A Phase 2 interventional study of Bicalutamide and goserelin acetate in Prostate Cancer, sponsored by Fudan University. Status unknown at 1 site in China. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-07-07.
Sponsored by Fudan University · Phase 2, Interventional, and Treatment
The goal of this clinical research is to learn if treatment with androgen deprivation therapy in combination with surgery or radiation therapy can prolong the progression-free survival of oligometastatic prostate cancer than androgen deprivation therapy alone. The safety of this treatment combination will also be studied.
Today androgen deprivation therapy has been a standard treatment for metastatic prostate cancer, but as to the special type of prostate cancer-oligometastatic prostate cancer, except for androgen deprivation therapy, whether local treatment can be the part of treatment for it? The purpose of this study is to evaluate whether local treatment combined with androgen deprivation therapy can extend progression-free survival, as well as overall survival and life quality of patients of oligometastatic prostate cancer compared with androgen deprivation therapy alone.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 200 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.
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Exclusion Criteria:
Patients will receive androgen-deprivation therapy comprising luteinizing-hormone releasing-hormone (LHRH) agonist (leuprolide acetate, goserelin acetate, buserelin, or triptorelin) subcutaneously or as an injection AND an oral antiandrogen therapy (flutamide 3 times daily or bicalutamide once daily).
Drug: Bicalutamide · Drug: goserelin acetate · Drug: flutamide · Drug: leuprolide acetate · Drug: triptorelin
Patients will receive androgen-deprivation therapy as in arm I in addition to definitive treatment including surgery to remove prostate or radiation therapy to the prostate.
Drug: Bicalutamide · Drug: goserelin acetate · Drug: flutamide · Drug: leuprolide acetate · Drug: triptorelin · Procedure: Definitive Treatment
Given orally
Also known as: Casodex
Given subcutaneously or as an injection
Also known as: Zoladex
Given orally
Also known as: Eulexin
Given subcutaneously or as an injection
Also known as: Enantone
Given subcutaneously or as an injection
Also known as: Diphereline
surgery to remove prostate or radiation therapy to the prostate.
Progression-Free Survival (radiographic progression-free survival)
Time frame: 2 years
Overall survival
Time frame: 3 years
time of PSA progression
Time frame: 3 years
the quality of life
Quality of Life assessed by the EORTC QLQ-C30 questionnaire
Time frame: 3 years
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Fudan University