PSMA-RLT in Biochemically Recurrent PCa

Launched by MEDICAL UNIVERSITY OF VIENNA · Jan 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called PSMA-Radioligand Therapy (PSMA-RLT) for men with recurrent prostate cancer, specifically for those who have a rise in a blood test called PSA after surgery or radiation therapy. The trial aims to see how effective this treatment is for patients who have a specific type of recurrence, known as biochemical recurrence, where the PSA level is above a certain point but there is no evidence of cancer returning to the same area. Participants will receive two cycles of this treatment, spaced six weeks apart.

To be eligible for this trial, participants must be men aged 65 to 74 who have had a rise in their PSA levels after previous treatments and have not received any hormonal therapy in the last year. They should also be able to walk and perform daily activities without much help and have adequate kidney and blood function. During the trial, participants will undergo monitoring and assessments to evaluate the treatment's effects. It's important to note that those with serious other health conditions or who are participating in other clinical trials may not qualify.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Patients with biochemical recurrence after radical prostatectomy and radiotherapy with a PSA doubling-time (DT) of ≤ 12 months.
• • No hormonal therapy within the last 12 months or recovered testosterone levels.
• • PSMA PET negative result for local recurrence; presence of distant metastases is allowed: (cN0, cM0/cM1).
• • 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 oncological and medical conditions that result in patients not having a life expectancy of longer than one year.
• • 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.