PSMA-RLT in Biochemically Recurrent PCa

NCT ID: NCT06220188

Last Updated: 2024-02-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-15
• Study Completion Date: 2027-01-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Biochemical recurrent prostate cancer but not radio-morphological local recurrence

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

Group Type: EXPERIMENTAL

[177Lu]Lu-PSMA I&T

Intervention Type: 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

Interventions

[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

Intervention Type: DRUG

Other Intervention Names

PSMA-RLT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Sazan Rasul, MD, PhD

Physician and post-doctoral researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University of Vienna

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Sazan Rasul, PhD

Role: CONTACT

sazan.rasul@meduniwien.ac.at

004314040058742

Shahrokh F. Shariat, Professor

Role: CONTACT

shahrokh.shariat@meduniwien.ac.at

004314040026150

Facility Contacts

Sazan Rasul, PhD

Role: primary

sazan.rasul@meduniwien.ac.at

014040058742

Other Identifiers

2022-003713-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1938/2022

Identifier Type: -

Identifier Source: org_study_id