177Lu-PSMA versus SBRT, a post hoc study

Lutetium-177-PSMA versus stereotactic ablative radiotherapy in oligo-metastatic hormone sensitive prostate cancer - Lutetium-177-PSMA versus stereotactic ablative radiotherapy in oligo-metastatic hormone sensitive prostate cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON57993

Enrollment

130

Registered

2025-09-15

Start date

2026-01-01

Completion date

Unknown

Last updated

2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer

Interventions

177Lu-PSMA-617 or stereotactic radiotherapy

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Histopathology proven prostate cancer One to five positive metastases on 18F-PSMA PET/CT in bones and/or lymph nodes. (Preferably) one lesion with SUVmax > 15. Partial volume correction is allowed. Biochemical recurrence (PSA > 1.0 ug/l)PSA doubling time of < 6 months. Serum PSA progression is defined as 2 consecutive rising PSA values measured at least 1 week apart. The minimal start value is 0.2 ug/l.No prior hormonal therapy (exception: in case of adjuvant treatment during external beam radiotherapyEastern Cooperative Oncology Group (ECOG): 0-1

Exclusion criteria

Exclusion criteria: Not included in the clinical (Bullseye) trial or the prospective registry for stereotactic ablative radiotherapy

Design outcomes

Primary

Measure	Time frame
To compare the androgen deprivation free survival in months of patients that received 177Lu-PSMA-617 versus SBRT.	—

Secondary

Measure	Time frame
Time to next anti-cancer therapy (TTNT), metastasis directed treatments or systemic therapyTo compare time until castration resistant prostate cancer (CR-PFS)To compare the overall survival (OS)To compare PSA progression free survival (PSA-PFS). PSA progression defined by Phoenix criteria of 2 ng/mL or more above the nadir (lowest PSA level after treatment). Radiological progression free survival (rPFS) based on PSMA PET/CT or CTTo compare the PSA response between 177Lu-PSMA-617 vs SBRT in terms of the percentage patients with a complete response (PSA < 0.1 ug/L) and the fraction of patients that had a >50% drop in PSA.	—

Measure

Time frame

Time to next anti-cancer therapy (TTNT), metastasis directed treatments or systemic therapyTo compare time until castration resistant prostate cancer (CR-PFS)To compare the overall survival (OS)To compare PSA progression free survival (PSA-PFS). PSA progression defined by Phoenix criteria of 2 ng/mL or more above the nadir (lowest PSA level after treatment). Radiological progression free survival (rPFS) based on PSMA PET/CT or CTTo compare the PSA response between 177Lu-PSMA-617 vs SBRT in terms of the percentage patients with a complete response (PSA < 0.1 ug/L) and the fraction of patients that had a >50% drop in PSA. 

—

Countries

Netherlands

Contacts

Public ContactBM Privé

Radboud Universitair Medisch Centrum

bastiaan.prive@radboudumc.nl0615569954

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)