- Title
- A randomised trial investigating the effect on biochemical (PSA) control and survival of different durations of adjuvant androgen deprivation in association with definitive radiation treatment for localised carcinoma of the prostate
- Creator
- Lamb, David; Joesph, David; Turner, Sandra; Diamond, Terry; Steigler, Allison; Attia, John; Delahunt, Brett; Haworth, Annette; Denham, Jim; Duchesne, Gillian; Atkinson, Chris; Kenny, Lizbeth; Gogna, Kumar; Matthews, John; Spry, Nigel; Tai, Keen-Hun
- Relation
- Trans-Tasman Radiation Oncology Group Incorporated (TROG) TROG 03.04
- Resource Type
- protocol
- Description
- The principal objective of the trial is to test the hypothesis that 12 months adjuvant androgen deprivation using Leuprorelin acetate starting immediately after standard therapy (ie 6 months of Leuprorelin acetate before and during radiotherapy) will reduce prostate cancer-specific mortality (PCSM) when compared with standard therapy alone. There are three secondary objectives: (a) to test the hypotheses that 12 months adjuvant androgen deprivation (specified above) will reduce PSA progression (PSA-P), local progression (LP), distant progression (DP), secondary therapeutic intervention (STI), all-cause mortality (ACM), and improve quality of life (QOL); (b) to test the hypotheses that 18 months of bisphosphonate therapy using zoledronic acid will reduce osteopenic fractures (OPF), improve bone mineral density (BMD), delay or prevent the onset of bony progression (BP) or metastases at any site (distant progression [DP]), delay or prevent secondary therapeutic intervention (STI), and improve quality of life (QOL) when compared to patients in this trial who are not treated with bisphosphonate therapy; (c) to determine the nature of interactions between the total duration of androgen deprivation and: (i) the addition of bisphosphonate therapy; (ii) increasing radiation dose, within the structured radiation dose escalation program built into the design of the trial, with respect to LP, DP and PSA progression; (iii) increasing Gleason score with respect to all-cause mortality; and the interaction between the use of bisphosphonate therapy and Gleason score at the ≤7/>7 cutpoint identified in 2014 for the BP and STI endpoints. A tertiary objective of the trial is to determine whether intercurrent medical conditions will impact independently on delayed radiotherapy morbidity and other treatment related morbidity.
- Subject
- protocol; androgen suppression; Leuprorelin acetate; radiotherapy; cancer treatment; prostate cancer; bisphosphonate; zoledronic acid; high dose rate brachytherapy
- Identifier
- http://hdl.handle.net/1959.13/1391555
- Identifier
- uon:33247
- Rights
- CC-BY. This work is licensed under a Creative Commons Attribution 4.0 International License.
- Language
- eng
- Full Text
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