Health TrialsbyHealthPanel

Outcomes of Local Treatment for Oligometastatic Prostate Cancer Diagnosed Using PSMA PET Imaging: OLIGOMET Study

ConditionsProstate Cancer MetastaticProstate Cancer Metastatic to BoneProstate CancerProstate NeoplasmOligometastatic DiseaseOligometastasis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-80
SponsorMedical University of Vienna

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Oligometastatic prostate cancer diagnosed using PSMA PET defined as cM1a and/or cM1b with ≤5 osseous metastases and/or M1c with ≤3 lung lesions, with or without cN positivity.

Oligometastatic prostate cancer treated with primary local therapy such as radical prostatectomy or radiation therapy.

Any Gleason Score, any cT stage, any PSA

Disqualifiers

Visceral metastases (apart from lungs).

Neoadjuvant therapy prior to first PSMA PET.

Non-metastatic prostate cancer.

Patients who did not undergo imaging before local treatment.

Trial population

Oligometastatic prostate cancer patients treated with local therapy across Europe.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Radical prostatectomy

    Procedure/Surgery

    Removal of the prostate and seminal vesicles.

  • Prostate irradiation

    Radiation

    Radiation therapy of the prostate.

  • Surgical metastasectomy

    Procedure/Surgery

    Surgical removal of metastases.

  • Irradiation of metastases

    Radiation

    Radiation therapy of metastases.

  • Abiraterone acetate

    Drug

    Administered as part of multimodal treatment for oligometastatic prostate cancer

  • Enzalutamide

    Drug

    Administered as part of multimodal treatment for oligometastatic prostate cancer

  • Darolutamide

    Drug

    Administered as part of multimodal treatment for oligometastatic prostate cancer

  • Apalutamide

    Drug

    Administered as part of multimodal treatment for oligometastatic prostate cancer

  • Docetaxel

    Drug

    Administered as part of multimodal treatment for oligometastatic prostate cancer

  • Lutetium-PSMA

    Drug

    Administered as part of multimodal treatment for oligometastatic prostate cancer

  • Androgen deprivation treatment

    Drug

    Administered as part of multimodal treatment for oligometastatic prostate cancer

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
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
2

Clinical progression-free survival (cPFS)

Defined as new prostate cancer-related symptom, radiographic progression, initiation of new treatment, or death.

Time frame
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
3

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).

Time frame
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

1

Local therapy complications

Local therapy complications are assessed using Clavien-Dindo classification for radical prostatectomy and RTOG/EORTC Radiation Toxicity Grading for radiation therapy.

Time frame
From the time of local therapy to 30 days after treatment.
2

Pathological response to systemic therapy

Change of pathological stage

Time frame
Measured immediately after the surgery
3

Imaging response to systemic therapy

Defined as prostate cancer downstaging and/or decrease in number of metastasis lesions due to the effect of systemic therapy. Time Frame: Measured from the administration of systemic treatment until the end of treatment, assessed up to 100 months

Time frame
Measured from the administration of systemic treatment until the end of treatment, assessed up to 100 months
4

Functional outcomes - continence

Defined as continence rate (no incontinence 0 pads/24h, mild 1 pads/24h, moderate 2-3 pads/24h, severe \>3 pads/24h).

Time frame
6 months, 1, 2, and 3 years after local therapy.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of Vienna

Lead sponsor

IRCCS Ospedale San Raffaele

Collaborator

University Hospital of Cologne

Collaborator

St. Antonius Hospital

Collaborator

Istituto Europeo di Oncologia

Collaborator

University Hospital, Udine, Italy

Collaborator

Azienda Ospedaliera San Giovanni Battista

Collaborator

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice

Collaborator

Lund University

Collaborator

Medical University of Warsaw

Collaborator

Ziekenhuis Netwerk Antwerpen (ZNA)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: