Trial · NCT05560659
Lu-PSMA for Oligometastatic Prostate Cancer Treated With STereotactic Ablative Radiotherapy
NCT05560659, Phase 2, Recruiting, Peter MacCallum Cancer Centre, Australia
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lu-PSMA for Oligometastatic Prostate Cancer Treated With STereotactic Ablative Radiotherapy. Trials, record NCT05560659. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05560659
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lu-PSMA for Oligometastatic Prostate Cancer Treated With STereotactic Ablative Radiotherapy
- NCT number
- NCT05560659
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 92 participants, estimated
- Lead sponsor
- Peter MacCallum Cancer Centre, Australia
- Conditions
- Oligometastatic Prostate Cancer
- Interventions
- 177Lu-PSMA
- First posted
- 2022-09-29
- Last updated
- 2026-11-09
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluate the (bPFS) of SABR alone and SABR + 177Lu-PSMA | Through study completion, up until 12 months after the last patient commences treatment | The biochemical progression free survival (bPFS) of SABR alone and SABR + 177Lu-prostate-specific membrane antigen (PSMA) in patients with oligometastatic prostate cancer undergoing PSMA positron emission tomography (PET) staging. |
| Secondary | The AEs according to CTCAE v5.0 | Through study completion, up until 4 months ± 10 days from the commencement of ADT following progression | The type, grade and relationship to treatment of AEs will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 5.0 |
| Secondary | The PSA-response rate | Through study completion, up until time of biochemical progression +/- 10 days | PSA response will be defined as a 50% or greater decrease in PSA from baseline to the lowest post-baseline PSA result |
| Secondary | The ADT-free survival | Through study completion, up until biochemical progression +/- 10 days | ADT-FS is defined as the time from randomisation to the date of initiation of androgen deprivation therapy or date of death due to any cause |
| Secondary | The pattern of recurrence on PSMA PET | Time of biochemical progression +/-10 days | Pattern of relapse will be evaluated on the PSMA PET at progression in relation to baseline PSMA PET, including: a) number of new sites of disease; b) location of new disease of disease (pelvic nodes, extra-pelvic nodes, bone, viscera); c) progression at prior sites (yes or no) |
| Secondary | The patient reported quality of life | From the date of randomisation to the date of progression | QoL will be assessed using the EORTC QLQC-30 and EQ-5D-5L questionnaires |
| Secondary | The MDT PFS | Time point after Cycle 2 (28 days follow up post Cycle 2) until biochemical progression | MDT PFS is defined as the time from first MDT after initial treatment to first documented subsequent disease progression (biochemical, or clinical using the same definition as the primary endpoint) or date of death, whichever comes first. Only patients who received MDT as the only treatment modality after initial treatment will be included. |
| Secondary | The overall survival | Time point post randomisation to the date of death from any cause | OS is defined as the time from randomisation to the date of death from any cause |
| Secondary | Healthcare costs associated with delivering the intervention and management of AEs | Through study completion, an average of 3 years | Health economic analysis is planned to assess the real-world cost-effectiveness and broader economic impact of using 177Lu-PSMA + SABR compared to SABR alone (if an effect is observed). Costs included in the analysis will focus on those relevant to the intervention (177Lu-PSMA) including treatment-related hospitalisations, clinic visits, PSMA PET scans, and associated medical service utilisation. Additionally, healthcare resource used and their associated costs including those associated with the complications arising from each study arm will be extracted from hospital administrative records and data collected during the trial (e.g., CTCAE v 5.0 Toxicity Record) and compared to provide an understanding of overall costs. |
| Secondary | The PET-PFS | Through study completion, from the date of randomisation to the date of radiological progression or death from any cause, whichever comes first. | PET-PFS is defined as the time from randomisation to the date of radiological progression on PSMA PET/CT scan or death due to any cause, whichever comes first. Patients alive without a rise in PSA will be censored at last PSA assessment |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05560659
GET https://conductscience.org/api/trials/v1/NCT05560659/registered