Preoperative [177Lu]Lu-PSMAI&T radioligand therapy (PSMA-RLT) for patients with oligometastatic prostatecancer diagnosed using [68Ga]Ga-PSMA-11 PET imaging followed by radical prostatectomy: A Prospective Phase II Study

Phase 1

• Conditions: Prostate Cancer; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2022-004115-92-AT
• Lead Sponsor: Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-31
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

- Patients must be adults between 18 and 75 years of age.
- 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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
- more than 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified