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NCT Number: NCT06259123

Neoadjuvant PSMA-RLT in Oligometastatic PCa

Prospective single-center phase II study to evaluate the PSA, imaging and pathological response, as well as oncological outcomes of systemic radioligand therapy [177Lu]Lu-PSMAI&T (PSMA-RLT) in patients planned for radical prostatectomy (RP) for oligometastatic prostate cancer (PCa) diagnosed using [68Ga]Ga-PSMA-11 PET examination.

Ten patients with oligometastatic primary PCa diagnosed using [68Ga]Ga-PSMA-11 PET-CT/MRI imaging will be included in this study.

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Key information

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Oligometastatic PCa diagnosed using [68Ga]Ga-PSMA-11 imaging defined as M1a and/or M1b positive with ≤5 osseous metastases and/or M1c ≤3 lung metastases
  • 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 oncologic and medical conditions that result in patients not having a life expectancy of longer than the duration of the trial.
  • Nonmetastatic PCa on [68Ga]Ga-PSMA-11 imaging
  • >5 osseous metastases on [68Ga]Ga-PSMA-11 imaging
  • Visceral metastases, apart from lungs
  • Age > 75 years.
  • Ongoing or previous androgen deprivation therapy with agonist or antagonist therapies.
  • 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 of 5 GBq [177Lu]Lu-PSMA I&T at 6-week intervals prior radical prostatectomy for patients with oligometastatic prostate cancer

Other names: PSMA-RLT

Primary outcomes

  1. Incidence of treatment-emergent adverse events [Safety and Tolerability] of neoadjuvant PSMA-RLT and radical prostatectomy

    Time frame: 12 months

    Using the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Furthermore, regular estimation of patient's ability to perform their usual everyday activities using Karnofsky performance status scale that ranges between a maximum of 100 percent (no restrictions) and 0 percent (death) and Eastern Cooperative Oncology Group Status scale that ranges from 0 (complete health) to 5 (death).

Secondary outcomes

  1. PSA response to neoadjuvant PSMA-RLT and radical prostatectomy

    Time frame: 24 months

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

  2. Imaging response and stability to neoadjuvant PSMA-RLT and radical prostatectomy

    Time frame: 24 months

    in terms of disappearance of PSMA-avid lesions and/or size regression of the metastatic lymph nodes evaluated based on response evaluation criteria of solid tumor (RECIST) version 1.1.

  3. Any therapy- and androgen deprivation therapy-free survival after radical prostatectomy,

    Time frame: 24 months

    estimate the time until the start of any therapy- and androgen deprivation therapy

  4. Estimate time to castration-resistant prostate cancer

    Time frame: 24 months

    estimate the time until no PSA response in terms of PSA decline to androgen deprivation therapy

  5. Evaluate pathologic response at radical prostatectomy

    Time frame: 24 months

    measured as rates of pathologic complete response, minimal residual disease, pT3 disease, positive surgical margins, and lymph node metastasis.

  6. Quantification of circulating free tumor DNA (ctDNA)

    Time frame: 24 months

    enumeration of circulating tumor cells (CTCs) during the study period, molecular changes measured in liquid biopsy markers and tissue specimens following PSMA-RLT and radical prostatectomy and during follow-up.

  7. Assess quality of life under the systemic PSMA-RLT

    Time frame: 24 months

    using the questionnaires: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) and Functional Assessment of Chronic Illness Therapy (FACT-P).

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

Neoadjuvant [177Lu]Lu-PSMAI&T Radioligand Therapy (PSMA-RLT) for Patients With Oligometastatic Prostate Cancer Diagnosed Using [68Ga]Ga-PSMA-11 PET Imaging Followed by Radical Prostatectomy: A Prospective Phase II Pilot Study

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 14, 2024
Registry last updated
Feb 15, 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.

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