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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| androgen deprivation therapy | Experimental | 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). |
|
| androgen deprivation therapy plus definitive treatment | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bicalutamide | Drug | Given orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (radiographic progression-free survival) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 3 years | |
| time of PSA progression | 3 years | |
| the quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ye Dingwei, MD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35780048 | Derived | Dai B, Zhang S, Wan FN, Wang HK, Zhang JY, Wang QF, Kong YY, Ma XJ, Mo M, Zhu Y, Qin XJ, Lin GW, Ye DW. Combination of Androgen Deprivation Therapy with Radical Local Therapy Versus Androgen Deprivation Therapy Alone for Newly Diagnosed Oligometastatic Prostate Cancer: A Phase II Randomized Controlled Trial. Eur Urol Oncol. 2022 Oct;5(5):519-525. doi: 10.1016/j.euo.2022.06.001. Epub 2022 Jun 29. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C053541 | bicalutamide |
| D017273 | Goserelin |
| D005485 | Flutamide |
| D016729 | Leuprolide |
| D017329 | Triptorelin Pamoate |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| goserelin acetate | Drug | Given subcutaneously or as an injection |
|
|
| flutamide | Drug | Given orally |
|
|
| leuprolide acetate | Drug | Given subcutaneously or as an injection |
|
|
| triptorelin | Drug | Given subcutaneously or as an injection |
|
|
| Definitive Treatment | Procedure | surgery to remove prostate or radiation therapy to the prostate. |
|
Quality of Life assessed by the EORTC QLQ-C30 questionnaire
| 3 years |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |