Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer

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.

Conditions

• Prostate Cancer
• Oligometastasis
• Oligorecurrence
• Recurrent Prostate Cancer
• Metastatic Prostate Cancer
• De Novo Prostate Cancer

Interventions

PROCEDURE

PET-directed Local Therapy using Surgery

Surgery will be used to treat metastases.

RADIATION

PET-directed Local Therapy using Radiation

Radiation therapy will be used to treat metastases. Radiation options include: 1. Stereotactic body radiotherapy (SBRT) using 1-10 fractions 2. Conventionally fractionated radiotherapy using elective nodal radiotherapy and a simultaneous integrated boost to involved nodes The selection of the form of metastasis-directed radiotherapy for each metastasis will be determined using shared decision-making between the treating physician and the Veteran.

OTHER

Salvage Local Therapy for locally recurrent disease

For Veterans who have a local recurrence in addition to oligorecurrent metastatic lesions, they will undergo salvage local therapy using brachytherapy, SBRT, surgery, cryotherapy or HIFU. The selection of modality of salvage local therapy will be determined using shared decision-making between the treating physician and Veteran.

DRUG

Goserelin, Histrelin, Leuprolide & Triptorelin

Androgen deprivation therapy (ADT) using an LHRH agonist

DRUG

ADT + Nilutamide, Flutamide, & Bicalutamide

ADT adding anti-androgen therapy to an LHRH agonist

DRUG

Degarelix & Relugolix

ADT using an LHRH Antagonist.

DRUG

ADT + Docetaxel +/- prednisone

Enhanced SST using chemohormonal therapy

DRUG

ADT + Abiraterone + Prednisone

Enhanced SST using Abiraterone + Prednisone

DRUG

ADT + Abiraterone + Methylprednisolone

Enhanced SST using Abiraterone + Methylprednisolone

DRUG

ADT + Apalutamide

Enhanced SST using ADT + Apalutamide

DRUG

ADT + Enzalutamide

Enhanced SST using ADT + Enzalutamide

RADIATION

Prostate-directed Radiation for De novo oligometastatic prostate cancer

Veterans in ARM 1 will receive prostate-directed RT only and NO treatment to any nodal or distant metastatic sites. Acceptable dose/fractionations include 55 Gy in 20 fractions and 36 Gy in 6 fractions. Veterans in ARM 2 should receive prostate-directed local therapy using radiotherapy or radical prostatectomy in addition to PET-directed local therapy to metastases.

Sponsors & Collaborators

• VA Office of Research and Development

  lead FED

Principal Investigators

• Abhishek Solanki, MD MS · Edward Hines Jr. VA Hospital, Hines, IL

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-07-01

Primary Completion

2026-09-30

Completion

2029-03-30

Countries

• United States

Study Locations