Frontlight ResearchEarly access
Not yet taking people in SwedenPhase 2
Tests radioligand therapy with 177Lu-PSMA I&T in advanced prostate cancer
Tests 177Lu-PSMA I&T, with doses adapted to each person, in prostate cancer.
Key facts
- Who runs it
- Region Uppsala
- Where
- Uppsala, SwedenSee the site
- Trial code
- Registry title
- A phase II, single arm two-phase, clinical study of individually adapted systemic radioligand therapy with 177Lu-PSMA I&T for patients with metastatic, castration-resistant prostate cancer
- Status
- Not yet recruiting
- Phase
- Phase 2
- People taking part
- 80 people, planned
- Started
- 1 Nov 2026
- Expected to end
- 31 Jan 2029
- Type of study
- Interventional
- Record updated
- 12 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with prostate cancer that has spread and no longer responds to hormone-lowering treatment. All must have PSMA-positive disease. They get 177Lu-PSMA I&T radioligand therapy.
- Age
- 18 years or older
- Sex
- Men only
- Disease stage
- Prostate adenocarcinoma that has spread (metastatic), castration resistant, PSMA-positive, with testosterone ≤ 1.7 nmol/L. The disease must be getting worse, and measurable bone or organ spread must be seen on PSMA-PET/CT.
- Earlier treatment
- At least one ARPI (such as enzalutamide or abiraterone) and one earlier taxane treatment, or not able to have taxane treatment. No earlier radiopharmaceutical treatment for prostate cancer.
- Biomarker or test result
- PSMA-positive tumour; serum testosterone ≤ 1.7 nmol/L
Main reasons for not taking part
- Earlier radiopharmaceutical treatment for prostate cancer
- Chemotherapy, immunotherapy, PARP inhibitor or other trial treatment at the same time
- Urinary tract blockage, uncontrollable urine leakage or marked hydronephrosis
- Brain metastases or symptomatic spinal cord compression
- Radiotherapy or chemotherapy within 2 months before the planned treatment
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- Histologically confirmed adenocarcinoma of the prostate
- PSMA-positive, castration resistant prostate cancer with serum testosterone ≤ 1.7 nmol/L
- At least one ARPI (such as enzalutamide or abiraterone), and one previous taxane treatment, or not eligible for taxane treatments
- Progressive disease defined as one of the following: a. New lesions or significant tumor growth on any of the following radiological scans; BS, CT, 18-DCFPyL-PSMA-PET (18F-PSMA) or 18F-PET/CT b. Rising PSA defined as: - Consecutive increase in PSA, determined by two separate measurements taken at least 1 week apart and confirmed by a third, and if necessary, measurement, - PSA ≥ 5 ng/mL and ≥ 25% above the previous nadir
- WHO/ECOG performance status 0-2. (See Appendix A)
- Patient must be ≥ 18 years of age
- Expected survival > 6 months
- Measurable bone or visceral metastasis confirmed with PSMA-PET/CT
Who cannot take part
- Prior treatment radiopharmaceutical agents for prostate cancer
- Concurrent cytotoxic chemotherapy, immunotherapy, other isotope treatment, PARP inhibitor, biological, or investigational therapy
- Previous or concurrent cancers other than basal, in situ, or squamous cell skin cancers, or superficial bladder cancer unless disease-free for ≥ 3 years
- Radiotherapy or chemotherapy within 2 months prior to planned treatment
- Major medical or psychiatric illness, which in the investigator’s opinion, would prevent completion of treatment and would interfere with follow-up
- Serious hematologic, renal or CNS illness that in the opinion of the investigator would preclude study participation
- Cardiovascular disease (severe symptomatic coronary artery disease, congenital heart failure, class 3 and 4 of the New York heart association functional classification, NYHA)
- Urinary tract obstruction, or uncontrollable urine incontinence, or marked hydronephrosis
- Superscan on bone scan
- Brain metastases, uncontrolled symptomatic or asymptomatic
- Symptomatic cord compression
Where in Sweden
- Region UppsalaUppsala, SwedenNot yet recruiting
About the trial
What the trial wants to find out
The primary objective of this study is to evaluate biochemical Progression Free Survival (bPFS) in patients with mCRPC after treatment with individually adapted doses of 177Lu-PSMA I&T.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- A phase II, single arm two-phase, clinical study of individually adapted systemic radioligand therapy with 177Lu-PSMA I&T for patients with metastatic, castration-resistant prostate cancer
- Plain-language title
- Tests radioligand therapy with 177Lu-PSMA I&T in advanced prostate cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 12 August 2026