5 Fractions of Pelvic SABR With Intra Prostatic SABR Boost: (5STAR-PC)

Sunnybrook Health Sciences Centre

Status

Active, not recruiting

Conditions

Prostate Cancer

Treatments

Radiation: Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5

Study type

Interventional

Funder types

Other

Identifiers

NCT04245670

5STAR-PC

Details and patient eligibility

About

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.

Enrollment

75 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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