New targeted treatment for advanced prostate cancer using a radioactive compound

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates a novel treatment for metastatic castration-resistant prostate cancer (mCRPC) using a new PSMA ligand radiolabelled with terbium-161. The study is divided into two phases: the first compares the new treatment to an existing one at low doses, while the second aims to identify the optimal dose of the new treatment that maximizes benefits and minimizes side effects. The trial also evaluates various prostate cancer diagnostic methods to enhance treatment efficacy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Consent form signed
* Male patients with age \> 18 years
* Clinical indication for RLT with 177Lu-PSMA-I\&T (progressive PSMA-positive mCRPC patients after androgen receptor signalling pathway inhibitor and taxan-based chemotherapy or patient unfit for chemotherapy)
* Patients will be included in Phase Ia while being under active therapy with 177Lu-PSMA-I\&T (SoC) and after they have completed the first two cycles of 177Lu-PSMA-I\&T RLT
* At least 3 measurable tumours on PSMA PET/CT (\>1.5 cm) with sufficiently intense PSMA uptake (SUVmax\>20)
* ECOG Performance status: 0-1
* Blood parameters: a) Leucocytes ≥ 3 G/L; b) Haemoglobin ≥ 100 g/L; c) Thrombocytes ≥ 100 G/L
* Estimated glomerular filtration rate (eGFR) \> 45 ml/min
* Albumin \> 25 g/L
* ALT, AST, AP: ≤ 5 times upper standard value
* Bilirubin ≤ 2 times upper standard value
* For male patients who are not surgically sterilized (orchiectomy or vasectomy), appropriate contraceptive measures must be taken during RLT and until 4 months after completion of RLT. As acceptable contraceptive count sexual abstinence or double contraceptive methods: hormonal contraceptive (oral, transdermal, implants or injections) in combination with barrier methods (spiral, condom, diaphragm)

Exclusion Criteria:

* Prior PSMA-targeted RLT (except for the 2 first cycles in Part Ia)
* PSMA-negative (or PSMA-negative / FDG-positive) disease
* Known intolerance against DOTA, DOTAGA, urea-based analogues or against any of the components/formulation of 177Lu-PSMA-I\&T or 161Tb-SibuDAB solutions.
* Ongoing infection at the screening visit or a serious infection in the past 4 weeks
* Administration of another investigational product in the last 60 days before Visit 1 Day 1
* Prior or planed administration of a therapeutic radiopharmaceutical during 8 half-lives of the used radio-pharmaceutical's radionuclide, also during the ongoing study
* Any extensive radiotherapy involving bone marrow over the last 3 months before inclusion to the study
* Chemotherapy in the last 4 weeks before inclusion
* Any uncontrolled significant medical, psychiatric or surgical condition (active infection, unstable angina pectoris, cardiac arrhythmia, poorly controlled hypertension, poorly controlled diabetes mellitus \[HbA1c ≥ 9%\], uncontrolled congestive heart disease, etc.) or laboratory findings that might jeopardize the patient's safety or that would limit compliance with the objectives and assessments of the study. Any mental conditions which prevent the patient from understanding the type, extent and possible consequences of the study and/or an uncooperative attitude from the patient.
* Current history of any malignancy other than prostate cancer within 5 years of enrolment except for fully resected non-melanoma skin cancer

Where it's running

• University Hospital Basel
  Basel, Switzerland Recruiting

Study contacts

• Principal investigator: Alin Chirindel, MD — University Hospital, Basel, Switzerland
• Study coordinator: Damian Wild, MD
• Email: damian.wild@usb.ch
• Phone: +41 61 328 66 83

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• GZ17-6.02 treatment for advanced prostate cancer after hormone therapy

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.