A Phase 2 interventional study of Abiraterone acetate with prednisone and Leuprolide in Prostate Cancer, sponsored by University Health Network, Toronto. Completed at 5 sites in Canada. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-31.
Sponsored by University Health Network, Toronto · Phase 2, Interventional, and Treatment
This study evaluates the use of chemotherapy with cabazitaxel in addition to abiraterone acetate, prednisone, and leuprolide in neoadjuvant setting prior to radical prostatectomy in patients with high-risk prostate carcinoma. Half of the participants will receive treatment with abiraterone acetate, prednisone, leuprolide, and cabazitaxel, while the other half will receive only abiraterone acetate, prednisone, and leuprolide.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 76 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants randomized to this arm will receive abiraterone acetate (1000 mg/day), prednisone (5 mg twice daily), leuprolide (22.5 mg every 3 months), and cabazitaxel (20 mg/m2, with 6 mg pegfilgrastim administered 24 h following cabazitaxel) prior to radical prostatectomy.
Drug: Abiraterone acetate with prednisone · Drug: Leuprolide · Drug: Cabazitaxel with peg-filgrastim
Participants randomized to this arm will receive abiraterone acetate (1000 mg/day) , prednisone (5 mg twice daily), and leuprolide (22.5 mg every 3 months) prior to radical prostatectomy.
Drug: Abiraterone acetate with prednisone · Drug: Leuprolide
Abiraterone acetate will be administered orally as a tablet at 1000 mg/day with prednisone (5 mg oral tablet, twice daily) for 24 weeks.
Leuprolide will be administered by subcutaneous injection at 22.5 mg dose every 12 weeks for 24 weeks.
Cabazitaxel will be administered in 6 cycles, with 20 mg/m2 per cycle and 3 weeks between cycles.
Pathological complete response
Time frame: 24 weeks from start of treatment.
Pre-operative PSA levels
The effect of neoadjuvant leuprolide, and abiraterone acetate and prednisone with and without cabazitaxel on pre-operative PSA will be evaluated.
Time frame: 24 weeks of treatment
Mean nadir PSA levels
The effect of neoadjuvant leuprolide, abiraterone acetate, and prednisone with and without cabazitaxel on mean nadir PSA levels will be evaluated.
Time frame: 24 weeks of treatment
Percentage of participants achieving a PSA < 0.2 ng/mL
The percentage of participants achieving a PSA \< 0.2 ng/mL following treatment with neoadjuvant leuprolide, abiraterone acetate, and prednisone with and without cabazitaxel will be evaluated.
Time frame: 24 weeks of treatment
Percentage of participants achieving a 50 and 90% decrease in PSA levels
The percentage of participants achieving a 50 and 90% decrease in PSA levels following treatment with neoadjuvant leuprolide, abiraterone acetate, and prednisone with and without cabazitaxel will be evaluated.
Time frame: up to 24 weeks of treatment
Rate of positive surgical margins
The rate of positive surgical margins following treatment with neoadjuvant leuprolide, abiraterone acetate, and prednisone with and without cabazitaxel will be evaluated.
Time frame: up to 24 weeks of treatment
Rate of near-complete response (<5 mm tumour)
The rate of near-complete response (\<5 mm tumour) following treatment with neoadjuvant leuprolide, abiraterone acetate, and prednisone with and without cabazitaxel will be evaluated.
Time frame: up to 24 weeks of treatment
Rate of extracapsular extension
The rate of extracapsular extension following treatment with neoadjuvant leuprolide, abiraterone acetate, and prednisone with and without cabazitaxel will be evaluated.
Time frame: up to 24 weeks of treatment
Rate of positive seminal vesicle involvement
The rate of positive seminal vesicle involvement following treatment with neoadjuvant leuprolide, abiraterone acetate, and prednisone with and without cabazitaxel will be evaluated.
Time frame: up to 24 weeks of treatment
Rate of nodal involvement
The rate of nodal involvement following treatment with neoadjuvant leuprolide, abiraterone acetate, and prednisone with and without cabazitaxel will be evaluated.
Time frame: up to 24 weeks of treatment
Tumour proliferation (Ki-67 index)
Tumour proliferation, indexed using Ki-67 immunohistochemistry, following treatment with neoadjuvant leuprolide, abiraterone acetate, and prednisone with and without cabazitaxel will be evaluated.
Time frame: up to 24 weeks of treatment
Androgen receptor expression
Androgen receptor expression will be evaluated using immunohistochemistry following treatment with neoadjuvant leuprolide, abiraterone acetate, and prednisone with and without cabazitaxel.
Time frame: up to 24 weeks of treatment
Incidence of adverse events
Incidence of adverse events will be evaluated for the duration of the study.
Time frame: up to 24 weeks of treatment
Severity of adverse events
Severity of adverse events will be evaluated for the duration of the study.
Time frame: Aup to 24 weeks of treatment
Androgen levels (if optional biopsy tissue is available)
If the participants agrees to optional pre-treatment biopsy, androgen levels will be compared between the pre-treatment tissue samples and prostatectomy tissue.
Time frame: up to 24 weeks of treatment
Genomic alterations between pre- and post-treatment tissue
If the participants agrees to optional pre-treatment biopsy, genomic alterations between the pre-treatment tissue samples and prostatectomy tissue will be evaluated.
Time frame: up to 24 weeks of treatment
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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University Health Network, Toronto