MDRT in Prostate Cancer Treated With Long-term Androgen Deprivation Therapy in the STAMPEDE Trial (METANOVA)

Launched by CASE COMPREHENSIVE CANCER CENTER · Nov 21, 2023

Keywords

ClinConnect Summary

The MDRT in Prostate Cancer study, part of the STAMPEDE trial, is exploring whether a type of radiation therapy, called metastasis-directed radiotherapy (MDRT), can improve treatment outcomes for men diagnosed with metastatic prostate cancer. This trial is comparing the standard treatment of hormone therapy and prostate radiation to the same treatment plus MDRT to targeted areas where the cancer has spread. Participants will receive hormone therapy for 12 months, and some may also have surgery to remove the prostate. The study seeks to enroll men aged 18 and older who have recently been diagnosed with prostate cancer that has spread but have not yet received treatment.

Eligible participants are those with clear signs of prostate cancer spread, confirmed by imaging tests, and who are generally healthy enough to undergo treatment. During the study, participants will be closely monitored for about a year, with follow-ups lasting up to five years. They may also be asked to provide tissue samples for research. This trial is a chance to potentially improve how metastatic prostate cancer is managed, giving patients and their families hope for better outcomes.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Participant must be ≥ 18 years of age.
• • Participant must have an ECOG performance status ≤ 1.
• • Histologic confirmation of prostate adenocarcinoma of the prostate gland, with evidence of metastasis on imaging by conventional imaging (MRI, CT, or 99mTc bone scan) or PSMA PET/CT. Biopsy of sites of metastasis is strongly encouraged, but not required.
• • There must be at least 10-15 unstained slides from 2 cores of the highest tumor cellularity available.
• • Newly diagnosed disease with no prior treatment(surgery, radiation or systemic treatment, ie hormone therapy or chemotherapy) to the primary disease.
• • Participants may have started LHRH agonist or antagonist therapy, and/or androgen receptor signaling inhibitor (ARSI) as long as it was not started more than 30 days before the participant is enrolled on this study.
• • In participants who undergo only conventional imaging, oligometastatic disease is defined as 1-5 discrete metastatic sites in the bone and/or extra-pelvic lymph node (LN) stations.
• • Extra-pelvic LN stations are superior to the regional/pelvic LN stations. Pelvic LN stations commence at the bifurcation of the aorta and bifurcation of the proximal inferior vena cava to the common iliac veins.
• • Radiographic criteria for a LN to be considered a metastatic focus is defined as short-axis diameter in the axial plane of ≥ 1.0 cm, with irregular border and/or heterogeneous morphology
• • In participants who undergo PSMA PET/CT (in the presence or absence of conventional imaging), oligometastatic disease is defined as 1-10 PSMA avid bone lesions and/or extra-pelvic LN stations. The MI-RADS reporting system will be followed to guide PSMA PET interpretation
• * In participants extra-pelvic nodal (M1a) disease only by PSMA PET/CT and M0 by conventional imaging (i.e. extra-pelvic LN did not meet size criteria by CT), participant must meet 2 of 3 following criteria in order to be eligible:
• • 1. PSA ≥ 40
• • 2. Evidence of cN1 disease (pelvic LN)
• • 3. Decipher score ≥ 0.89
• • Adequate organ and marrow function to receive treatment per treating physician
• • Medically fit for treatment and agreeable to follow-up.
• • Ability to understand and the willingness to sign a written informed consent.
• Exclusion Criteria:
• Participants with the presence of any of the following:
• • Castration resistant prostate cancer (CRPC).
• • Evidence of visceral or intracranial metastases.
• • Participant receiving any other investigational agents for cancer.
• • Participant is participating in a concurrent treatment protocol for cancer.
• • Unable to lie flat during or tolerate PET/MRI, PET/CT or SBRT.
• • Prior definitive treatment to the primary prostate cancer or pelvis.
• • Participant with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes (HgA1c \> 10), active pituitary or adrenal dysfunction, or psychiatric illness/social situations that would limit compliance with study requirements
• • History of another active malignancy within the previous 2 years, except for non-melanoma skin cancer, non-muscle invasive bladder cancer, or a malignancy that is considered cured with minimal risk of recurrence
• • Active Crohn's disease or ulcerative colitis despite medical management.
• • Refusal to sign informed consent.
• • Any condition that in the opinion of the investigator would preclude participation in this study