FDG-PET-Guided Metastasis Directed Radiation Therapy for the Treatment of Metastatic Hormone Sensitive Prostate Cancer, The PRTY Trial

Metastatic Prostate Carcinoma Clinical Trial

Official title: A Randomized Open Label Phase II Trial of FDG-PET-Guided Metastasis Directed Therapy in Patients With Metastatic Hormone Sensitive Prostate Cancer: PRTY Trial: PET- Guided Radiotherapy Consolidation

Status Recruiting

Clinical Trial Summary

This phase II trial compares the effect of FDG-positron emission tomography (PET)-guided metastasis directed radiation therapy (MDRT) in combination with standard treatments to standard treatments alone in treating patients with prostate cancer that is sensitive to androgen-deprivation therapy (ADT) and has spread from where it first started (primary site) to other places in the body (metastatic). Prostate cancer is the second leading cause of cancer death among men in the United States, despite the approval of several life-prolonging treatments by the Food and Drug Administration. However, over the past 10 years, there have been significant improvements in prolonging the lives of those with metastatic hormone sensitive prostate cancer, specifically by adding treatments to standard therapy, such as ADT. More recently, trials have demonstrated a benefit of using radiotherapy (high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors) to delay the progression of cancer and prolong life for patients with metastatic disease. Imaging scans with FDG-PET may be able to identify cancer sites that remain active despite standard treatment. Giving MDRT plus standard treatment to patients with FDG-PET-identified cancer sites may work better than standard treatment alone in treating metastatic hormone sensitive prostate cancer.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To compare the progression free survival (PFS) between standard of care (SOC) + MDRT (Arm 1A) versus (vs) SOC alone (Arm 1B). (Cohort 1 [cytotoxic therapy cohort]) II. To compare the proportions of patients in Arm 2A vs Arm 2B who attain complete response (CR) 6 months after randomization. (Cohort 2 [non-cytotoxic therapy cohort])

SECONDARY OBJECTIVES:

I. To compare the radiographic progression-free survival (rPFS) between Arms 1A and 1B. (Cohort 1 [cytotoxic therapy cohort]) II. To determine the proportions of patients with metastatic hormone sensitive prostate cancer (mHSPC) who achieve a serum prostate-specific antigen (PSA) level < 4 ng/mL and < 0.01 ng/mL and compare them between Arm 1A and 1B. (Cohort 1 [cytotoxic therapy cohort]) III. To determine the proportion of patients with skeletal related events (SRE), and compare them between Arms 1A and 1B. (Cohort 1 [cytotoxic therapy cohort]) IV. To assess the safety and toxicity of MDRT during and following MDRT completion. (Cohort 1 [cytotoxic therapy cohort]) V. To determine the objective response rate (ORR), defined as the proportion of patients who experience a confirmed complete response (CR) or confirmed partial response (PR) on fludeoxyglucose F-18 (FDG)-PET-2, and to compare ORR between Arms 2A and 2B. (Cohort 2 [non-cytotoxic therapy cohort]) VI. To determine the progression-free survival (PFS) and radiographic progression-free survival (rPFS), and to compare between Arms 2A and 2B. (Cohort 2 [non-cytotoxic therapy cohort]) VII. To determine the proportions of patients with mHSPC who achieve a serum PSA level < 4 ng/mL and < 0.01 ng/mL (undetectable), and compare them between Arms 2A and 2B. (Cohort 2 [non-cytotoxic therapy cohort]) VIII. To determine the proportion of patients with skeletal related events (SRE), and compare them between Arms 2A and 2B. (Cohort 2 [non-cytotoxic therapy cohort]) IX. To assess the safety and toxicity of MDRT during and following MDRT completion. (Cohort 2 [non-cytotoxic therapy cohort])

EXPLORATORY OBJECTIVES:

I. To examine association between imaging features and progression free survival (Cohort 1) or likelihood of response (Cohort 2).

II. To determine the time to treatment discontinuation (TTD) in Cohort 1 Arm 1A, 1B, and 1C, and Cohort 2 Arms 2A, 2B and 2C.

OUTLINE: Patients undergoing cytotoxic chemotherapy are assigned to Cohort 1, while patients not undergoing cytotoxic chemotherapy are assigned to Cohort 2.

COHORT 1: Patients undergo an FDG-PET scan after 6 months of SOC cytotoxic chemotherapy + androgen deprivation therapy (ADT). Patients with PET-avid disease are randomized to Arm 1A or 1B. Patients without PET-avid disease are assigned to Arm 1C.

ARM 1A: Patients continue their SOC ADT and undergo MDRT to up to 5 disease sites in the absence of unacceptable toxicity. Patients also undergo computed tomography (CT) and bone scans throughout the trial.

ARM 1B: Patients continue their SOC ADT on study. Patients also undergo CT and bone scans throughout the trial.

ARM 1C: Patients continue their SOC ADT on study. Patients also undergo CT and bone scans throughout the trial.

COHORT 2: Patients undergo an FDG-PET scan after 6 months of SOC ADT. Patients with PET-avid disease are randomized to Arm 2A or 2B. Patients without PET-avid disease are assigned to Arm 2C.

ARM 2A: Patients continue their SOC ADT and undergo MDRT to up to 5 disease sites in the absence of unacceptable toxicity. Patients undergo an additional FDG-PET scan at 6 months. Patients also undergo CT and bone scans throughout the trial.

ARM 2B: Patients continue their SOC ADT on study and undergo an additional FDG-PET scan at 6 months. Patients also undergo CT and bone scans throughout the trial.

ARM 2C: Patients continue their SOC ADT on study and undergo an additional FDG-PET scan at 6 months. Patients also undergo CT and bone scans throughout the trial.

After completion of study treatment, patients are followed up at 3 months (Arms 1A, 1B, 2A, 2B only) and 6 months, and then every 6 months until 36 months. ;

Related Conditions & MeSH terms

• Carcinoma
• Castration-Sensitive Prostate Carcinoma
• Hypersensitivity
• Metastatic Prostate Carcinoma
• Prostatic Neoplasms
• Stage IVB Prostate Cancer AJCC v8

• NCT number: NCT06244004
• Study type: Interventional
• Source: Northwestern University
• Contact: Study Coordinator
• Phone: 13126959367
• Email: cancer@northwestern.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: February 18, 2024
• Completion date: February 18, 2028