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

July 5, 2020 updated by: Ding-Wei Ye, Fudan University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: androgen deprivation therapy
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).
Drug: flutamide
Given orally
Other Names:
  • Eulexin
Drug: Bicalutamide
Given orally
Other Names:
  • Casodex
Drug: goserelin acetate
Given subcutaneously or as an injection
Other Names:
  • Zoladex
Drug: leuprolide acetate
Given subcutaneously or as an injection
Other Names:
  • Enantone
Drug: triptorelin
Given subcutaneously or as an injection
Other Names:
  • Diphereline
Experimental: androgen deprivation therapy plus definitive treatment
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.
Drug: flutamide
Given orally
Other Names:
  • Eulexin
Drug: Bicalutamide
Given orally
Other Names:
  • Casodex
Drug: goserelin acetate
Given subcutaneously or as an injection
Other Names:
  • Zoladex
Drug: leuprolide acetate
Given subcutaneously or as an injection
Other Names:
  • Enantone
Drug: triptorelin
Given subcutaneously or as an injection
Other Names:
  • Diphereline
Procedure: Definitive Treatment
surgery to remove prostate or radiation therapy to the prostate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-Free Survival (radiographic progression-free survival)
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 3 years
3 years
time of PSA progression
Time Frame: 3 years
3 years
the quality of life
Time Frame: 3 years
Quality of Life assessed by the EORTC QLQ-C30 questionnaire
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Ye Dingwei, MD, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Anticipated)

March 1, 2021

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

April 11, 2016

First Submitted That Met QC Criteria

April 14, 2016

First Posted (Estimate)

April 19, 2016

Study Record Updates

Last Update Posted (Actual)

July 7, 2020

Last Update Submitted That Met QC Criteria

July 5, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUSCC-OMPCa

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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