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

Sponsor
Fudan University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02742675
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
90
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 1, 2015
Anticipated Primary Completion Date :
Mar 1, 2021
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

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: Bicalutamide
Given orally
Other Names:
  • Casodex

    • Drug: goserelin acetate
    Given subcutaneously or as an injection
    Other Names:
  • Zoladex

    • Drug: flutamide
    Given orally
    Other Names:
  • Eulexin

    • 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: Bicalutamide
    Given orally
    Other Names:
  • Casodex

    • Drug: goserelin acetate
    Given subcutaneously or as an injection
    Other Names:
  • Zoladex

    • Drug: flutamide
    Given orally
    Other Names:
  • Eulexin

    • 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.

    Outcome Measures

    Primary Outcome Measures

    1. Progression-Free Survival (radiographic progression-free survival) [2 years]

    Secondary Outcome Measures

    1. Overall survival [3 years]

    2. time of PSA progression [3 years]

    3. the quality of life [3 years]

      Quality of Life assessed by the EORTC QLQ-C30 questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    Male
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fudan University Shanghai Cancer Center Shanghai Shanghai China 200032

    Sponsors and Collaborators

    • Fudan University

    Investigators

    • Principal Investigator: Ye Dingwei, MD, Fudan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ding-Wei Ye, Principal Investigator, Fudan University
    ClinicalTrials.gov Identifier:
    NCT02742675
    Other Study ID Numbers:
    • FUSCC-OMPCa
    First Posted:
    Apr 19, 2016
    Last Update Posted:
    Jul 7, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Ding-Wei Ye, Principal Investigator, Fudan University
    prostate cancer
    androgen deprivation therapy
    local treatment
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Leuprolide
    Goserelin
    Triptorelin Pamoate
    Flutamide
    Bicalutamide

    Study Results

    No Results Posted as of Jul 7, 2020