Objective: To evaluate the objective clinical response and the safety of the combined administration of somatostatin, melatonin, retinoids, vitamin D3, dopamine subtype 2 receptor (D2R) agonists and low doses of cyclophosphamide, associated with androgen ablation, in patients with a histological diagnosis of prostate adenocarcinoma (Pac).
Materials and Methods: The clinical data of 30 patients with non-invasive and metastatic prostate cancer, who attended our institution over a period of more than 5 years, were retrospectively reviewed.
Results: 16 patients satisfied the evaluation criteria.
Median age: 64 years.
Disease stages: 8 patients (50%) were in Stage II. For advanced stages (Stage IV), secondary lesions were located in the bones and lymph nodes. Taken together, an overall objective response (OR) [Complete response (CR) + Partial Response (PR)] was achieved in 69% of the patients, with 88% of objective clinical benefit [CR+PR+SD]. For local Prostate Cancer group, an OR was achieved in 87.5% of patients (7 cases; 53-98; 95% CI), with CR in 62.5% (5 cases, 31-86; 95% CI). In metastatic disease, the OR was 50% (4 cases; 21-78; 95% CI), with a 20% of CR (2 cases; 7-59; 95% CI) and 75% of clinical benefit.
Conclusions: This preliminary study shows that patients with early and advanced forms of prostate cancer, not previously treated by surgery and/or chemo-radiotherapy, can achieve a more than positive clinical benefit with the protocol foreseen by the Di Bella Method. Further clinical investigations are strongly recommended.
Written by:
Di Bella G1, Mascia F2, Colori B3 Are you the author?
1Di Bella Foundation, Via Guglielmo Marconi 51 Bologna, 40122, Italy. . 2Di Bella Foundation, Via Guglielmo Marconi 51 Bologna, 40122, Italy. 3Rizzoli Scientific Research and Care Institute, Via Giulio Cesare Pupill, 40136 Bologna, Italy.
Reference: Neuro Endocrinol Lett. 2013 Nov 2;34(6):523-528. (Epub ahead of print)
PubMed Abstract
PMID: 24378460
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