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. 2024 Aug 21;31(8):4781-4794.
doi: 10.3390/curroncol31080358.

Challenges and Opportunities in Developing an Oncology Clinical Trial Network in the United States Veterans Affairs Health Care System: The VA STARPORT Experience

Abhishek A Solanki  1   2 , Kevin Zheng  3 , Alicia N Skipworth  1 , Lisa M Robin  4 , Ryan F Leparski  4 , Elizabeth Henry  1 , Matthew Rettig  5 , Joseph K Salama  6 , Timothy Ritter  7 , Jeffrey Jones  8 , Marcus Quek  1   9 , Michael Chang  7 , Alec M Block  1   2 , James S Welsh  1   2 , Aryavarta Kumar  10 , Hann-Hsiang Chao  7 , Albert C Chen  8 , Ronald Shapiro  11 , Rhonda L Bitting  6 , Robert Kwon  12 , William Stross  13 , Lindsay Puckett  14 , Yu-Ning Wong  15 , Nicholas G Nickols  5 , Kimberly Carlson  4 ; VA STARPORT Investigators Group
Affiliations

Challenges and Opportunities in Developing an Oncology Clinical Trial Network in the United States Veterans Affairs Health Care System: The VA STARPORT Experience

Abhishek A Solanki et al. Curr Oncol. .

Abstract

The United States Veterans Affairs (VA) Health Care System has a strong history of conducting impactful oncology randomized clinical trials (RCTs). We developed a phase II/III RCT to test the use of metastasis-directed therapy in Veterans with oligometastatic prostate cancer (OMPC)-the first VA RCT in OMPC that leverages novel imaging and advanced radiotherapy techniques. To accomplish this, we developed a clinical trial network to conduct the study. In this manuscript, we describe several challenges we encountered in study development/conduct and our strategies to address them, with the goal of helping investigators establish robust study networks to conduct clinical trials. In the study start-up, we encountered challenges in timely site activation, and leveraged project management to maximize efficiency. Additionally, there were several changes in the clinical paradigms in imaging and treatment that led to protocol amendments to ensure maximum equipoise, recruitment, and impact of the study. Specifically, we amended the trial to add de novo OMPC patients (from initially only recurrent OMPC) and expanded the study to allow up to 10 metastases (from initially five). Finally, in order to maintain local study team engagement, we developed initiatives to maximize collaboration and add value to the overall clinical program through study participation.

Keywords: oligometastasis; prostate cancer; radiotherapy; randomized clinical trial; recruitment; site selection; veterans.

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Conflict of interest statement

The funders had no role in the design of this study, in the collection, analyses, or interpretation of the data, in the writing of this manuscript, or in the decision to publish the results. The following authors disclose their conflicts of interest: N.N. received research funding from Janssen, Lantheus, and Bayer, and personal fees from PrimeFour; M.R. received research funding from Merck, Lantheus, Janssen, Fusion, Novartis, and AstraZeneca, is a consultant for INmune Bio, Aveo, and Bayer, is a speaker for Bayer and Janssen, and is the inventor of patent W02018136792A1 “Inhibitors of the n-terminal domain of the androgen receptor”.

Figures

Figure 1
Figure 1
The original VA STARPORT study schema (a) and the current amended STARPORT study schema that includes de novo patients and up to 10 metastases (b). ADT = androgen deprivation therapy; CRPC = castration-resistant prostate cancer; rPFS = radiographic progression-free survival; cPFS = clinical progression-free survival; FFILP = freedom from local progression; MFS = metastasis-free survival; PCSS = prostate cancer-specific survival; OS = overall survival. * Includes any form of molecular PET/CT imaging for prostate cancer. ¥ Standard systemic therapy will be determined by the treating physician and must be consistent with current NCCN guidelines. It can be delivered by using: (1.) ADT or (2.) Enhanced system therapy delivered by combining ADT with any chemotherapy or androgen receptor axis targeted agent. £ Metastasis-directed therapy can be delivered with surgery or radiation, and those with local recurrence will be treated with local therapy per standard of care.
Figure 2
Figure 2
Sites enrolling in VA STARPORT over the first phase of recruitment until all sites became active.
Figure 3
Figure 3
Algorithms for indications for PSMA PET/CT imaging and pathways for management.
See this image and copyright information in PMC

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