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

NCT02004223 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2021-06-15

No results posted yet for this study

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

Interventions

RADIATION

Dose escalation using stereotactic boost

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.

Sponsors & Collaborators

  • Royal North Shore Hospital

    lead OTHER

Principal Investigators

  • Thomas N Eade, MBBS · Royal North Shore Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Australia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02004223 on ClinicalTrials.gov