Prostate Cancer
Conditions
Keywords
prostate cancer, androgen deprivation therapy, local treatment
Brief summary
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.
Detailed description
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.
Interventions
DRUGBicalutamide
Given orally
DRUGgoserelin acetate
Given subcutaneously or as an injection
DRUGflutamide
Given orally
DRUGleuprolide acetate
Given subcutaneously or as an injection
DRUGtriptorelin
Given subcutaneously or as an injection
PROCEDUREDefinitive Treatment
surgery to remove prostate or radiation therapy to the prostate.
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Male patients; 2. 18 yrs and older, and 80 yrs and younger; 3. Histologically or cytologically proven prostate carcinoma; 4. Documented evidence of M1 disease by AJCC (American Joint Committee on Cancer) staging by Bone scan, CT and/or MRI; and metastatic lesions are limited to the lymph nodes or bones, at the same time the number of lesions should less than or equal to 5; 5. ECOG PS 0 or 1; 6. Treatment initiation with androgen deprivation therapy no longer than 6 months prior to randomization; 7. Life-expectancy based on comorbid conditions \>2 years; 8. No serious medical complications; 9. The primary lesion of prostate cancer has not yet received local treatment; 10. Must be a candidate for surgery and/or radiation therapy and follow-up and the treatment will not bring about serious complications to patients; 11. Ability to understand and willingness to sign informed consent.
Exclusion criteria
1. Had received treatment for primary lesion, including: radical prostatectomy, radical radiation therapy and so on; 2. Patients who received systemic chemotherapy before; 3. Androgen deprivation therapy time is greater than six months; 4. Visceral organ metastasis (liver, lung, brain and other organs); 5. Small cell carcinoma of the prostate; 6. Psychiatric or medical conditions which, in the opinion of the treating physician, would not allow the patient to undergo the proposed treatments safely; 7. Patients who are not willing to accept the complications caused by the treatment to primary lesion; 8. Combined with other malignant tumor history (in addition to the skin basal cell carcinoma or other tumors that have been cured more than five years); 9. Other serious diseases, for example: unstable heart disease after treatment, myocardial infarction in 6 months prior to treatment, cardiac function grade 3-4 (NYHA); high blood pressure that can not be controlled after medical treatment (greater than 150/90mmHg); serious neurological or mental disorders, including dementia and epilepsy; uncontrolled active infection; acute gastric ulcer; hypocalcemia; chronic obstructive pulmonary disease that needs hospital treatment; 10. Has participated in other clinical research before.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (radiographic progression-free survival) | 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 3 years | — |
| time of PSA progression | 3 years | — |
| the quality of life | 3 years | Quality of Life assessed by the EORTC QLQ-C30 questionnaire |
Countries
China
Outcome results
None listed