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Not yet recruiting NCT05896371

A Phase 1/2 Study of Personalized PSMA Radiopharmaceutical Therapy

Phase I / Phase II Interventional Cancer Prostate Cancer Metastatic Cancer Metastatic Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 177Lu-PSMA-I&T - escalating renal absorbed dose, 177Lu-PSMA-I&T - recommended phase 2 regime.
Who it may be relevant to
Registry conditions: Cancer, Prostate Cancer, Metastatic Cancer, Metastatic Prostate Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

PROstate-specific Membrane Antigen DosImetry-Guided EndoradiotherapY: a Phase 1/2 Study of Personalized PSMA Radiopharmaceutical Therapy (PRODIGY-1)

Overview

The goal of this clinical trial is to study a personalized regime of lutetium-177 (177Lu) prostate-specific membrane antigen (PSMA) radiopharmaceutical therapy (RPT) in patients with progressive and/or symptomatic, inoperable PSMA-expressing cancers of prostatic or other origins. The main questions it aims to answer are: * To establish a dosimetry-based, personalized regime of 177Lu-PSMA * To report on the efficacy of personalized 177Lu-PSMA Participants (stratified by risk factors of toxicity) will receive up to 6 cycles of a personalized activity of 177Lu-PSMA based on renal dosimetry. In the phase 1, the prescribed absorbed dose to the kidney will be escalated, to determine the regime that will be administered in the phase 2. The best response within 12 months after the first cycle will be assessed. Salvage treatment of 3 cycles may be offered to responders after re-progression.

Interventions

  • Drug 177Lu-PSMA-I&T - escalating renal absorbed dose
    Personalized 177Lu-PSMA-I\&T injected activity
  • Drug 177Lu-PSMA-I&T - recommended phase 2 regime
    Personalized 177Lu-PSMA-I\&T injected activity

Primary outcome measures

  • Phase 1: Number of dose-limiting toxicities (DLTs) [Time frame: 12 weeks]
  • Phase 2: Overall response rate (ORR) [Time frame: Up to 12 months]
  • Phase 2: Biochemical response rate (PSA50) [Time frame: Up to 12 months]
Secondary outcome measures (7)
  • Frequency and grades of treatment-related adverse events (AEs) [Time frame: Up to 12 months]
  • Delayed AEs of particular interest [Time frame: Up to 5 years]
  • Phase 1: Overall response rate (ORR) [Time frame: Up to 12 months]
  • Phase 1: Biochemical response rate (PSA50) [Time frame: Up to 12 months]
  • Quality of life patient-reported outcome measures (PROMs) response rates [Time frame: Up to 12 months]
  • Progression-free survival (PFS) [Time frame: Up to 5 years]
  • Overall survival (OS) [Time frame: Up to 5 years]

Eligibility criteria

Inclusion criteria

  • >18 y.o. adults able to provide consent
  • Inoperable or metastatic PSMA-expressing cancer, with significant PSMA expression defined as uptake in at least one lesion that is superior to that of the liver on PSMA positron-emission tomography (PET) within 3 months prior to enrolment
  • Cancer progression documented within 3 months prior to enrolment as per the investigator's assessment, without initiation of another anti-cancer treatment since (excluding palliative radiation therapy to a minority of the tumor burden), unless that anti-cancer treatment was stopped prematurely because of intolerance
  • For participants with a cancer other than mCRPC, a recommendation from a multidisciplinary tumor board (MDT) in favor of PSMA RPT must be obtained

Exclusion criteria

  • Platelets < 50 x 106/L
  • Absolute neutrophil count (ANC) < 1.0 x 106/L
  • Eastern Cooperative Oncology Group (ECOG) 4 or prognosis < 3 months, for cancer-related or other serious medical conditions, as per investigator's assessment
  • Known presence of central nervous system metastasis at risk of complication, which cannot be adequately stabilized (e.g. radiotherapy or corticoid prophylaxis), as per investigator's assessment
  • Any condition that would limit the ability to comply with the study protocol, as per investigator's assessment
  • Pregnancy or breastfeeding (e.g. for female participants with non-prostate cancer)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05896371 · 2023-6822

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗