A pilot study to evaluate the feasibility, safety and tolerability of neoadjuvant triple therapy with zoledronic acid, docetaxel, and luteinising hormone-releasing hormone (LH-RH) analogue for men with high-risk prostate cancer to be treated by radical prostatectomy

Phase 2

• Conditions: Prostate cancer; Cancer - Prostate

• Registration Number: ACTRN12607000082404
• Lead Sponsor: rology Department The Royal Melbourne Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-01-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: 15

Inclusion Criteria

Provision of written informed consent, Prostate cancer confirmed by biopsy within 6 weeks prior to consent. At least one of the following: PSA level > 15 g/L, Gleason score > 8, Clinical stage T2b or T3 disease at study entry. >50% of positive coresConsidered suitable for radical prostatectomy

Exclusion Criteria

Evidence of metastatic diseasePrior cytotoxic chemotherapy.Prior hormone therapy.Treatment with an investigational agent in the last 4 weeks.Other co-existing malignancies or malignancies diagnosed within the last 2 years with the exception of non-melanoma skin cancer.Incomplete healing from previous surgery.Absolute neutrophil count (ANC) < 1 x 109/L or platelets < 100 x 109/L.Serum bilirubin > 1.25 times the upper limit of reference range (ULRR).Initial serum creatinine 1.5 times the ULN and/or calculated creatinine clearance (by Cockroft-Gault Formula) <60 ml/min and/or known progressive renal disease. ALT or AST > 2.5 times the ULRR.Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.Recent (within 6 weeks) or planned dental or jaw surgery (e.g.extraction, implants)In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease).Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety: haematology and biochemistry evaluation.[Weekly whilst receiving therapy, then 3/12 and 24/12 following radical prostatectomy.];Tolerability: assessment of adverse events.[Weekly during therapy, then 3/12 and 24/12 following radical prostatectomy.]

Secondary Outcome Measures

Name	Time	Method
pathological response[histopathology from radical prostatectomy];Prostatic Specific Antigen (PSA) measurement[post radical prostatectomy, measured at 3/12 and 24/12 post surgery.]