PSMA-RLT in Biochemically Recurrent PCa

NCT06220188 | Recruiting Phase 2

• 2 other identifiers: 1938/20222022-003713-11
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer Recurrent

Keywords

[177Lu]Lu-PSMA I&T; PSMA-radioligand therapy; Biochemical recurrence; Prostate cancer; PSA value

Outcome Measures

Primary Outcomes (2)

• PSA response

  in term of PSA decline of ≥ 50% from baseline value

  12 months

• 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 Outcomes (5)

• Time to PSA value progression

  18 months

• androgen deprivation therapy- and other treatment-free survival

  18 months

• Evaluation of life quality of the treated patients

  18 months

• Assess time to imaging progression

  18 months

• Quantification of circulating free tumor DNA

  18 months

Study Arms (1)

Biochemical recurrent prostate cancer but not radio-morphological local recurrence

EXPERIMENTAL

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

Drug: [177Lu]Lu-PSMA I&T

Interventions

[177Lu]Lu-PSMA I&T DRUG

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

Also known as: PSMA-RLT

Biochemical recurrent prostate cancer but not radio-morphological local recurrence

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Sazan Rasul, PhD

CONTACT

004314040058742; sazan.rasul@meduniwien.ac.at

Shahrokh F. Shariat, Professor

CONTACT

004314040026150; shahrokh.shariat@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician and post-doctoral researcher

Model Details: Prospective single-center one-arm phase II study

Study Record Dates

• First Submitted: December 25, 2023
• First Posted: January 23, 2024
• Study Start: January 15, 2024
• Primary Completion: June 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 13, 2024

Record last verified: 2024-02

Locations

AU (1)