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Gonadorelin

GnRH, Luteinizing Hormone-Releasing Hormone, LHRH, Factrel

Quick Stats
Studies 192
Trials 100
Completed PHASE2 INTERVENTIONAL NCT03298087

Systemic and Tumor-Directed Therapy for Oligometastatic Prostate Cancer

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This is a trial for patients with newly diagnosed metastatic prostate cancer with 5 or fewer sites of metastases. The trial involves surgery (removal of the prostate) or radiation to the prostate, six months of hormone therapy, and stereotactic body radiotherapy to the sites of metastasis.

Detailed Description

This is a single arm Phase II clinical trial in patients with newly diagnosed M1a,b prostate cancer and 1-5 radiographically visible metastases treated with radical prostatectomy (and post-operative fractionated radiotherapy for pT 3a, pN1, or positive margins) or radiation to the prostate, metastasis directed SBRT, and complete ADT with LHRH analog leuprolide, abiraterone acetate with prednisone, and apalutamide (ARN-509) for a total of six months of systemic therapy. The primary endpoint of our study is the percent of patients achieving a serum PSA of \<0.05 ng/mL six months after recovery of serum testosterone (for patients undergoing radical prostatectomy) or PSA \<nadir+2 (for patients undergoing prostate radiation).

Interventions

Name: radical prostatectomy
Type: PROCEDURE
Description: surgical removal of the prostate
Name: stereotactic body radiotherapy
Type: RADIATION
Description: Highly targeted radiation
Name: Leuprolide
Type: DRUG
Description: Lowers serum testosterone
Name: apalutamide
Type: DRUG
Description: antiandrogen
Name: abiraterone
Type: DRUG
Description: Inhibits androgen synthesis

Primary Outcomes

Measure: Percentage of Participants With PSA<0.05ng/mL (Radical Prostatectomy) or PSA <Nadir+2ng/mL (Prostate Radiation)
TimeFrame: 6 months after recovery of testosterone
Description: PSA is a biomarker for disease burden in prostate adenocarcinoma and offers a non-invasive and sensitive assessment of disease control after treatment in the vast majority of patients.

Trial Information

NCT ID

NCT03298087

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

VA Office of Research and Development

Last Updated

December 15, 2025