Trial in progress: PRESTIGE—Primary retroperitoneal lymph node dissection (RPLND) for clinical stage II (CSII) testicular germ cell tumour (TGCT) and its impact on health-related quality of life (HRQoL) compared to chemotherapy or radiotherapy.

Conduit, C; Lewin, JH; Liow, ECH; Dhillon, HM; Hong, W; De Abreu Lourenço, R; Lawrentschuk, N; Thomas, B; Grimison, PS; Ahmadi, N; Sengupta, S; Tran, B

Trial in progress: PRESTIGE—Primary retroperitoneal lymph node dissection (RPLND) for clinical stage II (CSII) testicular germ cell tumour (TGCT) and its impact on health-related quality of life (HRQoL) compared to chemotherapy or radiotherapy.

Conduit, C Lewin, JH Liow, ECH Dhillon, HM Hong, W De Abreu Lourenço, R Lawrentschuk, N Thomas, B Grimison, PS Ahmadi, N Sengupta, S Tran, B

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Publisher:: American Society of Clinical Oncology (ASCO)
Publication Type:: Journal Article
Citation:: Journal of Clinical Oncology, 2023, 41, (6_suppl), pp. tps433-tps433
Issue Date:: 2023-02-20

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Field	Value	Language
dc.contributor.author	Conduit, C
dc.contributor.author	Lewin, JH
dc.contributor.author	Liow, ECH
dc.contributor.author	Dhillon, HM
dc.contributor.author	Hong, W
dc.contributor.author	De Abreu Lourenço, R
dc.contributor.author	Lawrentschuk, N
dc.contributor.author	Thomas, B
dc.contributor.author	Grimison, PS
dc.contributor.author	Ahmadi, N
dc.contributor.author	Sengupta, S
dc.contributor.author	Tran, B
dc.date.accessioned	2024-05-29T20:19:37Z
dc.date.available	2024-05-29T20:19:37Z
dc.date.issued	2023-02-20
dc.identifier.citation	Journal of Clinical Oncology, 2023, 41, (6_suppl), pp. tps433-tps433
dc.identifier.issn	0732-183X
dc.identifier.issn	1527-7755
dc.identifier.uri	http://hdl.handle.net/10453/179331
dc.description.abstract	<jats:p> TPS433 </jats:p><jats:p> Background: As cure rates for patients with advanced TGCT improve, there is increasing focus on quality of survival. Increasingly, primary RPLND is being used as an alternative to chemotherapy (and radiotherapy) as primary treatment for selected individuals, due to the development of low morbidity surgical techniques (robot-assisted and extraperitoneal approaches), and recognition of acute and long-term toxicity of chemotherapy and radiotherapy. We hypothesise that primary RPLND compared to chemotherapy and radiotherapy will have less detrimental impact on HRQoL with comparable oncological outcomes. Methods: PRESTIGE is a prospective cohort study among adults with histologically confirmed advanced TGCT planned for primary RPLND, chemotherapy or radiotherapy. Eligible patients may have de novo advanced disease, or relapse within two- (NSGCT) or three-years (seminoma) following orchidectomy, without prior chemotherapy or radiotherapy (including adjuvant), and able to complete HRQoL questionnaires in English. See table for cohort-specific eligibility. Surgical approach (modality, template, adjuvant chemotherapy), chemotherapy regimen and radiotherapy dose will be administered at physician discretion and captured in Australia’s national multi-centre TGCT registry, iTestis, with clinical data in follow-up. Participants will complete HRQoL questionnaires focusing on physical, social, emotional, and functional domains commencing prior to treatment and continuing for 24 months. Questionnaires include EORTC QLQ-C30, EORTC QLQ-TC26, Brief Male Sexual Function Inventory and specific questions focusing on retrograde ejaculation and fertility. Patients undergoing RPLND will also have miR-371 evaluation pre-operatively and serially for 12 months after surgery. The primary outcome is change in EORTC QLQ-C30 global health status over 24 months for participants undergoing primary RPLND. Key secondary outcomes are changes in HRQoL, patterns of recurrence, surgical complications, retrograde ejaculation, and infertility. A sample size of 90 participants (30 for RPLND, 60 for chemotherapy) provides >80% power to detect a mean difference of 28% in global health status at 0.05 significance favouring RPLND. Up to 30 individuals receiving radiotherapy may also be enrolled. The first site was activated 4-Aug-22; 2 of 3 study sites are active and 5 out of a planned 120 (4%) participants have enrolled. [Table: see text] </jats:p>
dc.language	en
dc.publisher	American Society of Clinical Oncology (ASCO)
dc.relation.ispartof	Journal of Clinical Oncology
dc.relation.isbasedon	10.1200/jco.2023.41.6_suppl.tps433
dc.rights	info:eu-repo/semantics/closedAccess
dc.subject	1103 Clinical Sciences, 1112 Oncology and Carcinogenesis
dc.subject.classification	Oncology & Carcinogenesis
dc.subject.classification	3211 Oncology and carcinogenesis
dc.title	Trial in progress: PRESTIGE—Primary retroperitoneal lymph node dissection (RPLND) for clinical stage II (CSII) testicular germ cell tumour (TGCT) and its impact on health-related quality of life (HRQoL) compared to chemotherapy or radiotherapy.
dc.type	Journal Article
utslib.citation.volume	41
utslib.for	1103 Clinical Sciences
utslib.for	1112 Oncology and Carcinogenesis
pubs.organisational-group	University of Technology Sydney
pubs.organisational-group	University of Technology Sydney/Faculty of Health
pubs.organisational-group	University of Technology Sydney/Strength - CHERE - Centre for Health Economics Research and Evaluation
pubs.organisational-group	University of Technology Sydney/Strength - CHT - Health Technologies
pubs.organisational-group	University of Technology Sydney/Faculty of Health/Centre for Health Economics Research and Evaluation
utslib.copyright.status	closed_access	*
dc.date.updated	2024-05-29T20:19:36Z
pubs.issue	6_suppl
pubs.publication-status	Published
pubs.volume	41
utslib.citation.issue	6_suppl

Abstract:

TPS433 Background: As cure rates for patients with advanced TGCT improve, there is increasing focus on quality of survival. Increasingly, primary RPLND is being used as an alternative to chemotherapy (and radiotherapy) as primary treatment for selected individuals, due to the development of low morbidity surgical techniques (robot-assisted and extraperitoneal approaches), and recognition of acute and long-term toxicity of chemotherapy and radiotherapy. We hypothesise that primary RPLND compared to chemotherapy and radiotherapy will have less detrimental impact on HRQoL with comparable oncological outcomes. Methods: PRESTIGE is a prospective cohort study among adults with histologically confirmed advanced TGCT planned for primary RPLND, chemotherapy or radiotherapy. Eligible patients may have de novo advanced disease, or relapse within two- (NSGCT) or three-years (seminoma) following orchidectomy, without prior chemotherapy or radiotherapy (including adjuvant), and able to complete HRQoL questionnaires in English. See table for cohort-specific eligibility. Surgical approach (modality, template, adjuvant chemotherapy), chemotherapy regimen and radiotherapy dose will be administered at physician discretion and captured in Australia’s national multi-centre TGCT registry, iTestis, with clinical data in follow-up. Participants will complete HRQoL questionnaires focusing on physical, social, emotional, and functional domains commencing prior to treatment and continuing for 24 months. Questionnaires include EORTC QLQ-C30, EORTC QLQ-TC26, Brief Male Sexual Function Inventory and specific questions focusing on retrograde ejaculation and fertility. Patients undergoing RPLND will also have miR-371 evaluation pre-operatively and serially for 12 months after surgery. The primary outcome is change in EORTC QLQ-C30 global health status over 24 months for participants undergoing primary RPLND. Key secondary outcomes are changes in HRQoL, patterns of recurrence, surgical complications, retrograde ejaculation, and infertility. A sample size of 90 participants (30 for RPLND, 60 for chemotherapy) provides >80% power to detect a mean difference of 28% in global health status at 0.05 significance favouring RPLND. Up to 30 individuals receiving radiotherapy may also be enrolled. The first site was activated 4-Aug-22; 2 of 3 study sites are active and 5 out of a planned 120 (4%) participants have enrolled. [Table: see text]

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http://hdl.handle.net/10453/179331