The ELDORADO (Eligard®, Docetaxel and Radiotherapy) Study

• Status: Unknown status
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to see if sequence inversion of Intensity - modulated Radiotherapy (IMRT) for prostate cancer, can improve the safety and deliverability of concurrent docetaxel chemotherapy with long - term hormonal therapy. The hypothesis is that inverting the traditional sequence of radiotherapy can delay the time to treatment - induced bowel toxicity.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nova Scotia Cancer Centre
• Treatments: Androgens; Docetaxel; Leuprolide

Criteria

Inclusion Criteria:

• A histological diagnosis of adenocarcinoma of the prostate

• Life expectancy greater than 5 years.

• ECOG performance status < 1.

• Signed, written informed consent prior to randomization.

• Any one, or more, of the following criteria:

• TNM stage T2c, T3a or T3b

• Gleason score 8 to 10, as determined by central institutional review.

• PSA > 20 mcg/L, but < 50 mcg/L. OR Have a > 50% chance of recurrence after radical prostatectomy, as predicted by the Kattan Nomogram and

• Post - op PSA < 1.0 mcg/L.

• Must be able to start protocol treatment within 6 months from date of surgery.

• No evidence of metastasis, as determined by bone scan and Chest x-ray/CT abdomen/pelvis.

• Adequate marrow reserve and end - organ function

• Leukocytes > 3,000/mcL.

• Absolute neutrophil count > 1,500/mcL

• Platelets > 100,000/mcL

• Total bilirubin < 1.2 x upper limit of normal for the institution.

• AST(SGOT)/ALT(SGPT) greater than 1.5 X institutional upper limit of normal

• Creatinine within normal institutional limits OR

• Creatinine clearance > 60 mL/min using the Crockfort - Gault formula for patients with creatinine levels above institutional normal.

Exclusion Criteria:

• PSA > 50 µg/L.

• Previous pelvic radiotherapy

• Sensitivity to Docetaxel chemotherapy.

• Grade 2 or greater NCI CTCAE version 3.0 neuropathy.

• Prior malignancy within the last 5 years, other than prostate cancer, except:

• Patients with adequately treated non - melanoma cutaneous malignancies.

• Patients with a history of a curatively treated malignancy (including patients with superficial bladder cancer) who have not had evidence of recurrence for a minimum of 5 years.

• Patients with a history of hypersensitivity to polysorbate 80.

• Patients with a known history of viral hepatitis (B,C).