CompletedPhase 2

Best Systemic Therapy or Best Systemic Therapy (BST) Plus Definitive Treatment (Radiation or Surgery)

United States, Canada180 participantsStarted 2013-03-18

Plain-language summary

The goal of this clinical research study is to learn if treatment with standard systemic therapy (androgen deprivation therapy or bilateral orchiectomy) in combination with surgery or radiation therapy is more effective at controlling prostate cancer than standard systemic therapy alone. The safety of this treatment combination will also be studied.

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male patients
✓. 18 yrs and older
✓. Histologically or cytologically proven prostate carcinoma
✓. Documented evidence of M1 disease by AJCC (American Joint Committee on Cancer) staging by Bone scan, CT and/or MRI.
✓. Androgen dependent disease measured by declining PSA and do not display signs of progression demonstrated by a rising PSA.
✓. Treatment initiation with BST no longer than 6 months prior to randomization
✓. ECOG PS 0 or 1
✓. Life-expectancy based on comorbid conditions \>2 years

Exclusion criteria

✕. Psychiatric or medical conditions which, in the opinion of the treating physician, would not allow the patient to undergo the proposed treatments safely.
✕. Known brain metastasis
✕. Small cell carcinoma of the prostate
✕. Any laboratory abnormalities, which in the opinion of the investigator, may put the subject at risk if participating in the study. For example: AST + ACT \> 2 upper limits of normal value; WBC \< 2.0; Hgb \< 7.0.

What they're measuring

Progression-Free Survival

Timeframe: 60 days

Trial details

NCT IDNCT01751438

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-19

View on ClinicalTrials.gov More Prostate Cancer trials