# Advanced PET-CT Directed Post-Prostatectomy Radiotherapy to Enhance Prostate Cancer Outcomes

> **NIH NIH R01** · EMORY UNIVERSITY · 2021 · $651,443

## Abstract

Project Summary / Abstract
Currently, 50% of patients who have undergone post-prostatectomy radiotherapy after PSA failure manifest
subsequent systemic disease. Compared to PET/CT with molecular radiotracers, conventional imaging
methods fall short in identifying sites of prostate cancer recurrence. Our goal is to address an unmet public
health need by improving long term biochemical control of patients with recurrent prostate carcinoma.
 We have verified a key scientific premise that advanced molecular imaging with the synthetic amino
acid PET radiotracer fluciclovine (18F) (anti-3-[18F]FACBC) results in significantly greater disease
detection, with a 40.5% change in management and 83.6% change in planning volumes (without dose
escalation) compared with conventional imaging. During the course of our trial, and in large part because
of our translational work, fluciclovine (18F) was FDA approved in 2016 for recurrent prostate cancer,
contributing to a new standard of care. As of Version 1.2018, fluciclovine (18F) has now been included in the
National Comprehensive Cancer Network (NCCN) Guidelines for restaging recurrent prostate cancer.
Moreover, salvage radiotherapy is being offered at increasingly lower PSA levels, and evidence is
accumulating that boosting radiotherapy dose to foci of active disease may result in clinical benefit.
Preliminary analysis of still accruing data from our ongoing clinical trial (5R01CA129356: NCT01666808)
suggests that integrating fluciclovine may result in a small improvement in failure rate, but not have adequate
sensitivity to definitively achieve durable PSA control with standard radiotherapy doses. Yet, there is early
evidence that a new class of PET radiotracer targeting the prostate specific membrane antigen (PSMA)
receptor may have greater sensitivity at lower PSA levels for disease detection. Gallium-68 (68Ga) PSMA is
one such PSMA PET ligand, though not FDA approved. Each class of PET radiotracer, amino acid metabolic
(fluciclovine) vs receptor based (PSMA), exhibits advantages and disadvantages.
 Our hypothesis is that by utilizing a higher affinity PET ligand, we can better select and manage
patients who will benefit from salvage radiotherapy undertaken at lower PSA levels. In addition, we
hypothesize that by dose escalating targets identified with either fluciclovine (18F) or 68Ga PSMA, we
will determine if dose escalation in itself provides improved PSA control. To test these hypotheses with
the highest scientific rigor, we will conduct a prospective clinical trial in which patients who are eligible for
salvage radiotherapy are randomized to either fluciclovine (18F) or 68Ga PSMA PET/CT. We will explore if
positive specific tissue biomarker signatures may be useful to help predicts post-prostatectomy radiotherapy
outcomes in combination with the standard risk criteria. Our proposal is timely since recent editorials in the
literature regarding salvage radiotherapy post-prostatectomy call for integration ...

## Key facts

- **NIH application ID:** 10132259
- **Project number:** 5R01CA226992-03
- **Recipient organization:** EMORY UNIVERSITY
- **Principal Investigator:** Ashesh Jani
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $651,443
- **Award type:** 5
- **Project period:** 2019-05-01 → 2024-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10132259

## Citation

> US National Institutes of Health, RePORTER application 10132259, Advanced PET-CT Directed Post-Prostatectomy Radiotherapy to Enhance Prostate Cancer Outcomes (5R01CA226992-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10132259. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*