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

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ClinicalTrials.gov Identifier: NCT02618161
Recruitment Status : Completed
First Posted : December 1, 2015
Last Update Posted : October 29, 2020
Sponsor:
Information provided by (Responsible Party):
Southend University Hospital Foundation NHS Trust

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: HDR Brachytherapy Radiation: External beam Radiotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Feasibility Trial to Investigate the Timing of HDR Brachytherapy With EBRT in Intermediate and High Risk Localised Prostate CAncer Patients and Its Effects on Toxicity and Quality of Life
Study Start Date : September 2014
Actual Primary Completion Date : November 2018
Actual Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Arm A
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
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

Active Comparator: ARM B
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
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




Primary Outcome Measures :
  1. Prospective assessment of genitourinary toxicities according to the treatment sequence of HDR Brachytherapy and EBRT [ Time Frame: 12 months ]
    The Genitourinary toxicities are assessed according to CTCAE grading of toxicities (especially grade 3 and 4)


Secondary Outcome Measures :
  1. Biochemical response and survival [ Time Frame: 12 months ]
    PSA response in ug/L and its relation to survival rates at the end of year 1 follow up

  2. Gastrointestinal toxicities according to the treatment sequence of HDR Brachytherapy and EBRT [ Time Frame: 12 months ]
    Assessment of all CTCAE v4.0 grades of GI toxicities in both arms and the difference if any arise.

  3. Radiotherapy Planning Challenges including Image Guided Radiotherapy [ Time Frame: 12 months ]
    Assessment of timescales in planning the Radiotherapy and Brachytherapy once the patients entered in the trial and the number of patients received IGRT in the both arms.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  • If Anaesthesia is not possible
  • Rectal fistula
  • Prior pelvic radiotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02618161


Locations
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United Kingdom
Southend University Hospital NHS Foundation trust
Westcliff on sea, Essex, United Kingdom, SS0 0RY
Sponsors and Collaborators
Southend University Hospital Foundation NHS Trust
Investigators
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Principal Investigator: Imtiaz Ahmed, MRCP FRCR Southend University Hospital NHS Foundation Trust
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Responsible Party: Southend University Hospital Foundation NHS Trust
ClinicalTrials.gov Identifier: NCT02618161    
Other Study ID Numbers: P0845
First Posted: December 1, 2015    Key Record Dates
Last Update Posted: October 29, 2020
Last Verified: October 2020
Keywords provided by Southend University Hospital Foundation NHS Trust:
EBRT and HDR Brachytherapy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases