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New treatment option for Prostate Cancer
Official title 7-Days Water-Only Fasting or Ketone Supplementation Trial in Prostate Cancer
ClinicalTrials.gov ID: NCT06826924
What this study is testing
- What it's testing
- Activating the immune system to kill cancer cells is a promising therapeutic strategy for some patients with cancer. Unfortunately, current immune-targeting treatments do not work for patients with prostate cancer.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Age ≥18 years
- Diagnosis of adenocarcinoma of the prostate
- If a soft tissue metastasis amenable to biopsy is present, then the participant must agree to biopsies.
- If the participant has local prostate cancer, then the participant must agree to prostate biopsy or radical prostatectomy on days 8, 9, or 10. -...
You likely can't join if
- ECOG Performance status ≥2
- Unintentional weight loss greater than or equal to 5% in previous 3 months
- Diabetes mellitus, defined as HbA1c ≥6.5% or use of medications for diabetes
- Active uncontrolled infection. Patients with a history of HIV/AIDS may be eligible if CD4+ T cell counts are ≥ 350 cell/ul, the patients have had no...
- Use of immunosuppressive medications including steroids
- Use of diuretics or beta blockers
See the full eligibility criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Age ≥18 years
- Diagnosis of adenocarcinoma of the prostate
- If a soft tissue metastasis amenable to biopsy is present, then the participant must agree to biopsies.
- If the participant has local prostate cancer, then the participant must agree to prostate biopsy or radical prostatectomy on days 8, 9, or 10. -. Prostate-specific antigen (PSA) is not currently declining, as determined...
- BMI between 20 and 35 kg/m2
- Prior treatment with any prostate cancer therapy is permitted if \>2 weeks from last dose. Patients are not required to have received prior treatment for prostate cancer.
- Prior treatment with steroids is permitted if \>2 weeks from last dose. Patients who cannot be weaned off steroids are not eligible.
- Acceptable liver function:
- Bilirubin \< 2.5 times institutional upper limit of normal (ULN)
- Aspartate transaminase (AST) (SGOT) and Alanine transaminase (ALT) (SGPT) \< 2.5 times ULN
- Acceptable renal function: glomerular filtration rate (GFR) of 50 mL/min/1.73 m2 or higher. GFR will be estimated by the 2021 chronic kidney disease epidemiology (CKD-EPI) creatinine equation1 using the online...
- Acceptable hematologic status:
- Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 (1.5 ×109/L)
- Platelet count ≥ 100,000 platelet/mm3 (100 ×109/L)
- Hemoglobin ≥ 8 g/dL.
- Acceptable electrolyte and acid/base status:
- Sodium 135-148 millimoles (mM)
- Potassium 3.5-5.1mM
- Carbon Dioxide 21-31mM
- Phosphorus 2.7-4.5mM
- Magnesium ≥1.6mM
- Lactate ≤2mM
- Ability to understand and willingness to sign a written informed consent document
- ECOG Performance status ≥2
- Unintentional weight loss greater than or equal to 5% in previous 3 months
- Diabetes mellitus, defined as HbA1c ≥6.5% or use of medications for diabetes
- Active uncontrolled infection. Patients with a history of HIV/AIDS may be eligible if CD4+ T cell counts are ≥ 350 cell/ul, the patients have had no opportunistic infection within the past 12 months, they have been on...
- Use of immunosuppressive medications including steroids
- Use of diuretics or beta blockers
- History of cardiac arrythmia, myocardial infarction, valvular heart disease, or pulmonary hypertension
- Abnormal screening EKG
- Daily alcohol consumption
- Any condition or mental impairment that may compromise the ability to give informed consent, patient's safety or compliance with study requirements as determined by the investigator
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.