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SABRE 1 (Surgery Against Brachytherapy - a Randomised Evaluation): feasibility randomised controlled trial (RCT) of brachytherapy vs radical prostatectomy in low-intermediate risk clinically localised prostate cancer

SABRE 1 (Surgery Against Brachytherapy - a Randomised Evaluation): feasibility randomised controlled trial (RCT) of brachytherapy vs radical prostatectomy in low-intermediate risk clinically localised prostate cancer
SABRE 1 (Surgery Against Brachytherapy - a Randomised Evaluation): feasibility randomised controlled trial (RCT) of brachytherapy vs radical prostatectomy in low-intermediate risk clinically localised prostate cancer

OBJECTIVE: To determine the feasibility of a phase III randomised controlled trial of brachytherapy vs radical prostatectomy (RP) in men with low-intermediate risk localised prostate cancer.

PATIENTS AND METHODS: This parallel, two-group, multicentre, randomised controlled feasibility trial enrolled men with histologically confirmed localised, low-risk prostate cancer and good performance status from five UK hospitals. Participants were randomly allocated (1:1) by remote computer allocation to receive a decision aid (DA) DVD or standard information (control group), followed by a second randomisation (1:1) to brachytherapy or RP. There was no 'blinding' of staff or patients. Primary outcome was feasibility: a recruitment rate of six patients per centre over the last 6 months of recruitment would deem a phase III trial feasible.

RESULTS: Between May 2009 and May 2011, 30 patients were randomised (15 in the DA group and 15 in the control group), and four continued to the second treatment randomisation (one from the DA group and three from the control group). One patient was allocated and received brachytherapy and three RP. SABRE 1 closed early due to poor recruitment. All patients were analysed. Screening logbook analysis showed that the main reasons for declining trial entry were a wish to choose treatment or opting for active monitoring. Results from the DA questionnaire (completed by 10 men) showed that four of the men 'felt surgery and radiotherapy had been proven in a high quality trial' and seven felt 'they should make their treatment decision while knowing their doctors opinion'.

CONCLUSION: Recruitment to a RP vs brachytherapy trial in localised prostate cancer was not feasible by the use of this two-step randomisation using a DA and previous trials in early prostate cancer have had similar difficulties in recruitment, with only a few achieving their accrual target. The best treatment method for treating low-risk prostate cancer is still unproven in a head-to-head trial and the increasing number of options will make choices correspondingly more difficulty without good quality comparative research. More sophisticated techniques for recruitment may be more successful in future trials in this patient population.

Brachytherapy, Feasibility Studies, Humans, Male, Prostatectomy, Prostatic Neoplasms, Risk Assessment, Risk Factors, Surveys and Questionnaires, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
1464-4096
330-7
Eccles, Bryony K
57ff1cdf-577d-421d-8f35-b12b8d1c2030
Cross, William
5fba4a57-8d96-44c2-95bf-260ba8a8d45a
Rosario, Derek J
692789e4-89a4-4d0d-9cbb-94473a1765c4
Doble, Andrew
f4a95d16-0313-4e96-a314-0fa0032b1226
Parker, Chris
c403bb72-f89c-403c-967c-75639ce03c53
Logue, John
ef9bc80f-8d10-4f70-b3f7-e61840e76f75
Little, Louisa
41f55532-898e-41a6-97c6-2802a379d684
Stanton, Louise
8b827763-d839-4b4b-bbf2-358a84110294
Bottomley, David
e1e6d1a8-93c9-4f85-8f63-b5609f2d6be8
Eccles, Bryony K
57ff1cdf-577d-421d-8f35-b12b8d1c2030
Cross, William
5fba4a57-8d96-44c2-95bf-260ba8a8d45a
Rosario, Derek J
692789e4-89a4-4d0d-9cbb-94473a1765c4
Doble, Andrew
f4a95d16-0313-4e96-a314-0fa0032b1226
Parker, Chris
c403bb72-f89c-403c-967c-75639ce03c53
Logue, John
ef9bc80f-8d10-4f70-b3f7-e61840e76f75
Little, Louisa
41f55532-898e-41a6-97c6-2802a379d684
Stanton, Louise
8b827763-d839-4b4b-bbf2-358a84110294
Bottomley, David
e1e6d1a8-93c9-4f85-8f63-b5609f2d6be8

Eccles, Bryony K, Cross, William, Rosario, Derek J, Doble, Andrew, Parker, Chris, Logue, John, Little, Louisa, Stanton, Louise and Bottomley, David (2013) SABRE 1 (Surgery Against Brachytherapy - a Randomised Evaluation): feasibility randomised controlled trial (RCT) of brachytherapy vs radical prostatectomy in low-intermediate risk clinically localised prostate cancer. BJU International, 112 (3), 330-7. (doi:10.1111/bju.12127).

Record type: Article

Abstract

OBJECTIVE: To determine the feasibility of a phase III randomised controlled trial of brachytherapy vs radical prostatectomy (RP) in men with low-intermediate risk localised prostate cancer.

PATIENTS AND METHODS: This parallel, two-group, multicentre, randomised controlled feasibility trial enrolled men with histologically confirmed localised, low-risk prostate cancer and good performance status from five UK hospitals. Participants were randomly allocated (1:1) by remote computer allocation to receive a decision aid (DA) DVD or standard information (control group), followed by a second randomisation (1:1) to brachytherapy or RP. There was no 'blinding' of staff or patients. Primary outcome was feasibility: a recruitment rate of six patients per centre over the last 6 months of recruitment would deem a phase III trial feasible.

RESULTS: Between May 2009 and May 2011, 30 patients were randomised (15 in the DA group and 15 in the control group), and four continued to the second treatment randomisation (one from the DA group and three from the control group). One patient was allocated and received brachytherapy and three RP. SABRE 1 closed early due to poor recruitment. All patients were analysed. Screening logbook analysis showed that the main reasons for declining trial entry were a wish to choose treatment or opting for active monitoring. Results from the DA questionnaire (completed by 10 men) showed that four of the men 'felt surgery and radiotherapy had been proven in a high quality trial' and seven felt 'they should make their treatment decision while knowing their doctors opinion'.

CONCLUSION: Recruitment to a RP vs brachytherapy trial in localised prostate cancer was not feasible by the use of this two-step randomisation using a DA and previous trials in early prostate cancer have had similar difficulties in recruitment, with only a few achieving their accrual target. The best treatment method for treating low-risk prostate cancer is still unproven in a head-to-head trial and the increasing number of options will make choices correspondingly more difficulty without good quality comparative research. More sophisticated techniques for recruitment may be more successful in future trials in this patient population.

Full text not available from this repository.

More information

Published date: August 2013
Additional Information: © 2013 BJU International.
Keywords: Brachytherapy, Feasibility Studies, Humans, Male, Prostatectomy, Prostatic Neoplasms, Risk Assessment, Risk Factors, Surveys and Questionnaires, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
Organisations: Clinical Informatics Research Unit, Clinical Trials Unit

Identifiers

Local EPrints ID: 408795
URI: http://eprints.soton.ac.uk/id/eprint/408795
ISSN: 1464-4096
PURE UUID: feee3998-951b-4ce8-95d5-b711f324ebc0
ORCID for Louise Stanton: ORCID iD orcid.org/0000-0001-8181-840X

Catalogue record

Date deposited: 28 May 2017 04:01
Last modified: 26 Nov 2019 01:43

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Contributors

Author: Bryony K Eccles
Author: William Cross
Author: Derek J Rosario
Author: Andrew Doble
Author: Chris Parker
Author: John Logue
Author: Louisa Little
Author: Louise Stanton ORCID iD
Author: David Bottomley

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