Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04212715

Prostate SABR With Intra-Prostatic SABR Boost

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–99 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

King Saud University Medical City

Riyadh, Saudi Arabia

Location status: Recruiting

Location contact

Yasir Alayed, MD

CONTACT

[email protected]

+966114671546

Yasir Alayed, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pelvic SABR with intra-prostatic SABR

Radiation

SABR 25Gy / 5 fractions to pelvis; 35Gy / 5 fractions to prostate; up to 50Gy / 5 fractions to MR nodule

Primary outcomes

  1. Acute Toxicity

    Time frame: 3 month after accrual is completed

    To document the rate of acute urinary and bowel toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) criteria

Study contacts

Contact information is provided by the study sponsor or research team.

Yasir Alayed, MD

CONTACT

[email protected]

+966114671546

Sponsors and collaborators

Lead sponsor

King Saud University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2026
First posted
Dec 27, 2019
Registry last updated
Jan 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.