Prostate Cancer Clinical Trial
— OLIGOMETOfficial title:
Outcomes of Local Treatment for Oligometastatic Prostate Cancer Diagnosed Using PSMA PET Imaging: OLIGOMET Study
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.
Status | Not yet recruiting |
Enrollment | 500 |
Est. completion date | December 31, 2031 |
Est. primary completion date | January 1, 2031 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Medical University of Vienna | Azienda Ospedaliera San Giovanni Battista, IRCCS Ospedale San Raffaele, Istituto Europeo di Oncologia, Lund University, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice, Medical University of Warsaw, St. Antonius Hospital, University Hospital of Cologne, University Hospital, Udine, Italy, Ziekenhuis Netwerk Antwerpen (ZNA) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Local therapy complications | Local therapy complications are assessed using Clavien-Dindo classification for radical prostatectomy and RTOG/EORTC Radiation Toxicity Grading for radiation therapy. | From the time of local therapy to 30 days after treatment. | |
Secondary | Pathological response to systemic therapy | Change of pathological stage | Measured immediately after the surgery | |
Secondary | 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 |
Measured from the administration of systemic treatment until the end of treatment, assessed up to 100 months | |
Secondary | 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). | 6 months, 1, 2, and 3 years after local therapy. | |
Secondary | Functional outcomes - potency | Defined as potency (potent ( IIEF-EF=>22), inpotent (IIEF-EF <22) | 6 months, 1, 2, and 3 years after local therapy. | |
Secondary | Cancer-specific survival | Time from oligometastasis diagnosis to death from prostate cancer. | From date of diagnosis until the date of death from prostate cancer, assessed up to 100 months | |
Secondary | Overall survival | Time from oligometastasis diagnosis to death of any cause. | From date of diagnosis until the date of death from any cause, assessed up to 100 months |
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