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Recruiting Phase 2 NCT04212715

Prostate SABR With Intra-Prostatic SABR Boost

Trial Parameters

Condition Prostate Cancer
Sponsor King Saud University
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 30
Sex MALE
Min Age 18 Years
Max Age 99 Years
Start Date 2019-12-26
Completion 2021-12
Interventions
Pelvic SABR with intra-prostatic SABR

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.

Eligibility Criteria

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.

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