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

NCT ID: NCT02742675

Last Updated: 2020-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2023-03-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Bicalutamide

Intervention Type: DRUG

Given orally

goserelin acetate

Intervention Type: DRUG

Given subcutaneously or as an injection

flutamide

Intervention Type: DRUG

Given orally

leuprolide acetate

Intervention Type: DRUG

Given subcutaneously or as an injection

triptorelin

Intervention Type: DRUG

Given subcutaneously or as an injection

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.

Group Type: EXPERIMENTAL

Bicalutamide

Intervention Type: DRUG

Given orally

goserelin acetate

Intervention Type: DRUG

Given subcutaneously or as an injection

flutamide

Intervention Type: DRUG

Given orally

leuprolide acetate

Intervention Type: DRUG

Given subcutaneously or as an injection

triptorelin

Intervention Type: DRUG

Given subcutaneously or as an injection

Definitive Treatment

Intervention Type: PROCEDURE

surgery to remove prostate or radiation therapy to the prostate.

Interventions

Bicalutamide

Given orally

Intervention Type: DRUG

goserelin acetate

Given subcutaneously or as an injection

Intervention Type: DRUG

flutamide

Given orally

Intervention Type: DRUG

leuprolide acetate

Given subcutaneously or as an injection

Intervention Type: DRUG

triptorelin

Given subcutaneously or as an injection

Intervention Type: DRUG

Definitive Treatment

surgery to remove prostate or radiation therapy to the prostate.

Intervention Type: PROCEDURE

Other Intervention Names

Casodex; Zoladex; Eulexin; Enantone; Diphereline

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Ding-Wei Ye

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ye Dingwei, MD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Countries

China

References

Dai B, Zhang S, Wan FN, Wang HK, Zhang JY, Wang QF, Kong YY, Ma XJ, Mo M, Zhu Y, Qin XJ, Lin GW, Ye DW. Combination of Androgen Deprivation Therapy with Radical Local Therapy Versus Androgen Deprivation Therapy Alone for Newly Diagnosed Oligometastatic Prostate Cancer: A Phase II Randomized Controlled Trial. Eur Urol Oncol. 2022 Oct;5(5):519-525. doi: 10.1016/j.euo.2022.06.001. Epub 2022 Jun 29.

Reference Type: DERIVED

PMID: 35780048 (View on PubMed)

Other Identifiers

FUSCC-OMPCa

Identifier Type: -

Identifier Source: org_study_id