NCT04212715RecruitingPhase 2
Prostate SABR With Intra-Prostatic SABR Boost
Prostate SABR With Intra-Prostatic SABR Boost: A Phase II Study
Source: ClinicalTrials.gov · Last updated 2 Jan 2020 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 26 Dec 2019
- Start date
- 26 Dec 2019
- Primary completion date
- Dec 2021
- Lead sponsor
- King Saud University
- Diseases
- Prostate cancer
- NCT number
- NCT04212715
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 26 Dec 2019 to the primary completion date, Dec 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior pelvic radiotherapy
Other illness
- Contraindication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
- Definitive extrapelvic nodal or distant metastatic disease on staging investigations.
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 99 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| King Saud University Medical City Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.