Brief Summary

PSMA-PET/CT or PSMA-PET/MRI are more accurate imaging modalities compared to CT/BS; in approximately 10-20% of high-risk patients diagnosed using conventional imaging PSMA-PET up-stages the disease. Therefore a substantial proportion of high-risk patients previously considered as non-metastatic are expected to be diagnosed with oligometastatic disease. While standard treatment pathways exist for patients with non-metastatic or oligometastatic disease confirmed using conventional imaging, less is known about the optimal management of patients with oligometastatic prostate cancer on PSMA-PET. Currently, data on the safety, effectiveness and oncologic outcomes of local therapies in oligometastatic patients diagnosed using PSMA-PET have been poorly reported so far. Thus, there is a need for a prospectively maintained database to collect real-world clinical data to produce high-quality research on the optimal management in oligometastatic prostate cancer who underwent PSMA-PET for primary staging and subsequent local therapy. This database will allow centers to retro- and prospectively collect data to facilitate analysis and assessment of the outcomes of oligometastatic patients managed with local therapy.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

500

participants targeted

Target at P75+ for all trials

Timeline

68mo left

Started May 2024

Longer than P75 for all trials

Status

not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

7.6 years study duration

Study Progress26%

May 2024Dec 2031

First Submitted

Initial submission to the registry

April 2, 2024

Completed

2 months until next milestone

First Posted

Study publicly available on registry

May 28, 2024

Completed

3 days until next milestone

Study Start

First participant enrolled

May 31, 2024

Completed

6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2031

Expected

12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2031

Last Updated

May 28, 2024

Status Verified

May 1, 2024

Enrollment Period

6.6 years

First QC Date

April 2, 2024

Last Update Submit

May 24, 2024

Conditions

Prostate Cancer Metastatic Prostate Cancer Metastatic to Bone Prostate Cancer Prostate Neoplasm Oligometastatic Disease Oligometastasis

Keywords

prostateoligometastaticoligometastasisoligometprostatectomyirradiationabirateroneenzalutamidedarolutamideapalutamideandrogen deprivation therapyADTdocetaxelPSMA PET

Outcome Measures

Primary Outcomes (3)

Radiographic progression-free survival (rPFS)
Defined as increase in size of existing lesion or appearance of new lesion (on any subsequent follow-up imaging modality used for baseline assessment), or death.
From date of diagnosis until the date of first documented radiographic progression or date of death from any cause, whichever came first, assessed up to 100 months
Clinical progression-free survival (cPFS)
Defined as new prostate cancer-related symptom, radiographic progression, initiation of new treatment, or death.
From date of diagnosis until the date of first documented clinical progression or date of death from any cause, whichever came first, assessed up to 100 months
Castration resistance-free survival (CRPC-FS)
Castration resistance is defined as: castrate serum testosterone \<50ng/dL or 1.7nmol/L, plus either biochemical progression (three consecutive rises in PSA at least one week apart resulting in two 50% increases over the nadir, and a PSA \> 2ng/mL) or radiographic progression (\> 2 new bone lesions or a new soft tissue lesion).
From date of diagnosis until the date of castration resistance or date of death from any cause, whichever came first, assessed up to 100 months

Secondary Outcomes (7)

Local therapy complications
From the time of local therapy to 30 days after treatment.
Pathological response to systemic therapy
Measured immediately after the surgery
Imaging response to systemic therapy
Measured from the administration of systemic treatment until the end of treatment, assessed up to 100 months
Functional outcomes - continence
6 months, 1, 2, and 3 years after local therapy.
Functional outcomes - potency
6 months, 1, 2, and 3 years after local therapy.
+2 more secondary outcomes

Interventions

Radical prostatectomyPROCEDURE

Removal of the prostate and seminal vesicles.

Prostate irradiationRADIATION

Radiation therapy of the prostate.

Surgical metastasectomyPROCEDURE

Surgical removal of metastases.

Irradiation of metastasesRADIATION

Radiation therapy of metastases.

Abiraterone acetateDRUG