Androgen Deprivation Therapy or Androgen Deprivation Therapy Plus Definitive Treatment (Radiation or Surgery)

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02742675
• Other study ID #: FUSCC-OMPCa
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 2015
• Est. completion date: March 2023

Study information

• Verified date: July 2020
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: March 2023
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Bicalutamide
Given orally
• goserelin acetate
Given subcutaneously or as an injection
• flutamide
Given orally
• leuprolide acetate
Given subcutaneously or as an injection
• triptorelin
Given subcutaneously or as an injection

Procedure:
• Definitive Treatment
surgery to remove prostate or radiation therapy to the prostate.

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (radiographic progression-free survival)		2 years
Secondary	Overall survival		3 years
Secondary	time of PSA progression		3 years
Secondary	the quality of life	Quality of Life assessed by the EORTC QLQ-C30 questionnaire	3 years