The goal of this study is to determine whether the addition of Androgen Deprivation Therapy (ADT) utilizing the study drug ELIGARD® to Recurrence- Directed Therapy (RDT) improves progression-free survival (PFS) compared to RDT alone in patients with early radio-recurrent oligo-metastatic castrate / hormone sensitive prostate cancer (romCSPC). Participants will be assessed at standard of care clinic visits every 3 months. The follow-up period is 36 months.
A multi-centre, open-label, phase II randomized clinical trial evaluating the addition of Androgen Deprivation Therapy (ADT) utilizing the study drug ELIGARD® compared to Recurrence Directed Therapy (RDT) alone in patients with previously localized prostate adenocarcinoma treated with definitive radiotherapy or with salvage radiotherapy after radical prostatectomy who experience biochemical recurrence and present with oligo-metastases (i.e., \< 5 sites of metastases) on conventional imaging. Eligible and consenting patents will be randomized in a 1:1 fashion to either RDT alone (standard arm) or RDT +ADT (ELIGARD®) x12 months (experimental arm). During treatment study participants will be assessed for disease progression, development of castrate resistant prostate cancer (CRPC), acute and late genitourinary (GU) and gastrointestinal (GI) radiotherapy toxicity, the occurrence of adverse events, initiation of tertiary therapy, overall survival and quality of life through the completion of participant questionnaires. Participants will be assessed at standard of care clinic visits every 3 months. The follow-up period is 36 months from the date of randomization. The planned sample size is 162 study participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
162
RDT options include radiotherapy or surgical resection.
ADT in the form of ELIGARD 22.5 mg every 3 months for a total of 12 months.
Juravinski Cancer Centre
Hamilton, Ontario, Canada
The Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, Canada
Composite progression free survival
Biochemical, radiological or clinical progression \[composite PFS (cPFS) event\]
Time frame: Time from randomization to the occurrence of composite PFS event occurring up to the 36 month follow-up.
Disease progression
Disease progression: time to biochemical progression (bPFS) (proportion of bPFS events); Disease progression: proportion of conventional-imaging based progression (rPFS) (proportion of rPFS events); Disease progression: proportion with eugonadal progression (egPFS)
Time frame: Time from date of randomization, until the date of progression or death occurring up to the 36 month follow-up.
Time to initiation of tertiary therapy;
Any non-protocol treatment given for prostate cancer after protocol-specified intervention.
Time frame: Time of initial therapy to 36 month follow-up.
Proportion of patients that develop castrate-resistant prostate cancer (CRPC)
Proportion of patients that develop castrate-resistant prostate cancer (CRPC)
Time frame: During the 36 month follow-up.
Overall survival.
Overall survival.
Time frame: During the 36 month follow-up.
Rate of early and late Grade 3 or higher GU and GI toxicity.
The rate of early and late Grade 3 or higher GU and GI toxicity will be assessed at baseline, 3, 6, 15 and 36 months. The CTCAEv.5.0 (\> Grade 3, GI and GU) toxicity rates will be reported.
Time frame: At 3, 6, 15 and 36 months.
Quality of life assessed by EORTC QLQ C30
Study participant reported quality of life utilizing the following measurement EORTC QLQ C30
Time frame: Completed by the study participant at scheduled follow-up visits (Months 3, 6, 15 and 36).
Quality of life assessed by EORTC QLQ PR25 questionnaire
Time frame: Completed by the study participant at scheduled follow-up visits (Months 3, 6, 15 and 36).
Quality of life assessed by EORTC QLQ PRT20 questionnaire
Time frame: Completed by the study participant at scheduled follow-up visits (Months 3, 6, 15 and 36).
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