[177Lu]Lu-PSMAI&T radioligand therapy (PSMA-RLT) for patients with prostate cancer and biochemical but not radio-morphological local recurrence after primary therapy with curative intent: A Prospective Phase II Pilot Study
EU CTIS ID: 2024-519348-34-00
What this study is testing
Evaluate the prostate specific antigen (PSA) response to [177Lu]Lu-PSMAI&T-RLT. Assess therapy toxicity of systemic [177Lu]Lu-PSMAI&T-RLT.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients must be adults ≥ 18 years of age. • Patients with BCR primarily treated with RP and patients with BCR primarily treated with RT with a PSA doubling-time (PSADT) of ≤ 12months. • No hormonal therapy within the last 12 months and/or recovered testosterone levels. • [68Ga]Ga-PSMA-11 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.
You likely can't join if
- 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 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.