Prostate Cancer
Conditions
Brief summary
Stereotactic Ablative Radiation (SABR/SBRT) will be prescribed to a dose of 35 Gy in 5 fractions, once weekly to prostate with a simultaneous intra-prostatic boost to the MR detected nodule up to 50Gy. The pelvic lymph nodes and seminal vesicles will also receive 25 Gy in 5 weekly fractions.
Interventions
SABR 25Gy / 5 fractions to pelvis; 35Gy / 5 fractions to prostate; up to 50Gy / 5 fractions to MR nodule
Sponsors
King Saud University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed prostate adenocarcinoma * 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
Exclusion criteria
* Prior pelvic radiotherapy * Contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease * Contraindication to prostate MRI * No 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Toxicity | 3 month after accrual is completed | To document the rate of acute urinary and bowel toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) criteria |
Countries
Saudi Arabia
Contacts
Primary ContactYasir Alayed, MD
Outcome results
None listed