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

Phase 2

• Conditions: Prostate Cancer
• Interventions: Drug: Bicalutamide; Drug: goserelin acetate; Drug: flutamide; Drug: leuprolide acetate; Drug: triptorelin; Procedure: Definitive Treatment

• Registration Number: NCT02742675
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-09
• Study First Submitted: 2016-04-11
• Study First Submitted QC: 2016-04-14
• Study First Posted: 2016-04-19
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-05
• Last Update Posted: 2020-07-07
• Primary Completion: 2021-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
androgen deprivation therapy	leuprolide acetate	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).
androgen deprivation therapy	goserelin acetate	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).
androgen deprivation therapy plus definitive treatment	goserelin acetate	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.
androgen deprivation therapy plus definitive treatment	leuprolide acetate	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.
androgen deprivation therapy plus definitive treatment	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.
androgen deprivation therapy	Bicalutamide	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).
androgen deprivation therapy	flutamide	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).
androgen deprivation therapy	triptorelin	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).
androgen deprivation therapy plus definitive treatment	Bicalutamide	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.
androgen deprivation therapy plus definitive treatment	flutamide	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.
androgen deprivation therapy plus definitive treatment	triptorelin	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.

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (radiographic progression-free survival)	2 years

Secondary Outcome Measures

Name	Time	Method
Overall survival	3 years
time of PSA progression	3 years
the quality of life	3 years	Quality of Life assessed by the EORTC QLQ-C30 questionnaire

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China