title: The Di Bella Method (DBM) in the treatment of prostate cancer: a preliminary retrospective study of 16 patients and a review of the literature.
abstract: 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).
  
  
  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.
authors.affiliation: Di Bella Foundation, Via G. Marconi 51, Bologna 40122, Italy. posta@giuseppedibella.it.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Di Bella
authors.affiliation: Di Bella Foundation, Via G. Marconi 51, Bologna 40122, Italy.
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Mascia
authors.affiliation: Rizzoli Scientific Research and Care Institute, Via Giulio Cesare Pupill, 40136 Bologna, Italy.
authors.forename: Biagio
authors.initials: B
authors.lastname: Colori
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D002762:Cholecalciferol / Q000008:administration & dosage*; D003520:Cyclophosphamide / Q000008:administration & dosage; D018491:Dopamine Agonists / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008550:Melatonin / Q000008:administration & dosage*; D008875:Middle Aged; D010865:Pilot Projects; D011471:Prostatic Neoplasms / Q000188:drug therapy*; D012176:Retinoids / Q000008:administration & dosage*; D012189:Retrospective Studies; D013004:Somatostatin / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D018491:Dopamine Agonists; D012176:Retinoids; D002762:Cholecalciferol; D013004:Somatostatin; D003520:Cyclophosphamide; D008550:Melatonin