Neoadjuvant PSMA-RLT in Oligometastatic PCa

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06259123
• Other study ID #: 1944/2022
• Secondary ID: 2022-004115-92
• Status: Recruiting
• Phase: Phase 2
• Start date: February 1, 2024
• Est. completion date: June 2027

Study information

• Verified date: February 2024
• Source: Medical University of Vienna
• Contact: Sazan Rasul, PhD
• Phone: 004314040058742
• Email: sazan.rasul[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• [177Lu]Lu-PSMA I&T
2 cycles of 5 GBq [177Lu]Lu-PSMA I&T at 6-week intervals prior radical prostatectomy for patients with oligometastatic prostate cancer

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events [Safety and Tolerability] of neoadjuvant PSMA-RLT and radical prostatectomy	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).	12 months
Secondary	PSA response to neoadjuvant PSMA-RLT and radical prostatectomy	in term of PSA decline of = 50% from baseline value	24 months
Secondary	Imaging response and stability to neoadjuvant PSMA-RLT and radical prostatectomy	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.	24 months
Secondary	Any therapy- and androgen deprivation therapy-free survival after radical prostatectomy,	estimate the time until the start of any therapy- and androgen deprivation therapy	24 months
Secondary	Estimate time to castration-resistant prostate cancer	estimate the time until no PSA response in terms of PSA decline to androgen deprivation therapy	24 months
Secondary	Evaluate pathologic response at radical prostatectomy	measured as rates of pathologic complete response, minimal residual disease, pT3 disease, positive surgical margins, and lymph node metastasis.	24 months
Secondary	Quantification of circulating free tumor DNA (ctDNA)	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.	24 months
Secondary	Assess quality of life under the systemic PSMA-RLT	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).	24 months