PROSTATE: POST-PROSTATECTOMY: PSA RECURRENCE: NRG GU 006

A Phase II, Double-Blinded, Placebo Controlled Randomized Trial of Salvage Radiotherapy With or Without Enhanced Anti-androgen Therapy With Apalutamide in Recurrent Prostate Cancer

Title
NRG GU 006 (Prostate post-prostatectomy)
Study Title

A Phase II, Double-Blinded, Placebo Controlled Randomized Trial of Salvage Radiotherapy With or Without Enhanced Anti-androgen Therapy With Apalutamide in Recurrent Prostate Cancer

Site Link
Malignancy
Prostate Cancer
Stage
Disease Setting
Post-Recurrence
Line Of Therapy
1st Line post recurrence
Investigational Agent
Radiation +/- apalutamide
Drug Class
Androgen receptor inhibitor
PI
Dan Vaena, MD
Sponsor
NRG Oncology
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Prostate adenocarcinoma
  • Post-prostatectomy (within last 10 years)
  • Detectable serum PSA (between 0.1 and 1.0 ng/mL) at study entry
  • Any of following
    • Gleason score 7-10
    • >= T3a disease
    • PSA never became undetectable following prostatectomy
  • No nodal involvement
  • KPS 70-100
  • Availability of tissue
  • Prior ADT allowed if previously given for <90 days
  • GFR >35
  • No prior invasive malignancy except in-situ disease, stage I resected melanoma, or disease free for at least 2 years
  • No prior chemotherapy for prostate cancer
  • No prior radiation that would result in overlap
  • No history or predisposition to seizures
  • No IBD
  • No severe CAD
Objective
  • Primary- Biochemical PFS
  • Secondary-
    • Patient reported morbidity
    • MD reported morbidity
    • Cancer Specific Mortality
    • Distant metastasis
    • Local regional progression
    • Initiation of salvage hormonal therapy
    • Metastatis Free Survival
    • OS
    • PSA Nadir in 1st year of tx
    • Undectable PSA rate
Assessment Frequency
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Assessment Frequency 2
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Assessment Frequency Link
Path
Adenocarcinoma
Dosing Frequency
Control Agents
Placebo
Study Protocol
Randomized
Yes
X