Prostate SABR With Intra-Prostatic SABR Boost

NCT ID: NCT04212715

Last Updated: 2020-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-26

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental arm

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

Group Type EXPERIMENTAL

Pelvic SABR with intra-prostatic SABR

Intervention Type RADIATION

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

Interventions

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Pelvic SABR with intra-prostatic SABR

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

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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King Saud University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Yasir Alayed

Consultant and Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yasir Alayed, MD

Role: PRINCIPAL_INVESTIGATOR

King Saud Medical City

Locations

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King Saud University Medical City

Riyadh, , Saudi Arabia

Site Status RECRUITING

Countries

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Saudi Arabia

Central Contacts

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Yasir Alayed, MD

Role: CONTACT

+966114671546

Facility Contacts

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Yasir Alayed, MD

Role: primary

+966114671546

Other Identifiers

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E-19-4346

Identifier Type: -

Identifier Source: org_study_id

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