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

Fudan University

Status and phase: Unknown; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: goserelin acetate; Drug: leuprolide acetate; Drug: flutamide; Drug: triptorelin; Procedure: Definitive Treatment; Drug: Bicalutamide

Study type: Interventional

Funder types: Other

Identifiers

NCT02742675

FUSCC-OMPCa

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

androgen deprivation therapy

Experimental group

Description:

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).

Treatment:

Drug: Bicalutamide

Drug: triptorelin

Drug: flutamide

Drug: leuprolide acetate

Drug: goserelin acetate

androgen deprivation therapy plus definitive treatment

Experimental group

Description:

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.

Treatment:

Procedure: Definitive Treatment

Drug: Bicalutamide

Drug: triptorelin

Drug: flutamide

Drug: leuprolide acetate

Drug: goserelin acetate