PSMA-RLT in Biochemically Recurrent PCa

Prostate Cancer Recurrent Clinical Trial

Official title:

[177Lu]Lu-PSMAI&T Radioligand Therapy (PSMA-RLT) for Patients With Prostate Cancer and Biochemical But Not Radio-morphological Local Recurrence After Primary Therapy With Curative Intent: A Prospective Phase II Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06220188
• Other study ID #: 1938/2022
• Secondary ID: 2022-003713-11
• Status: Recruiting
• Phase: Phase 2
• Start date: January 15, 2024
• Est. completion date: January 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 one-arm phase II study in patients with prostate cancer and confirmed biochemical recurrence (BCR) with PSA of ≥ 0.2 ng/ml after radical prostatectomy (RP) or PSA > nadir + 2ng/ml after radiotherapy (RT) but not radio-morphological local recurrence after primary therapy with curative intent receive systemic therapy with only 2 cycles of highly standardized (3 GBq in first cycle and 6 GBq in the second cycle) PSMA-RLT at 6-week intervals.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2027
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with biochemical recurrence after radical prostatectomy and radiotherapy with a PSA doubling-time (DT) of = 12 months.

• No hormonal therapy within the last 12 months or recovered testosterone levels.

• PSMA PET negative result for local recurrence; presence of distant metastases is allowed: (cN0, cM0/cM1).

• 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 oncological and medical conditions that result in patients not having a life expectancy of longer than one year.

• 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 Recurrent
• Prostatic Neoplasms

Intervention

Drug:
• [177Lu]Lu-PSMA I&T
2 cycles (3 GBq in first cycle and 6 GBq in the second cycle) of [177Lu]Lu-PSMAI&T radioligand therapy at 6-week intervals

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	PSA response	in term of PSA decline of = 50% from baseline value	12 months
Primary	Emergence of therapy toxicity	in terms of pathological (Grade 3) reduction of values of blood count (hemoglobin decreased <8.0 g/dL; <4.9 mmol/L; <80 g/L; platelet count decreased <50,000 - 25,000/mm3; <50.0 - 25.0 x 10e9 /L and white blood cell decreased <2000 - 1000/mm3; <2.0 - 1.0 x 10e9 /L. ), kidney (creatinine increased > 3.0 x baseline or >3.0 - 6.0 x upper limit of normal (UNL)) and liver functions (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and GGT increased >5.0 - 20.0 x ULN if baseline was normal or >5.0 - 20.0 x baseline if baseline was abnormal; albumin <2 g/dL or <20 g/L; bilirubin increased >3.0 - 10.0 x ULN if baseline was normal or >3.0 - 10.0 x baseline if baseline was abnormal and lactate dehydrogenase increased > ULN.), assessed by Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.	12 months
Secondary	Time to PSA value progression	to evaluate progression free survival	18 months
Secondary	androgen deprivation therapy- and other treatment-free survival	analyze the time until the start of androgen deprivation therapy	18 months
Secondary	Evaluation of life quality of the treated patients	Using the questionnaires: FACT-P, EORTC QLQ	18 months
Secondary	Assess time to imaging progression	In terms of appearance of new PSMA-avid lesions and/or size progression of the metastatic lymph nodes evaluated based on response evaluation criteria of solid tumor (RECIST) version 1.1.	18 months
Secondary	Quantification of circulating free tumor DNA	Quantification of circulating free tumor DNA (ctDNA), enumeration of circulating tumor cells (CTCs) before and following [177Lu]Lu-PSMAI&T-RLT and analyse molecular changes in liquid biopsy markers following [177Lu]Lu-PSMAI&T-RLT.	18 months