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

NCT02618161 | Completed DMC

• 1 other identifier: P0845
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Prostate Cancer

Keywords

EBRT and HDR Brachytherapy

Outcome Measures

Primary Outcomes (1)

• Prospective assessment of genitourinary toxicities according to the treatment sequence of HDR Brachytherapy and EBRT

  The Genitourinary toxicities are assessed according to CTCAE grading of toxicities (especially grade 3 and 4)

  12 months

Secondary Outcomes (3)

• Biochemical response and survival

  12 months

• Gastrointestinal toxicities according to the treatment sequence of HDR Brachytherapy and EBRT

  12 months

• Radiotherapy Planning Challenges including Image Guided Radiotherapy

  12 months

Study Arms (2)

Arm A

EXPERIMENTAL

HDR Brachytherapy single dose of 15 Gy followed by EBRT of 46 Gy in 23 fractions and Androgen deprivation therapy 6 months to 3 years, (sequencing of HDR followed by EBRT)

Radiation: HDR Brachytherapy; Radiation: External beam Radiotherapy

ARM B

ACTIVE COMPARATOR

External Beam Radiotherapy (EBRT) of 46 Gy in 23 fractions, followed by single dose of HDR brachytherapy of 15 Gy boost and Androgen deprivation therapy 6 months to 3 years (timing of HDR Brachytherapy Treatment is changed compared to ARM A)

Radiation: HDR Brachytherapy; Radiation: External beam Radiotherapy

Interventions

HDR Brachytherapy RADIATION

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

ARM B; Arm A

External beam Radiotherapy RADIATION

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

ARM B; Arm A

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Previous TURP/HoLEP Laser Prostatectomy
• Any Metastatic Disease
• IPSS\>20
• Pubic arch interference
• Lithotomy position
• If Anaesthesia is not possible
• Rectal fistula
• Prior pelvic radiotherapy

Sponsors & Collaborators

• Mid and South Essex NHS Foundation Trust: lead

Study Sites (1)

Southend Hospital

Westcliff-on-Sea, Essex, SS0 0RY, United Kingdom

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

• Imtiaz Ahmed, MRCP FRCR

  Southend University Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2015
• First Posted: December 1, 2015
• Study Start: September 1, 2014
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: December 22, 2020

Record last verified: 2020-12

Locations

GB (1)