Clinical trial NCT06259123: Neoadjuvant PSMA-RLT in Oligometastatic PCa
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: [177Lu]Lu-PSMAI&T
Oligometastatic prostate cancer
Radical prostatectomy
Therapy toxicity
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective single-center phase II study
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion 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

Exclusion Criteria:

* 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.
* 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

Primary outcomes:
measure: Incidence of treatment-emergent adverse events [Safety and Tolerability] of neoadjuvant PSMA-RLT and radical prostatectomy
timeFrame: 12 months
Secondary outcomes:
measure: PSA response to neoadjuvant PSMA-RLT and radical prostatectomy
timeFrame: 24 months
measure: Imaging response and stability to neoadjuvant PSMA-RLT and radical prostatectomy
timeFrame: 24 months
measure: Any therapy- and androgen deprivation therapy-free survival after radical prostatectomy,
timeFrame: 24 months
measure: Estimate time to castration-resistant prostate cancer
timeFrame: 24 months
measure: Evaluate pathologic response at radical prostatectomy
timeFrame: 24 months
measure: Quantification of circulating free tumor DNA (ctDNA)
timeFrame: 24 months
measure: Assess quality of life under the systemic PSMA-RLT
timeFrame: 24 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References: