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Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 99 Men only

Stereotactic radiation therapy for high-risk prostate cancer

Official title: Prostate SABR With Intra-Prostatic SABR Boost: A Phase II Study

Run by King Saud University · NCT04212715 · Data updated 2026-11-12

This study is testing a new type of radiation therapy for men with high-risk prostate cancer to see if it can effectively treat the cancer while keeping patients safe.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 99 Years
SexMen only
Enrollment30 (estimated)
SponsorKing Saud University
Academic / other
Drugs / interventionsRadiation
Locations1 site (Riyadh)
StatusRecruiting
StartedDecember 26, 2019
Main results expectedDecember 2021
Study endsDecember 2026
Registry record updatedJanuary 2, 2020
Trial IDNCT04212715 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are men with histologically confirmed high-risk prostate adenocarcinoma.

Probably not a fit

Patients with prior pelvic radiotherapy or those with definitive extrapelvic nodal or distant metastatic disease may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of Stereotactic Ablative Radiation (SABR) for treating high-risk prostate cancer. Patients will receive a total dose of 35 Gy in 5 weekly fractions to the prostate, with an additional intra-prostatic boost of up to 50 Gy to targeted nodules detected by MRI. The pelvic lymph nodes and seminal vesicles will also be treated with 25 Gy in 5 fractions. The goal is to evaluate the effectiveness and safety of this combined radiation approach.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with high-risk prostate cancer by providing a more targeted and effective radiation therapy.

How similar studies have gone: Other studies have shown promising results with SABR approaches in prostate cancer, indicating potential for success in this trial.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • King Saud University Medical City
    Riyadh, Saudi Arabia     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Prostate Cancer 1464King Saud University 10
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.