Prostate Boost Irradiation With Stereotactic Body RT (SBRT)

Official Title

A Randomized Phase II Trial Investigating Stereotactic Body RadioTherapy (SBRT) for Prostate Boost Irradiation in the Treatment of High Risk Prostate Cancer (PrCa)

Summary:

A randomized controlled open-label trial in patients with high risk prostate cancer. Eligible and consenting patients will be randomly allocated to receive stereotactic body radiation therapy (SBRT) boost to prostate or conventional radiation therapy boost to prostate in 1:1 ratio. Prostate radiation therapy boost will be administered after standard pelvic radiation therapy. Subjects will be followed for 24 months post radiation treatment for Quality of Life assessment and toxicity.

Trial Description

Primary Outcome:

• Short Term Quality of Life (QoL)

Secondary Outcome:

• Long Term Quality of Life (QoL)
• Urinary function assessment
• Late Toxicity

In this study we investigate stereotactic body radiation therapy (SBRT) as a boost radiation therapy treatment, following pelvic radiation therapy, in patients with high risk prostate cancer (PrCa) treated with Androgen Deprivation Therapy (ADT). One hundred patients with localized high risk PrCa will receive ADT for a total of 3 years. Three months after initiation of ADT all patients will receive pelvic (lymph node and prostate) treatment of 45Gy in 25 fractions (5 days per week). Then patients will be randomized to receive either The conventional radiation therapy (CRT) of 33

• 35 Gy in 16 fractions (5 days per week

• over 22 days) (comparator arm) or SBRT boost treatment of 19.5

• 21 Gy in three fractions (1 treatment per week

• over 22days) (experimental arm). SBRT boost treatment will be delivered with either cyberknife or VMAT technique.

View this trial on ClinicalTrials.gov