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Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer

Clinical Trial Details

The purpose of this study is to compare the effects (good and/or bad) of adding either prostate removal surgery or radiation therapy to standard systemic therapy (SST), which is used to treat prostate cancer. Standard systemic therapy includes Androgen Deprivation Therapy (ADT) with or without the use of chemotherapy. ADT is an antihormone therapy that’s main use is to treat prostate cancer.   

The usual approach for patients who are not in a study is to start treatment ADT drugs with or without chemotherapy. These medications can cause prostate cancer to slow its growth, may reduce any symptoms from prostate cancer and will help patients live longer. All of the drugs that are used as part of treatment on this study are FDA approved and considered standard treatment for prostate cancer, however, the combination of SST and surgery or radiation therapy is considered experimental, which means the combination has not yet been approved by the FDA.

Participants in this study will be randomized to receive either only standard systemic therapy (SST) or SST plus either surgery to remove the prostate or radiation therapy. The choice of radiation or surgery is up to participants and the study team if assigned to that group.

All participants will receive treatment until it is no longer beneficial. Once treatment is completed, the doctor and study team will continue to follow participants for up to 8 years.

Key Eligibility: 
  1. Open to men, aged 18 and older, with a confirmed diagnosis of prostate cancer. 
  2. Participants must not have known brain metastases.
  3. Participants must not have received any prior systemic therapy for prostate cancer, outside of line of SST.

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Angela Tan, RN
212-746-4154
ant4009@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1810019687

ClinicalTrials.gov:

NCT03678025

Sponsor:

S1802

Status

Open to Enrollment

Age Group

Adult

Sponsor

Disease