Condition: Prostate Cancer, Malignant Neoplasm of Prostate, Secondary Malignant Neoplasm of Prostate

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06150417

Sponsor: Case Comprehensive Cancer Center

Phase: Phase 2

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

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 to the primary disease.
• Acceptable to have started LHRH agonist or antagonist therapy alone within the past 30 days prior to enrollment.
• 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.
• 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

View trial on ClinicalTrials.gov