Prostate SABR With Intra-Prostatic SABR Boost

NCT04212715 | Recruiting Phase 2

• 1 other identifier: E-19-4346
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Acute Toxicity

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

  3 month after accrual is completed

Study Arms (1)

Experimental arm

EXPERIMENTAL

SABR 35Gy/5 to prostate, up to 50Gy/5 to MR nodule, and 25Gy/5 to pelvic nodes and SVs

Radiation: Pelvic SABR with intra-prostatic SABR

Interventions

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

Experimental arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Saud University: lead

Study Sites (1)

King Saud University Medical City

Riyadh, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Yasir Alayed, MD

  King Saud Medical City

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yasir Alayed, MD

CONTACT

+966114671546; yalayed@ksu.edu.sa

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant and Assistant Professor

Study Record Dates

• First Submitted: December 26, 2019
• First Posted: December 27, 2019
• Study Start: December 26, 2019
• Primary Completion: December 1, 2021
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)