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Trial record 27 of 1543 for:    Androgens

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

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ClinicalTrials.gov Identifier: NCT02742675
Recruitment Status : Unknown
Verified April 2016 by Ding-Wei Ye, Fudan University.
Recruitment status was:  Recruiting
First Posted : April 19, 2016
Last Update Posted : April 19, 2016
Sponsor:
Information provided by (Responsible Party):
Ding-Wei Ye, Fudan University

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
Prostate Cancer Drug: Bicalutamide Drug: goserelin acetate Drug: flutamide Drug: leuprolide acetate Drug: triptorelin Procedure: Definitive Treatment 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Start Date : March 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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 Name: Casodex

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

Drug: flutamide
Given orally
Other Name: Eulexin

Drug: leuprolide acetate
Given subcutaneously or as an injection
Other Name: Enantone

Drug: triptorelin
Given subcutaneously or as an injection
Other Name: 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 Name: Casodex

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

Drug: flutamide
Given orally
Other Name: Eulexin

Drug: leuprolide acetate
Given subcutaneously or as an injection
Other Name: Enantone

Drug: triptorelin
Given subcutaneously or as an injection
Other Name: Diphereline

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




Primary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 3 years ]
  2. time of PSA progression [ Time Frame: 3 years ]
  3. the quality of life [ Time Frame: 3 years ]
    Quality of Life assessed by the EORTC QLQ-C30 questionnaire



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02742675


Contacts
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Contact: Ye Dingwei, MD +86-21 64175590 dwyeli@163.com

Locations
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China, Shanghai
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China, 200032
Contact: Ye Dingwei, MD    +86-21 64175590      
Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: Ye Dingwei, MD Fudan University

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Responsible Party: Ding-Wei Ye, Principal Investigator, Fudan University
ClinicalTrials.gov Identifier: NCT02742675     History of Changes
Other Study ID Numbers: FUSCC-OMPCa
First Posted: April 19, 2016    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ding-Wei Ye, Fudan University:
prostate cancer
androgen deprivation therapy
local treatment
Additional relevant MeSH terms:
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Androgens
Androgen Antagonists
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Ascorbic Acid
Methyltestosterone
Leuprolide
Goserelin
Triptorelin Pamoate
Flutamide
Bicalutamide
Estrogens, Conjugated (USP)
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Vitamins
Micronutrients
Nutrients
Growth Substances
Estrogens
Antineoplastic Agents, Hormonal
Antineoplastic Agents