Tests radiation therapy for prostate cancer with a targeted boost to a visible nodule
Tests high-dose radiation to the prostate and pelvic lymph nodes in men with prostate cancer.
Key facts
- Who runs it
- King Saud University
- Where
- Riyadh, Saudi ArabiaSee the site
- Trial code
- Registry title
- Prostate SABR With Intra-Prostatic SABR Boost
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 30 people, planned
- Started
- 26 Dec 2019
- Expected to end
- Dec 2026
- Type of study
- Interventional
- Treatments tested
- Pelvic SABR with intra-prostatic SABR
- Record updated
- 2 January 2020
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with high-risk prostate cancer, confirmed by a tissue sample, who can have radiation treatment to the prostate.
- Age
- 18 Years to 99 Years
- Sex
- Men only
- Disease stage
- High-risk prostate cancer: at least one of T3, Gleason 8-10, or PSA above 20 ng/mL. Prostate adenocarcinoma confirmed by a tissue sample.
- Earlier treatment
- No earlier radiotherapy to the pelvis.
Main reasons for not taking part
- Earlier radiotherapy to the pelvis
- A medical reason against radical prostate radiotherapy, for example connective tissue disease or inflammatory bowel disease
- A medical reason against a prostate MRI scan
- Cancer spread to lymph nodes outside the pelvis or to distant organs
- Hormone therapy started because the PSA was rising
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- Prior pelvic radiotherapy
- Contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
- Definitive extrapelvic nodal or distant metastatic disease on staging investigations
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 99 years old?
Where in Saudi Arabia
- King Saud University Medical CityRiyadh, Saudi ArabiaContact: Yasir Alayed, MDTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- Experimental armTreatment being tested
SABR 35Gy/5 to prostate, up to 50Gy/5 to MR nodule, and 25Gy/5 to pelvic nodes and SVs
Treatment: Pelvic SABR with intra-prostatic SABR
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Prostate SABR With Intra-Prostatic SABR Boost: A Phase II Study
- Plain-language title
- Tests radiation therapy for prostate cancer with a targeted boost to a visible noduleGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT04212715, who can take part
- Record updated
- 2 January 2020