PSMA-RLT in Biochemically Recurrent PCa

Phase 2

Recruiting

• Conditions: Prostate Cancer Recurrent
• Interventions: Drug: [177Lu]Lu-PSMA I&T

• Registration Number: NCT06220188
• Lead Sponsor: Medical University of Vienna

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-25
• Study Start: 2024-01-15
• Study First Submitted QC: 2024-01-21
• Study First Posted: 2024-01-23
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-10
• Last Update Posted: 2024-02-13
• Primary Completion: 2026-06
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 20

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biochemical recurrent prostate cancer but not radio-morphological local recurrence	[177Lu]Lu-PSMA I&T	Patients with prostate cancer and confirmed biochemical recurrence with PSA of ≥ 0.2 ng/ml after radical prostatectomy or PSA \> nadir + 2ng/ml after radiotherapy but not radio-morphological local recurrence after primary therapy with curative intent will receive systemic therapy with \[177Lu\]Lu-PSMAI\&T radioligand therapy

Primary Outcome Measures

Name	Time	Method
Emergence of therapy toxicity	12 months	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.
PSA response	12 months	in term of PSA decline of ≥ 50% from baseline value

Secondary Outcome Measures

Name	Time	Method
Time to PSA value progression	18 months	to evaluate progression free survival
androgen deprivation therapy- and other treatment-free survival	18 months	analyze the time until the start of androgen deprivation therapy
Evaluation of life quality of the treated patients	18 months	Using the questionnaires: FACT-P, EORTC QLQ
Assess time to imaging progression	18 months	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.
Quantification of circulating free tumor DNA	18 months	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.

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria