NCT04212715 Prostate SABR With Intra-Prostatic SABR Boost
| NCT ID | NCT04212715 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | King Saud University |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2019-12-26 |
| Primary Completion | 2021-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2019-12-26 with a primary completion date of 2021-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Yasir Alayed, MD
PRINCIPAL INVESTIGATOR
King Saud Medical City
Frequently Asked Questions
Who can join the NCT04212715 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 99 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04212715 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04212715 currently recruiting?
Yes, NCT04212715 is actively recruiting participants. Contact the research team at yalayed@ksu.edu.sa for enrollment information.
Where is the NCT04212715 trial being conducted?
This trial is being conducted at Riyadh, Saudi Arabia.
Who is sponsoring the NCT04212715 clinical trial?
NCT04212715 is sponsored by King Saud University. The principal investigator is Yasir Alayed, MD at King Saud Medical City. The trial plans to enroll 30 participants.
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