Prostate Cancer
Conditions
Keywords
[177Lu]Lu-PSMAI&T, Oligometastatic prostate cancer, Radical prostatectomy, Therapy toxicity
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.
Interventions
2 cycles of 5 GBq \[177Lu\]Lu-PSMA I&T at 6-week intervals prior radical prostatectomy for patients with oligometastatic prostate cancer
Sponsors
Medical University of Vienna
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective single-center phase II study
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent adverse events [Safety and Tolerability] of neoadjuvant PSMA-RLT and radical prostatectomy | 12 months | Using the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Furthermore, regular estimation of patient's ability to perform their usual everyday activities using Karnofsky performance status scale that ranges between a maximum of 100 percent (no restrictions) and 0 percent (death) and Eastern Cooperative Oncology Group Status scale that ranges from 0 (complete health) to 5 (death). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Imaging response and stability to neoadjuvant PSMA-RLT and radical prostatectomy | 24 months | in terms of disappearance of PSMA-avid lesions and/or size regression of the metastatic lymph nodes evaluated based on response evaluation criteria of solid tumor (RECIST) version 1.1. |
| Any therapy- and androgen deprivation therapy-free survival after radical prostatectomy, | 24 months | estimate the time until the start of any therapy- and androgen deprivation therapy |
| Estimate time to castration-resistant prostate cancer | 24 months | estimate the time until no PSA response in terms of PSA decline to androgen deprivation therapy |
| PSA response to neoadjuvant PSMA-RLT and radical prostatectomy | 24 months | in term of PSA decline of ≥ 50% from baseline value |
| Quantification of circulating free tumor DNA (ctDNA) | 24 months | enumeration of circulating tumor cells (CTCs) during the study period, molecular changes measured in liquid biopsy markers and tissue specimens following PSMA-RLT and radical prostatectomy and during follow-up. |
| Assess quality of life under the systemic PSMA-RLT | 24 months | using the questionnaires: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) and Functional Assessment of Chronic Illness Therapy (FACT-P). |
| Evaluate pathologic response at radical prostatectomy | 24 months | measured as rates of pathologic complete response, minimal residual disease, pT3 disease, positive surgical margins, and lymph node metastasis. |
Countries
Austria
Contacts
Primary ContactSazan Rasul, PhD
Backup ContactShahrokh F. Shariat, Professor
Outcome results
None listed