Prostate Adenocarcinoma
Conditions
Keywords
Fasting
Brief summary
This is a Phase 2, randomized two-armed, multi-site study of 138 patients with metastatic castrate sensitive prostate adenocarcinoma. Patients will be randomized 1:1 to receive the fasting mimicking diet, or usual diet. All patients will receive standard of care treatment for their prostate cancer. The fasting mimicking diet will be consumed for 5 days per month for a total of 6 months and will be monitored by trained research dietitians. This study aims to examine the effects of a fasting mimicking diet (5 days per month eating L-Nutra products only for 6 months) vs. usual diet on response to cancer treatment of metastatic castrate sensitive prostate adenocarcinoma.
Interventions
BEHAVIORALFasting Mimicking Diet (FMD)
Consume the FMD (Xentigen, L-Nutra, Los Angeles, CA) for 5 days every monthly cycle for 6 cycles total in 6 months.
BEHAVIORALStandard Anti-Cancer Diet
Will receive standard of care diet and exercise recommendations from the study dietitian. The diet advice will be consistent with the American Cancer Society for cancer survivors and exercise recommendation of a goal of 150 minutes/week of cardiovascular exercise and weight resistance training at least twice a week.
Sponsors
National Cancer Institute (NCI)
Stephen Freedland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* Metastatic castrate sensitive prostate adenocarcinoma (Adenocarcinoma prostate histologically confirmed by biopsy AND Metastatic disease confirmed biopsy, or MRI scan) * Men receiving or planning to start first-line intensified ADT (within 30 days of registration) with abiraterone, apalutamide, enzalutamide, or darolutamide with or without current or prior chemotherapy * Reads, writes, and understands English or Spanish and has telephone access for remote contact with the study dietitian. * Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Exclusion criteria
* Allergies to any ingredients listed on the Xentigen Ingredient List * Men with diabetes who are not on stable doses of antihyperglycemic medication for at least 6 months and without physician consent that they may safely hold antihyperglycemic medication during the 5 days of FMD * Regularly practicing a fasting diet that in the opinion of the study physician would impact study participation * Significant co-morbidities (i.e., cardiac, pulmonary, liver disease, ongoing alcohol/drug abuse) that in the opinion of the study physician would preclude enrollment in this study. * Body Mass Index (BMI) \<20kg/m2 * Men actively trying to lose weight OR on weight loss medications (including but not limited to Contrave, Saxenda, Xenical) or planning to receive weight loss surgery in the next six months * Self-reported weight loss ≥ 10% in the last 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response to cancer treatment | 6 Month visit | Will be measured by the proportion of patients who achieved PSA nadir ≤0.2 ng/dL at any time point within the 6-month study and absolute PSA nadir. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Castration resistance 2 | 6 Month visit | will be measured by PSA levels (ng/mL) |
| Metabolic Toxicity 1 | Change from Baseline to 6 Month visit | Will be measured by the changes in HbA1c |
| Metabolic Toxicity 2 | Change from Baseline to 6 Month visit | Will be measured by the changes in waist circumference |
| Castration resistance 1 | 6 Month visit | will be measured by Testosterone (ng/dl) |
| Metabolic Toxicity 4 | Change from Baseline to 6 Month visit | Will be measured by the changes in body weight |
| Self-reported overall well-being | Change from Baseline to 6 Month visit | will be measured in changes in the scores calculated from the Medical Outcomes Study Short Form Health Survey (SF-12) questionnaire. Scores can range from 12-56 with a higher score indicating a better outcome. |
| Self-reported energy levels | Change from Baseline to 6 Month visit | will be measured in changes in the scores calculated from the Godin leisure-time physical activity questionnaire. Scores can range from 0 and above, with a higher score indicating a better physical activity outcome. |
| Metabolic Toxicity 3 | Change from Baseline to 6 Month visit | Will be measured by the changes in fat mass (assessed via bioelectrical expedience) |
Countries
United States
Contacts
Primary ContactClinical Trial Recruitment Navigator
Backup ContactStephen Freedland, MD
Outcome results
None listed