Trial of Hypofractionated IMRT Boost Versus Conventional IMRT Boost for Localized High Risk Prostate Cancer

Randomized Trial of Concomitant Hypofractionated IMRT Boost Versus Conventional Fractionated IMRT Boost for Localized High Risk Prostate Cancer

Hypofractionation: 48 Gy in 25 fractions to pelvic lymph nodes while the prostate receives 68 Gy in 25 fractions concomitantly.

Standard Fractionation: pelvic lymph nodes and prostate will initially be treated to 46 Gy in 23 fractions, followed by a subsequent boost to the prostate to a total dose of 78 Gy over 39 fractions.

Half the participants will receive using a one phase IMRT plan, the pelvic lymph nodes will be treated to a dose of 48 Gy in 25 fractions, while the prostate will be treated to a dose of 68 Gy in 25 fractions concomitantly (simulataneous integrated boost).

The other half of the participants will receive Standard fractionation using 2 sequential IMRT plans, the pelvic lymph nodes and prostate will initially be treated to 46 Gy in 23 fractions, followed by a subsequent boost to the prostate to a total dose of 78 Gy.

Inclusion Criteria:

• Written informed consent obtained.
• Histologically confirmed diagnosis of adenocarcinoma of the prostate.
• Clinical stage T1-2 N0 M0, Gleason Score ≤ 7, PSA 20 - 100
• T1-2 N0 M0, Gleason Score 8 - 10, PSA ≤ 100
• T3 N0 M0, any Gleason Score, PSA ≤ 100

Exclusion Criteria:

• Patients with unilateral or bilateral hip replacement.
• Patients with active collagen vascular disease.
• Patients with active inflammatory bowel disease.
• Patients with previous radiotherapy to the pelvis.
• Patients with ataxia telangiectasia.
• Patients with nodal or distant metastases