Phase III Study of Hypofractionated, Dose Escalation Radiotherapy for High Risk Adenocarcinoma of the Prostate, Using 3D-CRT or Intensity-Modulated Radiotherapy
1. Histologically confirmed adenocarcinoma of the prostate diagnosed within 6 months
prior to randomization
2. Patient has been classified as high risk defined clinically as: T3 or T4, Gleason
Score > 8, and/ or PSA > 20 (ng/mL or μg/L).
3. Pelvic and para-aortic lymph nodes must be negative on CT scan or MRI of the abdomen
and pelvis performed within 12 weeks prior to randomization.
4. Investigations, including chest X-ray or chest CT scan and bone scan (with
radiographs of suspicious areas) have been performed within 12 weeks prior to
randomization and are negative for metastases.
5. Patients will have had a PSA test done at the time of diagnosis. This PSA test could
be repeated within 28 days prior to randomization.
6. The patient may have received prior androgen suppression therapy provided that
androgen suppression therapy commenced no more than 28 days prior to randomization.
7. The patient must not have received any cytotoxic anticancer therapy for prostate
cancer prior to randomization.
8. ECOG performance status must be 0 or 1
9. Hematology and biochemistry: should be done within 28 days prior to randomization:
1. Hemoglobin > 100 g/L
2. Absolute Neutrophils > 1.5 x 109/L
3. Platelets > 100 x 109/L
4. AST and/or ALT < 1.5 x Upper Limit of Normal (ULN)
5. Alkaline phosphatase < 2.5 x Upper Limit of Normal (ULN)
6. Total bilirubin < ULN
7. Serum creatinine < 1.5 x ULN
10. adequate birth control measures should be used by the participant
11. Patient consent must be obtained according to local Institutional and/or University
Human Experimentation Committee requirements.
12. Patients must be accessible for treatment and follow-up.
1. Patients with a history of other malignancies, except: non-melanoma skin cancer; or
other solid tumours curatively treated with no evidence of disease for > 5 years.
2. The presence of small-cell or transitional-cell carcinoma in the biopsy specimen.
3. Patients who had previous chemotherapy for carcinoma of the prostate.
4. Patients who had prior surgical treatment for carcinoma of the prostate apart from
trans-urethral resection, including bilateral orchiectomy.
5. Patients with any contraindication to pelvic radiotherapy: including, but not limited
to, previous pelvic radiotherapy, inflammatory bowel disease or severe bladder
6. Patients with serious non malignant disease resulting in a life expectancy less than
7. Other serious illness, psychiatric or medical condition that would not permit the
patient to be managed according to the protocol
8. Known hypersensitivity to any protocol-indicated study medications.
9. Presence of bilateral hip replacement prostheses.