Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06220188

PSMA-RLT in Biochemically Recurrent PCa

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Prostate Cancer Recurrent Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Medical University of Vienna

Vienna, 1090, Austria

Location status: Recruiting

Location contact

Pawel Rajwa, MD

SUB_INVESTIGATOR

Sazan Rasul, PhD

CONTACT

[email protected]

014040058742

Sazan Rasul, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

[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

Other names: PSMA-RLT

Primary outcomes

  1. PSA response

    Time frame: 12 months

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

  2. Emergence of therapy toxicity

    Time frame: 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.

Secondary outcomes

  1. Time to PSA value progression

    Time frame: 18 months

    to evaluate progression free survival

  2. androgen deprivation therapy- and other treatment-free survival

    Time frame: 18 months

    analyze the time until the start of androgen deprivation therapy

  3. Evaluation of life quality of the treated patients

    Time frame: 18 months

    Using the questionnaires: FACT-P, EORTC QLQ

  4. Assess time to imaging progression

    Time frame: 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.

  5. Quantification of circulating free tumor DNA

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sazan Rasul, PhD

CONTACT

[email protected]

004314040058742

Shahrokh F. Shariat, Professor

CONTACT

[email protected]

004314040026150

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jan 23, 2024
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.