Hemi-Ablative Prostate Brachytherapy

NCT02632669 | Completed

• 1 other identifier: R&D12oncn0015
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Neoplasms; Cancer of the Prostate

Keywords

Focal brachytherapy; Seed implant; Quality of life; Toxicity

Outcome Measures

Primary Outcomes (4)

• Treatment related Urinary toxicity (symptoms) as recorded by the IPSS questionnaire score.

  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 years

• Treatment related Quality of Life (QoL) due to urinary symptoms as recorded by the Quality of Life (QoL) component of the IPSS questionnaire score.

  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.

  2 years

• 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.

  The EORTC-QLQ-PR25 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.

  2 years

• Treatment related adverse events on Erectile function as recorded by the International Index of Erectile Function 5 (IIEF 5) questionnaire score.

  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.

  2 years

Secondary Outcomes (1)

• To evaluate tumor control of hemigland focal brachytherapy

  2 years

Study Arms (1)

Hemigland focal LDR brachytherapy

EXPERIMENTAL

Hemigland focal LDR brachytherapy using permanent iodine 125 seed implantation

Radiation: Hemigland focal LDR brachytherapy

Interventions

Hemigland focal LDR brachytherapy RADIATION

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.

Hemigland focal LDR brachytherapy

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Surrey County Hospital NHS Foundation Trust: lead

Study Sites (1)

Royal Surrey NHS Foundation Trust

Guildford, GU2 7XX, United Kingdom

Location

Related Publications (11)

• 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. doi: 10.1038/ncponc0959.

  PMID: 17965641 BACKGROUND

• 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. doi: 10.1016/j.juro.2007.08.072. Epub 2007 Oct 15.

  PMID: 17936815 BACKGROUND

• 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.

  PMID: 22239224 BACKGROUND

• 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.

  PMID: 25936808 BACKGROUND

• 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.

  PMID: 22239223 BACKGROUND

• 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.

  PMID: 19782876 BACKGROUND

• 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.

  PMID: 20352064 BACKGROUND

• von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche 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.

  PMID: 25046131 BACKGROUND

• 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. No abstract available.

  PMID: 26361169 BACKGROUND

• Laing R, Franklin A, Uribe J, Horton A, Uribe-Lewis S, Langley S. Hemi-gland focal low dose rate prostate brachytherapy: An analysis of dosimetric outcomes. Radiother Oncol. 2016 Nov;121(2):310-315. doi: 10.1016/j.radonc.2016.09.014. Epub 2016 Nov 1.

  PMID: 27814981 RESULT

• Langley S, Uribe J, Uribe-Lewis S, Franklin A, Perna C, Horton A, Cunningham M, Higgins D, Deering C, Khaksar S, Laing R. Hemi-ablative low-dose-rate prostate brachytherapy for unilateral localised prostate cancer. BJU Int. 2020 Mar;125(3):383-390. doi: 10.1111/bju.14948. Epub 2019 Dec 23.

  PMID: 31705700 RESULT

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

• Stephen Langley, MD

  Royal Surrey NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Urology & Clinical Director Royal Surrey & St Luke's Cancer Centre

Study Record Dates

• First Submitted: November 16, 2015
• First Posted: December 17, 2015
• Study Start: July 6, 2012
• Primary Completion: June 20, 2018
• Study Completion: August 31, 2018
• Last Updated: November 1, 2022

Record last verified: 2022-10

Locations

GB (1)