Early Investigation of High Precision Radiotherapy Prior to Commencing Standard Radiotherapy for Prostate Cancer

NCT02004223 | Completed DMC

• 1 other identifier: 13-NSCCRO-P001
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Current standard treatment for prostate cancer involves giving patients approximately 40 doses of radiotherapy, one dose per day over an 8 week period. The purpose of this study is to assess the effects of giving two separate high doses of a special type of precision radiotherapy to the prostate and then 5 weeks (instead of 8 weeks) of standard radiotherapy. Hypothesis: It is safe to give patients an extra two doses of high-precision radiotherapy prior to commencing a shorter period of standard radiotherapy for prostate cancer.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Dose escalation; Stereotactic; SBRT; Hypofractionation

Outcome Measures

Primary Outcomes (1)

• Acute toxicity

  Portion of patients with grade 3 or greater genitourinary or gastrointestinal toxicity assessed using the Modified Radiation Therapy Oncology Group (RTOG) Toxicity Scale.

  Assessed up to 12 weeks post treatment.

Secondary Outcomes (4)

• Late toxicity

  Up to five years

• Cumulative toxicity rate:

  From the date of treatment completion assessed up to 5 years

• Biochemical failure (PSA failure)

  Up to 5 years.

• change in Quality of Life

  From baseline assessed up to 5 years.

Study Arms (1)

Dose escalation using stereotactic boost

EXPERIMENTAL

Dose level allocation - Participants will be allocated to the current dose level, or if the current dose level has been filled and acceptable toxicity has been established, they will be enrolled into the next dose level

Radiation: Dose escalation using stereotactic boost

Interventions

Dose escalation using stereotactic boost RADIATION

This is a dose escalation study. Participants will be allocated to the current dose level, or if the current dose level has been filled and acceptable toxicity has been established, they will be enrolled into the next dose level. The first dose level will be 20Gy in 2 fractions to PTV and 25Gy to Gross Target Volume (GTV) if identified. The second dose level will be 22Gy in 2 fractions to PTV and 27.5Gy to GTV if identified. The dose level will be 24 Gy in 2 fractions to PTV and 30Gy to GTV if identified. Following stereotactic boost, all participants will receive 46Gy in 23 fractions radiotherapy to the prostate / seminal vesicles +/- lymph nodes.

Dose escalation using stereotactic boost

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven prostate adenocarcinoma
• PSA obtained within three months prior to enrollment.
• International Prostate Symptom Score (I-PSS) score \<15
• No contraindication to MRI (pacemaker, severe claustrophobia)
• Patient must be able to have fiducial markers placed in the prostate (if on anticoagulants, must be cleared by LMO or cardiologist).
• ECOG performance status 0-2
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Previous pelvic radiotherapy
• Prior total prostatectomy
• Unwilling or unable to give informed consent
• Unwilling or unable to complete quality of life questionnaires.

Sponsors & Collaborators

• Royal North Shore Hospital: lead

Study Sites (1)

Northern Sydney Cancer Centre, Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

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

• Thomas N Eade, MBBS

  Royal North Shore Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Staff Specialist (Radiation Oncology)

Study Record Dates

• First Submitted: November 25, 2013
• First Posted: December 9, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: June 15, 2021

Record last verified: 2021-06

Locations

AU (1)