Neoadjuvant PSMA-RLT in Oligometastatic PCa

Launched by MEDICAL UNIVERSITY OF VIENNA · Feb 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called PSMA-RLT, which uses a special type of radiation to target prostate cancer that has spread to a few other areas in the body, known as oligometastatic prostate cancer. The goal is to see how well this treatment helps lower prostate-specific antigen (PSA) levels, improve imaging results, and ultimately benefit patients before they undergo surgery to remove the prostate. The study will include 10 male patients aged between 65 and 75 who have been diagnosed with this specific type of prostate cancer using advanced imaging techniques.

To be eligible for the trial, patients must have a limited number of cancer spread sites (no more than five in the bones or three in the lungs) and be in good overall health, meaning they can perform daily activities with little to no assistance. Participants will receive the PSMA-RLT treatment and will be monitored closely for their response to the therapy. It’s important for potential participants to know that they cannot be involved in other clinical trials or have certain health conditions that could interfere with the study. Overall, this trial aims to explore a promising treatment option for men facing this type of prostate cancer.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Oligometastatic PCa diagnosed using \[68Ga\]Ga-PSMA-11 imaging defined as M1a and/or M1b positive with ≤5 osseous metastases and/or M1c ≤3 lung metastases
• • Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
• • Patients must have adequate bone marrow reserve: WBC ≥1.5 x 109 /L, Platelets ≥100 x 109 /L and Haemoglobin ≥9 g/dL.
• • Patients must have adequate renal function with eGFR ≥ 50mL/min/1.73m2 using the Modification of Diet Renal Disease (MDRD) equation and an Albumin level of ≥2.5 g/dL.
• • Patients must be able to sign Informed Consent Form
• Exclusion Criteria:
• • Concomitant participation in any other interventional trial
• • Concurrent severe oncologic and medical conditions that result in patients not having a life expectancy of longer than the duration of the trial.
• • Nonmetastatic PCa on \[68Ga\]Ga-PSMA-11 imaging
• • \>5 osseous metastases on \[68Ga\]Ga-PSMA-11 imaging
• • Visceral metastases, apart from lungs
• • Age \> 75 years.
• • Ongoing or previous androgen deprivation therapy with agonist or antagonist therapies.
• • Presence of clinically relevant somatic or psychiatric diseases that might interfere with the objectives and assessments of the study.
• • Complete urinary out-flow obstruction or severe unmanageable urinary incontinence