NCT06259123RecruitingPhase 2
Neoadjuvant PSMA-RLT in Oligometastatic PCa
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
Source: ClinicalTrials.gov · Last updated 15 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 25 Dec 2023
- Start date
- 1 Feb 2024
- Primary completion date
- Jan 2027
- Lead sponsor
- Medical University of Vienna
- Diseases
- Prostate cancer
- NCT number
- NCT06259123
- EudraCT number
- 2022-004115-92
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 10
- From 1 Feb 2024 to the primary completion date, Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Presence of clinically relevant somatic or psychiatric diseases that might interfere with the objectives and assessments of the study.
Age
- Age \> 75 years.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.