Radioligand Treatment Before Surgery for Prostate Cancer That Has Spread a Little
Tests lutetium-177 PSMA therapy before surgery in adults with prostate cancer spread to few sites.
Plain-language title generated from the registry record
Registry title: Neoadjuvant PSMA-RLT in Oligometastatic PCa
Key facts
- Where
- Vienna, AustriaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06259123, who can take part
Where in Austria
- Medical University of ViennaVienna, AustriaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Medical University of Vienna
- Trial code
- NCT06259123
- Record updated
- 15 February 2024
- Original description
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.Read full original descriptionShow less
Neoadjuvant [177Lu]Lu-PSMAI&T Radioligand Therapy (PSMA-RLT) for Patients With Oligometastatic Prostate Cancer Diagnosed Using [68Ga]Ga-PSMA-11 PET Imaging Followed by Radical Prostatectomy: A Prospective Phase II Pilot Study
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.
Inclusion: 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: 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; 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; Age > 75 years; Nonmetastatic PCa on [68Ga]Ga-PSMA-11 imaging; >5 osseous metastases on [68Ga]Ga-PSMA-11 imaging; Visceral metastases, apart from lungs; Complete urinary out-flow obstruction or severe unmanageable urinary incontinence.