West Cancer Center

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

NCT03371719

Malignancy

Prostate Cancer

Stage

Stage 3

Disease Setting

Post-Recurrence

Line Of Therapy

1st Line post recurrence

Investigational Agent

Radiation +/- apalutamide

Drug Class

Androgen receptor inhibitor

Dan Vaena, MD

Sponsor

NRG Oncology

Phase

Phase 2

Status

Closed to Accrual

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

Assessment Frequency 2

Assessment Frequency Link

Path

Adenocarcinoma

Dosing Frequency

Control Agents

Placebo

Study Protocol

Randomized

Yes