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
Key facts
- Where
- Uppsala, SvédországSee the site
- Phase
- 2. fázis
Where in Svédország
- Region UppsalaUppsala, SvédországToborzás még nem indult
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?
Trial details
- Who runs it
- Region Uppsala
- Trial code
- EU 2026-527110-23-00
- Record updated
- 2026. augusztus 12.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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.