search
Back to results

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

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Bicalutamide
goserelin acetate
flutamide
leuprolide acetate
triptorelin
Definitive Treatment
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, androgen deprivation therapy, local treatment

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Fudan University Shanghai Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

androgen deprivation therapy

androgen deprivation therapy plus definitive treatment

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Progression-Free Survival (radiographic progression-free survival)

Secondary Outcome Measures

Overall survival
time of PSA progression
the quality of life
Quality of Life assessed by the EORTC QLQ-C30 questionnaire

Full Information

First Posted
April 11, 2016
Last Updated
July 5, 2020
Sponsor
Fudan University
search

1. Study Identification

Unique Protocol Identification Number
NCT02742675
Brief Title
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (Actual)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, androgen deprivation therapy, local treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
androgen deprivation therapy
Arm Type
Experimental
Arm Description
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).
Arm Title
androgen deprivation therapy plus definitive treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bicalutamide
Other Intervention Name(s)
Casodex
Intervention Description
Given orally
Intervention Type
Drug
Intervention Name(s)
goserelin acetate
Other Intervention Name(s)
Zoladex
Intervention Description
Given subcutaneously or as an injection
Intervention Type
Drug
Intervention Name(s)
flutamide
Other Intervention Name(s)
Eulexin
Intervention Description
Given orally
Intervention Type
Drug
Intervention Name(s)
leuprolide acetate
Other Intervention Name(s)
Enantone
Intervention Description
Given subcutaneously or as an injection
Intervention Type
Drug
Intervention Name(s)
triptorelin
Other Intervention Name(s)
Diphereline
Intervention Description
Given subcutaneously or as an injection
Intervention Type
Procedure
Intervention Name(s)
Definitive Treatment
Intervention Description
surgery to remove prostate or radiation therapy to the prostate.
Primary Outcome Measure Information:
Title
Progression-Free Survival (radiographic progression-free survival)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
3 years
Title
time of PSA progression
Time Frame
3 years
Title
the quality of life
Description
Quality of Life assessed by the EORTC QLQ-C30 questionnaire
Time Frame
3 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male patients; 18 yrs and older, and 80 yrs and younger; Histologically or cytologically proven prostate carcinoma; 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; ECOG PS 0 or 1; Treatment initiation with androgen deprivation therapy no longer than 6 months prior to randomization; Life-expectancy based on comorbid conditions >2 years; No serious medical complications; The primary lesion of prostate cancer has not yet received local treatment; Must be a candidate for surgery and/or radiation therapy and follow-up and the treatment will not bring about serious complications to patients; Ability to understand and willingness to sign informed consent. Exclusion Criteria: Had received treatment for primary lesion, including: radical prostatectomy, radical radiation therapy and so on; Patients who received systemic chemotherapy before; Androgen deprivation therapy time is greater than six months; Visceral organ metastasis (liver, lung, brain and other organs); Small cell carcinoma of the prostate; Psychiatric or medical conditions which, in the opinion of the treating physician, would not allow the patient to undergo the proposed treatments safely; Patients who are not willing to accept the complications caused by the treatment to primary lesion; 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); 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; Has participated in other clinical research before.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ye Dingwei, MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs