High-Dose Vitamin D for Prostate Cancer Treatment
Vitamin D for Prostate Endocrine Therapy
Recruiting
Phase 3
Interventional Study
Stage I Prostate Cancer AJCC v8
Stage II Prostate Cancer AJCC v8
Stage III Prostate Cancer AJCC v8
Stage IVA Prostate Cancer AJCC v8
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 50 and older
- Sex
- Male
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Supportive Care
- Participants needed
- 240 (estimated)
- Sponsor
- University of Rochester · Other
Who this trial is looking for
This trial is looking for men with prostate cancer who are starting hormone therapy. Participants will receive high-dose vitamin D to see if it helps protect their bones and reduces fatigue.
Are You a Good Fit for This Trial?
You may be able to join if
- I have been diagnosed with Stage I-IV prostate cancer without bone spread.
- I am 50 years old or older.
- I am starting hormone therapy or have started it in the last 6 months.
- I have a vitamin D level between 10 and 32 ng/ml.
- I have a calcium level of 10.5 mg/dl or lower.
- I have normal kidney function.
- I can take pills and capsules.
- I can read and speak English.
You may not be able to join if
- I have used bone-modifying medications for more than 3 months.
- I have stage IV chronic kidney disease.
- I have high calcium levels over 11.5 mg/dl.
- I have a history of high calcium levels or vitamin D sensitivity.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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About This Trial
This phase III trial tests whether high-dose vitamin D works in treating androgen-deprivation therapy (ADT)-induced bone loss in patients with prostate cancer who are undergoing androgen-deprivation therapy. Vitamins are substances that the body needs to grow and develop normally. Vitamin D helps the body absorb calcium. Calcium is one of the main building blocks of bone. A lack of vitamin D can l…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Be diagnosed with Stage I-IV prostate cancer without metastases to bone (lymph node involvement and prior diagnosis of a primary cancer is allowed)
* Be age 50 years or older
* Be starting ADT or have received their first ADT treatment in the past 6 months, with a total of at …
Contacts
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