RecruitingPhase 2NCT04212715
Prostate SABR With Intra-Prostatic SABR Boost
Prostate SABR With Intra-Prostatic SABR Boost: A Phase II Study
Sponsor
King Saud University
Enrollment
30 participants
Start Date
Dec 26, 2019
Study Type
INTERVENTIONAL
Conditions
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
Sex: MALEMin Age: 18 YearsMax Age: 99 Years
Inclusion Criteria3
- 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 Criteria5
- 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.
Interventions
RADIATIONPelvic SABR with intra-prostatic SABR
SABR 25Gy / 5 fractions to pelvis; 35Gy / 5 fractions to prostate; up to 50Gy / 5 fractions to MR nodule
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04212715
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