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Hemi-Ablative Prostate Brachytherapy (HAPpy)

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ClinicalTrials.gov Identifier: NCT02632669
Recruitment Status : Active, not recruiting
First Posted : December 17, 2015
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Stephen Langley, Royal Surrey County Hospital NHS Foundation Trust

Brief Summary:

This clinical study will evaluate side effects, quality of life and cancer control in patients with prostate cancer diagnosed on only one side of the prostate gland.

The diagnosis of unilateral prostate cancer will be made by means of a prostate transperineal template biopsy (TTB) and multiparametric magnetic resonance imaging (mpMRI).

Patients will be treated with low dose rate brachytherapy, using permanent iodine seed implants.Treatment will be limited to the side of the gland where the cancer has been diagnosed and is therefore called "focal" brachytherapy.

Prostate brachytherapy is usually applied to the whole prostate gland. After whole gland prostate brachytherapy urinary, bowel and sexual function may be affected. In this focal approach, the side effects will be evaluated by means of patient questionnaires.These will be repeated at various intervals after treatment.The results will be compared to the same questionnaires responded by patients who have undergone whole gland brachytherapy.Therefore an assessment can be made whether focal therapy produces fewer side effects than whole gland brachytherapy.The observation period will last for two years after treatment. A biopsy and mpMRI will be repeated after two years to evaluate prostate cancer control.


Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Cancer of the Prostate Radiation: Hemi gland focal LDR brachytherapy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Stage 2S Clinical Trial Evaluating Hemi-Ablative Low Dose Rate (LDR) Brachytherapy for Localised Prostate Cancer
Study Start Date : November 2013
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Hemi gland focal LDR brachytherapy
Hemi gland focal LDR brachytherapy using permanent iodine 125 seed implantation
Radiation: Hemi gland focal LDR brachytherapy
The treatment is limited to the hemigland that has been diagnosed with unilateral low to intermediate risk prostate cancer by means of pre - treatment staging with mpMRI and transperineal template biopsy. The affected hemigland will be treated with iodine 125 to a prescription dose of 145Gy. Patients will be assessed at baseline and subsequently at 6 weeks,3,6,9,12,18,24 months after treatment with PSA and EN2 measurements and validated questionnaires relating to erectile, urinary, and bowel function and general health related quality of life. mpMRI and transperineal template biopsy will be performed 24 months after treatment.




Primary Outcome Measures :
  1. Treatment related Urinary toxicity (symptoms) as recorded by the IPSS questionnaire score. [ Time Frame: 2 years ]
    The International Prostate Symptom Score (IPSS) validated questionnaire will be used to score urinary toxicity (symptoms) after hemigland focal brachytherapy. Scores (mild = 0 to 7; moderate = 8 to 19; severe = 20 to 35) will be obtained pre-treatment and the outcomes reported as the change in score at 6 weeks, 3, 6, 9, 12, 18 and 24 months after treatment.

  2. Treatment related Quality of Life (QoL) due to urinary symptoms as recorded by the Quality of Life (QoL) component of the IPSS questionnaire score. [ Time Frame: 2 years ]
    The QoL component of the IPSS questionnaire will be used to score QoL due to urinary symptoms that may arise after hemigland focal brachytherapy. Scores (good = 0 to 2 ; acceptable = 3 to 4 ; poor = 5 to 6) will be obtained pre-treatment and the outcomes reported as the change in score at 6 weeks, 3, 6, 9, 12, 18 and 24 months after treatment.

  3. Treatment related bowel toxicity (symptoms) as recorded by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) questionnaire (30 PR 25) score. [ Time Frame: 2 years ]
    The EORTC QoL 30 PR 25 questionnaire will be used to score bowel toxicity (symptoms) after hemigland focal brachytherapy. Scores (normal bowel function = 4; mild bowel toxicity = 5 to 8 ; moderate toxicity = 9 to 12 ; severe toxicity = 13 to 16) will be obtained pre-treatment and the outcomes reported as the change in score at 6 weeks, 3, 6, 9, 12, 18 and 24 months after treatment.

  4. Treatment related adverse events on Erectile function as recorded by the International Index of Erectile Function 5 (IIEF 5) questionnaire score. [ Time Frame: 2 years ]
    The IIEF 5 validated questionnaire will be used to score erectile function after hemigland focal brachytherapy. Scores (no erectile dysfunction (ED) = 22 to 25; mild ED = 17 to 21; mild to moderate ED = 12 to 16; moderate ED = 8 to 11; severe ED = 5 to 7) will be obtained pre-treatment and the outcomes reported as the change in score at 6 weeks, 3, 6, 9,12,18 and 24 months after treatment.


Secondary Outcome Measures :
  1. To evaluate tumor control of hemigland focal brachytherapy [ Time Frame: 2 years ]
    The absence of clinically significant cancer in either treated or untreated prostate hemigland will be determined by Gleason score of transperineal template biopsy cores together with PI-RADS score of MRI imaging (T2, DWI and DCE) at two years after treatment.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. TRUS biopsy (if taken):

    unilateral disease only

  2. Template biopsy (TTB):

    unilateral disease only, AND Gleason < 7 (either 3+4 or 4+3)

  3. mp-MRI results: Disease must present as unilateral (left or right) only
  4. Stage T1-T2bN0M0 disease, as determined by local guidelines *
  5. Serum PSA < 15
  6. Prostate volume < 50cc
  7. Eligible for brachytherapy as outlined in local guidelines*
  8. Life expectancy > 10 years

Exclusion Criteria:

  1. Men who have had previous radiation therapy
  2. Men who have had androgen suppression/hormone treatment within the previous 12 months for their prostate cancer
  3. Men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging.

    • https://www.rcr.ac.uk/quality-assurance-practice-guidelines-transperineal-ldr-permanent-seed-brachytherapy-prostate-cancer

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): NCT02632669


Locations
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United Kingdom
Royal Surrey NHS Foundation Trust
Guildford, United Kingdom, GU2 7XX
Sponsors and Collaborators
Royal Surrey County Hospital NHS Foundation Trust
Investigators
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Principal Investigator: Stephen Langley, MD Royal Surrey NHS Foundation Trust

Publications:

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Responsible Party: Stephen Langley, Professor of Urology & Clinical Director Royal Surrey & St Luke's Cancer Centre, Royal Surrey County Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02632669     History of Changes
Other Study ID Numbers: R&D12oncn0015
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stephen Langley, Royal Surrey County Hospital NHS Foundation Trust:
Focal brachytherapy
Seed implant
Quality of life
Toxicity
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases