NCT02125175

Brief Summary

High dose radiotherapy is a very effective treatment for prostate cancer. However, there is an increased risk of side effects compared to lower dose radiotherapy. This study will investigate the use of dose painting radiotherapy. Dose painting radiotherapy administers a high dose of radiotherapy to areas of cancer inside the prostate and a lower (standard) dose to the rest of the prostate. This may improve control of the cancer without increasing the side effects. The radiotherapy is given in 20 doses, called fractions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 29, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

October 29, 2019

Status Verified

May 1, 2019

Enrollment Period

4.7 years

First QC Date

April 17, 2014

Last Update Submit

October 27, 2019

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Acute bladder and bowel toxicity (NCI CTCAE v 4.0 and RTOG) at 18 weeks after the commencement of radiotherapy treatment

    18 weeks

Secondary Outcomes (2)

  • The success rate of producing dose painted IMRT plans which fulfill the dose-volume constraints as specified for the prostate and for the normal tissues

    3 years

  • Late bladder and bowel toxicity (NCI CTCAE v4) at 2 years

    2 Years

Study Arms (1)

Hypofractionated IMRT boost Radiotherapy

EXPERIMENTAL
Radiation: Hypofractionated IMRT boost Radiotherapy

Interventions

Hypofractionated IMRT boost RadiotherapyRADIATION
Hypofractionated IMRT boost Radiotherapy

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed adenocarcinoma of the prostate
  • NCCN intermediate/high risk disease and estimated risk of lymph node involvement 15 - 40%\*
  • MRI stage T2a-T4 N0M0
  • Age 18-80 years
  • Normal blood count (Hb \>11g/dl, WBC \> 4000/mm3, platelets \>100,000/mm3)
  • WHO performance status 0 or 1
  • Fully informed written consent
  • Risk of pelvic lymph node involvement = (Gleason score - 6) x 10 + 2/3 PSA

You may not qualify if:

  • Prior radiotherapy to the prostate or pelvis
  • Prior hormone therapy or radical prostatectomy
  • Total hip replacement
  • Clinically significant inflammatory bowel disease
  • Contraindication to have diagnostic MRI scans
  • Unable to have a general anaesthetic
  • Anti-coagulant therapy which cannot be temporarily stopped

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Clatterbridge Cancer Centre NHS Foundation Trust

Bebington, Wirral, CH63 4JY, United Kingdom

Location

Related Publications (2)

  • Chatterjee R, Chan J, Mayles H, Cicconi S, Syndikus I. Long-term Results of Hypofractionated Radiotherapy With Intra-prostatic Boosts in Men With Intermediate- and High-risk Prostate Cancer: A Phase II Trial. Clin Oncol (R Coll Radiol). 2024 Dec;36(12):e473-e482. doi: 10.1016/j.clon.2024.08.011. Epub 2024 Aug 22.

    PMID: 39242247DERIVED

  • Onjukka E, Uzan J, Baker C, Howard L, Nahum A, Syndikus I. Twenty Fraction Prostate Radiotherapy with Intra-prostatic Boost: Results of a Pilot Study. Clin Oncol (R Coll Radiol). 2017 Jan;29(1):6-14. doi: 10.1016/j.clon.2016.09.009. Epub 2016 Sep 29.

    PMID: 27692920DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Isabel Syndikus, MD

    The Clatterbridge Cancer Centre NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2014

First Posted

April 29, 2014

Study Start

January 1, 2014

Primary Completion

September 1, 2018

Study Completion

September 1, 2019

Last Updated

October 29, 2019

Record last verified: 2019-05

Locations

GB(1)