BridgeMD
New treatment option for Prostate Cancer
Official title Neoadjuvant PSMA-RLT in Oligometastatic PCa
ClinicalTrials.gov ID: NCT06259123
What this study is testing
What is [177Lu]Lu-PSMA I&T?
[177Lu]Lu-PSMA I&T is an investigational medicine, being studied as a potential treatment for prostate cancer.
Also referred to as PSMA-RLT.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Prospective single-center phase II study to evaluate the PSA, imaging and pathological response, as well as oncological outcomes of systemic radioligand therapy [177Lu]Lu-PSMAI\&T (PSMA-RLT) in patients planned for radical prostatectomy (RP) for oligometastatic prostate cancer (PCa) diagnosed using [68Ga]Ga-PSMA-11 PET examination. Ten patients with oligometastatic primary PCa diagnosed using [68Ga]Ga-PSMA-11 PET-CT/MRI imaging will be included in this study.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, men only
You may be able to join if
- 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...
- 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...
- Patients must be able to sign Informed Consent Form
You likely can't join if
- Concomitant participation in any other treatment 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.
See the full eligibility 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
- Concomitant participation in any other treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Vienna, Austria
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, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vienna, Austria. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.