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Timing of HDR With EBRT in Localised Prostate Cancer,Toxicity and Quality of Life Assessment

NCT02618161 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-12-22

No results posted yet for this study

Summary

TITLE Timing of HDR brachytherapy with EBRT in intermediate and high risk localised Prostate CAncer patients and its effects on Toxicity and Quality of life - randomised feasibility trial.

SHORT TITLE THEPCA trial Protocol Version Number and Date Version 2.1, dated 16 DEC 2014 Study Duration Recruitment Duration 18-24 months

Study Centre Southend University Hospital NHS Foundation Trust

Objectives Assessment of acute toxicities: Genitourinary, gastrointestinal and sexual dysfunction at various time points.

Number of Participants 50 participants

Main Inclusion Criteria

* Patient age \>18 years
* Histologically diagnosed Prostate cancer, stages T1b-T3bN0M0
* Any Gleason score
* Any PSA level
* Patient able to consent and fill in the questionnaires Exclusion Criteria - Previous TURP/HoLEP Laser Prostatectomy
* Any Metastatic Disease
* IPSS\>20
* Pubic arch interference
* Lithotomy position or anaesthesia not possible
* Rectal fistula
* Prior pelvic radiotherapy Statistical Methodology and Analysis Percentages of adverse events will be compared using Fisher's Exact Test. Toxicity score means will be compared using two-sample permutation t-tests, and PSA relapse-free survival will be estimated using Kaplan-Meier and compared using log-rank tests.

Conditions

Interventions

RADIATION

HDR Brachytherapy

HDR Brachytherapy, a single dose of 15 Gy delivered to prostate

RADIATION

External beam Radiotherapy

External beam Radiotherapy, a dose of 46 Gy in 23 fractions delivered to prostate

Sponsors & Collaborators

  • Mid and South Essex NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Imtiaz Ahmed, MRCP FRCR · Southend University Hospital NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2018-11-30
Completion
2018-11-30

Countries

  • United Kingdom

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 NCT02618161 on ClinicalTrials.gov