is to determine that sort term calorie restriction will affect tumor biology in biopsy proven breast, endometrial or prostate cancers, which will positively impact biomarkers including miR-21, an onco-miR known to impact cancer outcomes.

PRIMARY OBJECTIVES:

1) Investigate if caloric restriction will change serum micro ribonucleic acid (RNA) 21 (miR-21) expression in patients with prostate, endometrial or breast cancer.

SECONDARY OBJECTIVES:

1. Investigate measurable changes induced by caloric restriction on both patient (host) and tumor characteristics from caloric restriction.
2. Investigate the adherence of the patient to the diet.

4) Weight, height, and body composition will be assessed via BodyMetrix. BodyMetrix uses ultrasound technology to measure subcutaneous fat.

5) Patients will have psycho-social evaluation using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) test (prostate cancer), FACT-Breast (B) test (breast cancer), or the FACT-Endometrial Cancer (En) test (endometrial cancer) and the Patient Reported Outcomes Measurement Information System (PROMIS) cancer fatigue short form at baseline, midway through diet, and at the conclusion of the diet.

6) Patient's nutritional status (Mini Nutritional Assessment \[MNA\] form) will be assessed, and their caloric needs will be calculated.

7) Local recurrence, progression free survival, distant metastases and overall survival will be assessed.

Caloric Restriction Before Surgery in Treating Patients With Endometrial, Prostate, or Breast Cancer

Caloric Restriction for Oncology Research: Pre-operative Caloric Restriction Prior to Definitive Oncologic Surgery

Will be evaluated by a two-sided paired t-test at significance level 0.05.

Will be assessed by modeling BMI as a function of time via mixed-effects regression.

Will be assessed as a function of time via mixed-effects regression.

Initial cancer biopsy specimen for genomic analysis will be comped to definitive surgical specimens.

Will be analyzed via survival methods, specifically the Kaplan-Meier method and the log-rank test. If sufficient events occur, may assess the impact of various patient and clinical/treatment variables on these outcomes via Cox proportional hazards regression. Will be assessed and compared with historic controls using the Kaplan Meier method.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
microRNA Profiles Identification in Adeno Carcinoma Prostate Cancer	NCT02964351	Prostate Carcin...	High PSA levels	18 Years -	Assuta Medical Center
Caloric Restriction Before Surgery in Treating Patients With Endometrial, Prostate, or Breast Cancer	NCT02983279	Breast Carcinom... Endometrial Car... Prostate Carcin...	Dietary Interve... Counseling Therapeutic	18 Years -	Thomas Jefferson University

Spots Global Cancer Trial Database for prostate carcinosarcoma