Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04787744
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2021-02-25
Brief Title:
Veterans Affairs Seamless Phase IIIII Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Veterans Affairs Seamless Phase IIIII Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for OligoRecurrenT Prostate Cancer VA STARPORT
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VA STARPORT
Brief Summary:
This is a prospective open-label multi-center seamless phase II to phase III randomized clinical trial designed to compare SST with or without PET-directed local therapy in improving the castration-resistant prostate cancer-free survival CRPC-free survival for Veterans with oligometastatic prostate cancer Oligometastasis will be defined as 1-10 sites of metastatic disease based on the clinical determination of the LSI which incorporates all imaging clinical and pathologic data available
Detailed Description:
Prostate Cancer is the most commonly diagnosed cancer among Veterans comprising 30 of new cancer diagnoses in the VA Eighty-five percent of men present with localized prostate cancer which is typically treated with active surveillance or curative local therapy using surgery or radiation therapy Unfortunately twenty percent of Veterans undergoing curative local therapy will develop metastatic recurrence These men typically receive palliative systemic hormonal therapy to control their disease Despite this over half of men will have cancer progression within 1-2 years and half will die within 5 years
Two diverging paradigms have been studied in recent years to improve the survival of men with recurrent metastatic prostate cancer First a subset of patients has oligometastatic disease These patients are hypothesized to have an intermediate clinical state in which ablative local therapy with surgery or radiation to all metastatic sites of disease metastasis-directed therapy MDT can lead to durable disease control and potentially cure in select patients Recent Phase II randomized trials have demonstrated improved long-term progression-free survival with MDT in the absence of systemic therapy
Yet 75 of patients receiving MDT for oligometastatic cancer develop progression in new areas arguing that systemic therapy is needed to treat occult metastases This is supported by data demonstrating that earlier palliative hormonal therapy is associated with improved survival In fact the second approach that has been studied in recent years is whether escalating hormonal therapy by adding novel androgen receptor axis targeted agents or chemotherapy improves outcomes in men with metastatic prostate cancer Multiple phase III randomized trials demonstrate that escalating hormonal therapy with these novel therapeutic agents improves progression-free survival and overall survival dramatically Therefore these agents have been integrated as an option into todays standard systemic therapy SST for metastatic prostate cancer
Given the promise of MDT to induce long-term cancer control and the effectiveness of SST to prevent further cancer progression there is an urgent need to determine whether adding MDT to SST improves disease outcomes further Additionally prior studies have excluded patients with local recurrence However these comprise a large proportion of Veterans with recurrent oligometastatic prostate cancer The primary goal of our study is to determine if adding PET-directed local therapy MDT and treatment of primary tumor de novo or primary tumor local recurrence on PETCT if applicable improves disease control compared to SST alone in Veterans with oligometastatic prostate cancer This is a multi-institutional phase IIIII randomized trial comparing SST with or without PET-directed local therapy Other goals of the study are to determine any differences in patterns of cancer progression survival and quality of life We also will determine if certain mutations present in tumor DNA can predict if Veterans will benefit from PET-directed local therapy
Two diverging paradigms have been studied in recent years to improve the survival of men with recurrent metastatic prostate cancer First a subset of patients has oligometastatic disease These patients are hypothesized to have an intermediate clinical state in which ablative local therapy with surgery or radiation to all metastatic sites of disease metastasis-directed therapy MDT can lead to durable disease control and potentially cure in select patients Recent Phase II randomized trials have demonstrated improved long-term progression-free survival with MDT in the absence of systemic therapy
Yet 75 of patients receiving MDT for oligometastatic cancer develop progression in new areas arguing that systemic therapy is needed to treat occult metastases This is supported by data demonstrating that earlier palliative hormonal therapy is associated with improved survival In fact the second approach that has been studied in recent years is whether escalating hormonal therapy by adding novel androgen receptor axis targeted agents or chemotherapy improves outcomes in men with metastatic prostate cancer Multiple phase III randomized trials demonstrate that escalating hormonal therapy with these novel therapeutic agents improves progression-free survival and overall survival dramatically Therefore these agents have been integrated as an option into todays standard systemic therapy SST for metastatic prostate cancer
Given the promise of MDT to induce long-term cancer control and the effectiveness of SST to prevent further cancer progression there is an urgent need to determine whether adding MDT to SST improves disease outcomes further Additionally prior studies have excluded patients with local recurrence However these comprise a large proportion of Veterans with recurrent oligometastatic prostate cancer The primary goal of our study is to determine if adding PET-directed local therapy MDT and treatment of primary tumor de novo or primary tumor local recurrence on PETCT if applicable improves disease control compared to SST alone in Veterans with oligometastatic prostate cancer This is a multi-institutional phase IIIII randomized trial comparing SST with or without PET-directed local therapy Other goals of the study are to determine any differences in patterns of cancer progression survival and quality of life We also will determine if certain mutations present in tumor DNA can predict if Veterans will benefit from PET-directed local therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CX002277-01 | OTHER_GRANT | VA Clinical Science Research Development | None |