5 Fractions of Pelvic SABR With Intra Prostatic SABR Boost:

5 Fractions of Pelvic SABR With Intra Prostatic SABR Boost:A Phase II Study (5STAR-PC)

Stereotactic Ablative Body Radiotherapy (SABR) given in 5 weekly fractions. Simultaneously treating the pelvic lymph nodes, prostate and MRI-nodule to a total dose of 25 Gy, 35 Gy and up to 50 Gy, respectively. The radiation will be given with 6-18 months of ADT.

5-fraction SABR is a feasible, well-tolerated, effective and cost effective treatment for high-intermediate and high risk prostate cancer with/without an image-guided intraprostatic boost.

Inclusion Criteria

• Histologically confirmed prostate adenocarcinoma (centrally reviewed)
• High-intermediate risk defined as two or more of: T2c, Gleason 7 OR PSA 10-20ng/ml,
• High-risk prostate cancer, defined as at least one of: T3, Gleason 8-10, OR PSA > 20 ng/mL
• Willing to give informed consent to participate in this clinical trial
• Able and willing to complete EPIC, PORPUS and EQ-5D questionnaires

Exclusion Criteria

• Prior pelvic radiotherapy
• Contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
• Anticoagulation medication (if unsafe to discontinue for fiducial insertion)
• Diagnosis of bleeding diathesis
• Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) >20
• Evidence of castrate resistance (defined as PSA < 3 ng/ml while testosterone is < 0.7nmol/l. Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression.
• Definitive extrapelvic nodal or distant metastatic disease on staging investigations.
• Hip prosthesis