Prostate SABR With Intra-Prostatic SABR Boost
Recruiting · NCT04212715 · Interventional (participants receive a specific treatment) · Lead sponsor: King Saud University
View the official record on ClinicalTrials.gov →Interventions studied
Pelvic SABR with intra-prostatic SABR
What this trial is about
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.
Who can take part
Age range
18 Years to 99 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- King Saud University Medical City - Riyadh, Saudi Arabia