Table 7.
RCTs examining the effect of vitamin D ONS on PSA concentrations among men with PCa or increased PCa risk.
| First Author | Origin | Masking | Duration | Patients | Interventions | Results |
|---|---|---|---|---|---|---|
| Wagner [148] | CA | Double-blind | 3–8 wks | n = 65 patients with PCa (Gleason 6 or 7), before radical prostatectomy | 1. 400 IU vitamin D3 (n = 20) 2. 10,000 IU vitamin D3 (n = 22) 3. 40,000 IU vitamin D3 (n = 23) |
Serum PSA was lower in the combined higher-dose groups (10,000 and 40,000 IU) at the end of the trial. |
| Gee † [151] | US | Open-label | 28 d | n = 31 clinically organ-confined PCa and HGPIN, scheduled for RRP | 1. 10 μg vitamin D2 (n = 16) 2. Placebo (n = 15) |
PSA was significantly lower on d-21 in the intervention, but indifferent at the LOCF. The expression of PSA in adenocarcinoma did not differ between groups. |
| Attia † [149] | US | Double-blind | 17.6 mo | n = 70 Chemotherapy-naive men with metastatic AIPCa | 1. IV docetaxel (35 mg/m2 (days 1, 8, 15) + doxercalciferol ONS (10 mg, days 1–28) (n = 37) 2. IV docetaxel (35 mg/m2 (days 1, 8, 15) + placebo (n = 33) |
No difference in the PSA response rate was noted between groups. |
| Beer [150] | US | Double-blind | 6 mo | n = 250 men with progressive metastatic AIPCa and adequate organ function | 1. IV docetaxel (36 mg/m2/wk) for 3 wks of a 4-wk cycle + 45 mg calcitriol taken 1 d before docetaxel (n = 125) 2. IV docetaxel (36 mg/m2/wk) for 3 wks of a 4-wk cycle + placebo ONS taken 1 d before docetaxel (n = 125) |
PSA responses were observed in 58% of calcitriol patients and 49% of placebo patients (NS). The median duration of PSA progression-free survival was 7.6 mo in the placebo group and 7.9 mo among calcitriol-treated patients. |
| Safwat [154] | EG | Open-label | 2 yrs | n = 389 naïve BPH patients with moderate/severe symptoms | 1. Tamsulosin (n = 193) 2. Tamsulosin + vitamin D3 (n = 196) |
Patients receiving vitamin D3 had reduced PSA concentrations at the end of the treatment period (0.27 ± 0.08 ng/mL). |
| Chandler [155] | US | Double-blind | 3 mo | n = 105 Black men NOD | 1. Placebo (n = 27) 2. 1000 IU vitamin D3 (n = 21) 3. 2000 IU vitamin D3 (n = 28) 4. 4000 IU vitamin D3 (n = 29) |
No differences in free and total PSA were observed. |
| Colli [156] | IT | Double-blind | 12 wks | n = 119 patients with BPH | 1. Vitamin D3 analog (150 μg/d) (n = 57) 2. Placebo (n = 62) |
The change in PSA concentrations between groups was not significant. |
AIPCa, androgen-independent prostate cancer; BPH, benign prostatic hyperplasia; HGPIN, high grade prostatic intraepithelial neoplasia; IU, international units; IV, intravenous; LOCF, last-observation carry forward; NOD, not other defined; PCa, prostate cancer; PSA, prostate-specific antigen; RCT, randomized controlled trials; RRP, radical retropubic prostatectomy. † phase II trial.