EORTC protocol 1414-ROG-GUCG: Phase IIIb randomized trial comparing irradiation plus long-term adjuvant androgen deprivation with GnRH antagonist versus GnRH agonist plus flare protection in patients with very high risk localized or locally advanced prostate cancer. A joint study of the EORTC ROG and GUCG. Pegasus

Conditions

very high risk localized or locally advanced prostate cancer

Brief summary

progression-free survival

Detailed description

1. Clinical progression-free survival, 2. Time to next systemic anticancer therapy, 3. Time to next systemic anticancer therapy other than ADT, 4. Proportion of patients switching from GnRH antagonists to GnRH agonists and total effective duration of treatment with the originally allocated drug., 5. Overall survival, 6. Prostate Cancer specific survival, 7. PSA, 8. The incidence of clinical cardiovascular events – CCE (i.e. arterial embolic or thrombotic events, hemorrhagic or ischemic cerebrovascular conditions, myocardial infarction, and other ischemic heart disease) in patients who had cardiovascular events before entering the trial and in those without such events., 9. The incidence of urinary tract infection, 10. Patient reported outcomes: (a) International Prostate Symptoms Score (I-PSS) (urinary symptoms); (b) Quality of Life (HRQoL) measured with EORTC QLQ-C30 and PR25 instruments with the overall health related quality of life scale as primary scale; (c) EQ-5L (to enable a future health economics analysis)

Related papers

No related papers found yet.

Interventions

DRUGDEGARELIX

DRUGGOSERELIN

DRUGTRIPTORELIN

DRUGLEUPRORELIN ACETATE

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
progression-free survival	—

Secondary

Measure	Time frame
1. Clinical progression-free survival, 2. Time to next systemic anticancer therapy, 3. Time to next systemic anticancer therapy other than ADT, 4. Proportion of patients switching from GnRH antagonists to GnRH agonists and total effective duration of treatment with the originally allocated drug., 5. Overall survival, 6. Prostate Cancer specific survival, 7. PSA, 8. The incidence of clinical cardiovascular events – CCE (i.e. arterial embolic or thrombotic events, hemorrhagic or ischemic cerebrovascular conditions, myocardial infarction, and other ischemic heart disease) in patients who had cardiovascular events before entering the trial and in those without such events., 9. The incidence of urinary tract infection, 10. Patient reported outcomes: (a) International Prostate Symptoms Score (I-PSS) (urinary symptoms); (b) Quality of Life (HRQoL) measured with EORTC QLQ-C30 and PR25 instruments with the overall health related quality of life scale as primary scale; (c) EQ-5L (to enable a fut	—

Measure

Time frame

1. Clinical progression-free survival, 2. Time to next systemic anticancer therapy, 3. Time to next systemic anticancer therapy other than ADT, 4. Proportion of patients switching from GnRH antagonists to GnRH agonists and total effective duration of treatment with the originally allocated drug., 5. Overall survival, 6. Prostate Cancer specific survival, 7. PSA, 8. The incidence of clinical cardiovascular events – CCE (i.e. arterial embolic or thrombotic events, hemorrhagic or ischemic cerebrovascular conditions, myocardial infarction, and other ischemic heart disease) in patients who had cardiovascular events before entering the trial and in those without such events., 9. The incidence of urinary tract infection, 10. Patient reported outcomes: (a) International Prostate Symptoms Score (I-PSS) (urinary symptoms); (b) Quality of Life (HRQoL) measured with EORTC QLQ-C30 and PR25 instruments with the overall health related quality of life scale as primary scale; (c) EQ-5L (to enable a fut

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Countries

Belgium, Germany, Spain

Outcome results

None listed