Prostate SABR With Intra-Prostatic SABR Boost
ConditionProstate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-99
SponsorKing Saud University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Pelvic SABR with intra-prostatic SABR
RadiationSABR 25Gy / 5 fractions to pelvis; 35Gy / 5 fractions to prostate; up to 50Gy / 5 fractions to MR nodule
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Experimental armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Acute Toxicity
To document the rate of acute urinary and bowel toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) criteria
Time frame
3 month after accrual is completedSponsors and contacts
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Source ClinicalTrials.gov