Hemi-Ablative Prostate Brachytherapy - Full Text View

Purpose

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	Intervention
Prostatic Neoplasms Cancer of the Prostate	Radiation: Hemi gland focal LDR brachytherapy


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: prostate cancer

MedlinePlus related topics: Prostate Cancer

U.S. FDA Resources

Further study details as provided by Stephen Langley, Royal Surrey County Hospital NHS Foundation Trust:

Primary Outcome Measures:

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.
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.
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.
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:

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.


Estimated Enrollment:	34
Study Start Date:	November 2013
Estimated Study Completion Date:	June 2018
Estimated Primary Completion Date:	June 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

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Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

TRUS biopsy (if taken):

unilateral disease only
Template biopsy (TTB):

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

Exclusion Criteria:

Men who have had previous radiation therapy
Men who have had androgen suppression/hormone treatment within the previous 12 months for their prostate cancer
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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02632669

Contacts


Contact: Ceri Jamieson	44(0)1483406612	cerijamieson@nhs.net
Contact: Stephen Langley, MD	44(0)1483406612	stephenlangley@nhs.net

Locations


United Kingdom
Royal Surrey NHS Foundation Trust	Recruiting
Guildford, United Kingdom, GU2 7XX
Contact: Ceri Jamieson 44(0)1483406612 cerijamieson@nhs.net
Contact: Stephen Langley, MD 44(0)1483406612 stephenlangley@nhs.net

Sponsors and Collaborators

Royal Surrey County Hospital NHS Foundation Trust

Investigators


Principal Investigator:	Stephen Langley, MD	Royal Surrey NHS Foundation Trust

More Information

Publications:

Ahmed HU, Pendse D, Illing R, Allen C, van der Meulen JH, Emberton M. Will focal therapy become a standard of care for men with localized prostate cancer? Nat Clin Pract Oncol. 2007 Nov;4(11):632-42. Review.

Eggener SE, Scardino PT, Carroll PR, Zelefsky MJ, Sartor O, Hricak H, Wheeler TM, Fine SW, Trachtenberg J, Rubin MA, Ohori M, Kuroiwa K, Rossignol M, Abenhaim L; International Task Force on Prostate Cancer and the Focal Lesion Paradigm. Focal therapy for localized prostate cancer: a critical appraisal of rationale and modalities. J Urol. 2007 Dec;178(6):2260-7. Epub 2007 Oct 15. Review.

Langley S, Ahmed HU, Al-Qaisieh B, Bostwick D, Dickinson L, Veiga FG, Grimm P, Machtens S, Guedea F, Emberton M. Report of a consensus meeting on focal low dose rate brachytherapy for prostate cancer. BJU Int. 2012 Feb;109 Suppl 1:7-16. doi: 10.1111/j.1464-410X.2011.10825.x. Review.

Al-Qaisieh B, Mason J, Bownes P, Henry A, Dickinson L, Ahmed HU, Emberton M, Langley S. Dosimetry Modeling for Focal Low-Dose-Rate Prostate Brachytherapy. Int J Radiat Oncol Biol Phys. 2015 Jul 15;92(4):787-93. doi: 10.1016/j.ijrobp.2015.02.043. Epub 2015 Apr 28.

Langley SE, Laing RW. 4D Brachytherapy, a novel real-time prostate brachytherapy technique using stranded and loose seeds. BJU Int. 2012 Feb;109 Suppl 1:1-6. doi: 10.1111/j.1464-410X.2011.10824.x. Review.

McCulloch P, Altman DG, Campbell WB, Flum DR, Glasziou P, Marshall JC, Nicholl J; Balliol Collaboration, Aronson JK, Barkun JS, Blazeby JM, Boutron IC, Campbell WB, Clavien PA, Cook JA, Ergina PL, Feldman LS, Flum DR, Maddern GJ, Nicholl J, Reeves BC, Seiler CM, Strasberg SM, Meakins JL, Ashby D, Black N, Bunker J, Burton M, Campbell M, Chalkidou K, Chalmers I, de Leval M, Deeks J, Ergina PL, Grant A, Gray M, Greenhalgh R, Jenicek M, Kehoe S, Lilford R, Littlejohns P, Loke Y, Madhock R, McPherson K, Meakins J, Rothwell P, Summerskill B, Taggart D, Tekkis P, Thompson M, Treasure T, Trohler U, Vandenbroucke J. No surgical innovation without evaluation: the IDEAL recommendations. Lancet. 2009 Sep 26;374(9695):1105-12. doi: 10.1016/S0140-6736(09)61116-8.

Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. PLoS Med. 2010 Mar 24;7(3):e1000251. doi: 10.1371/journal.pmed.1000251.

von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies. Int J Surg. 2014 Dec;12(12):1495-9. doi: 10.1016/j.ijsu.2014.07.013. Epub 2014 Jul 18.

Barentsz JO, Weinreb JC, Verma S, Thoeny HC, Tempany CM, Shtern F, Padhani AR, Margolis D, Macura KJ, Haider MA, Cornud F, Choyke PL. Synopsis of the PI-RADS v2 Guidelines for Multiparametric Prostate Magnetic Resonance Imaging and Recommendations for Use. Eur Urol. 2016 Jan;69(1):41-9. doi: 10.1016/j.eururo.2015.08.038. Epub 2015 Sep 8.


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
Study First Received:	November 16, 2015
Last Updated:	December 17, 2015

Keywords provided by Stephen Langley, Royal Surrey County Hospital NHS Foundation Trust:


Focal brachytherapy Seed implant Quality of life Toxicity

Additional relevant MeSH terms:


Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site	Neoplasms Genital Diseases, Male Prostatic Diseases

ClinicalTrials.gov processed this record on July 14, 2017

Hemi-Ablative Prostate Brachytherapy (HAPpy)