# Systemic and Tumor-Directed Therapy for Oligometastatic Prostate Cancer

> **NIH VA I01** · VA GREATER LOS ANGELES HEALTHCARE SYSTEM · 2020 · —

## Abstract

Improving treatment of prostate cancer is critically relevant to Veterans' health. Prostate cancer is diagnosed in
more than 12,000 American Veterans annually and accounts for one third of all cancer diagnoses in American
male Veterans. It is the second leading cause of cancer death in American male Veterans. Metastatic prostate
cancer is incurable and treatment is palliative. The current standard of care is ADT (androgen deprivation
therapy); however, relapse is inevitable. Improved treatment strategies are needed.
Fortuitously, a recent confluence of diagnostic and treatment advances now raises the question if a multimodal
approach with aggressive, early treatment of newly diagnosed metastatic prostate cancer could be attempted
with curative intent in some patients. These advances include improved staging scans, proven benefits to early
initiation of docetaxel in patients with hormone sensitive disease, improvements in androgen suppressive
therapies (e.g., abiraterone acetate and apalutamide), and demonstration that stereotactic body radiotherapy
(SBRT) can offer control of metastatic sites in excess of 95%. We believe that these recent advances can and
should be leveraged to improve treatment efficacy for Veterans diagnosed with metastatic prostate cancer.
Retrospective data from our institution show that the outcomes of Veterans with newly diagnosed prostate
cancer limited to 1-5 sites of metastases (i.e., “oligometastases”) are superior to those of Veterans with greater
than 5 sites of metastasis, which has led our team to select patients with newly diagnosed metastatic prostate
cancer with 5 or fewer visible metastases for inclusion in a prospective Phase II clinical trial.
We propose a single arm Phase II clinical trial in patients with newly diagnosed M1a,b prostate cancer and 1-5
radiographically visible metastases staged by NaF PET-CT. In this trial, patients are treated with radical
prostatectomy (and post-operative fractionated radiotherapy for pT≥3a, pN1, and positive margins), metastasis
directed SBRT, six cycles of docetaxel, and complete ADT with GnRH analog leuprolide, abiraterone acetate,
and apalutamide for a total of six months of systemic therapy. The primary endpoint is the percent of patients
achieving a PSA <0.05 ng/mL six months after recovery of testosterone to ≥150 ng/dL, which is a surrogate for
disease control. Prior to enrollment, patients undergo a radiographic directed biopsy of a metastatic lesion to
confirm metastatic disease and obtain metastatic tumor tissue for correlative studies.
This trial will yield evaluable tissue (metastatic lesions through biopsy and the primary malignant prostate by
prostatectomy) from previously untreated prostate cancer patients with metastatic disease. Using this tissue,
we will identify the primary tumor in each patient that gave rise to the biopsied metastasis, and compare these
potentially lethal, “true” primaries with the other intraprostatic tumors that likely did not yield me...

## Key facts

- **NIH application ID:** 9932303
- **Project number:** 5I01CX001575-03
- **Recipient organization:** VA GREATER LOS ANGELES HEALTHCARE SYSTEM
- **Principal Investigator:** Nicholas George Nickols
- **Activity code:** I01 (R01, R21, SBIR, etc.)
- **Funding institute:** VA
- **Fiscal year:** 2020
- **Award amount:** —
- **Award type:** 5
- **Project period:** 2018-07-01 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9932303

## Citation

> US National Institutes of Health, RePORTER application 9932303, Systemic and Tumor-Directed Therapy for Oligometastatic Prostate Cancer (5I01CX001575-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9932303. Licensed CC0.

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