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

• Status: Active, not recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Androgens; Ascorbic Acid; Bicalutamide; Estrogens, Conjugated (USP); Flutamide; Goserelin; Leuprolide; Methyltestosterone; Triptorelin Pamoate

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.