Clinical trial NCT02742675: Androgen Deprivation Therapy or Androgen Deprivation Therapy Plus Definitive Treatment (Radiation or Surgery)
Official title: OMPCa-Shanghai: An Open-label, Randomized Prospective Phase II Trial of Androgen Deprivation Therapy or Androgen Deprivation Therapy Plus Definitive Treatment (Radiation or Surgery) of the Primary Tumor in Oligometastatic Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: prostate cancer
androgen deprivation therapy
local treatment
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2016-04-19
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression-Free Survival (radiographic progression-free survival)
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival
timeFrame: 3 years
measure: time of PSA progression
timeFrame: 3 years
measure: the quality of life
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Ye Dingwei, MD
role: PRINCIPAL_INVESTIGATOR
References: