LEUPRORELIN ACETATE for Biochemical recurrence of prostate cancer | Oligometastatic prostate cancer (≤4 metastases)

Inclusion criteria

• {"criterion_text":"- Histologically proven initial diagnosis of adenocarcinoma of the Prostate.\n- Biochemical recurrence of prostate cancer following primary local prostate treatment (radical prostatectomy, primary radiotherapy or radical prostatectomy +/- prostate bed adjuvant salvage radiotherapy) according to the EAU guidelines 2018. BCR after surgery: PSA > O.lng/ml. BCR after radiotherapy: PSA nadir +2 ng/ml (after exclusion of possible bounce effect).\n- Maximum 4 lesions (bone + lymph nodes) in total, without evidence of viscerai metastases. a. Nodal relapse (NI) in the pelvis on PSMA-PET scan with a maximum of 4 positive lymph nodes. The upper limit of the pelvis is defined as the aortic bifurcation. b. Nodal relapse (Ml) on PSMA-PET scan above the aortic bifurcation with a maximum of 3 positive lymph nodes. c. Bone relapse on PSMA-PET scan with a maximum of 3 lesions.\n- Age > 18 years.\n- PSMA-PET/CT scan or PSMA-PET/MRI within 60 days prior to randomization.\n- PSA < 10 ng/ml.\n- In case of chronic use of finasteride the PSA value should be < 5 ng/ml.\n- WHO performance state 0-2.\n- DSigned informed consent prior to registration/randomization."}

Exclusion criteria

• {"criterion_text":"- Visceral metastases.\n- PSA => 10 ng/ml.\n- PSA-doubling time < 3 months.\n- ADT or chemotherapy for recurrent PCa.\n- Testosterone < 1.7 nmol/l.\n- Painful metastases needed pain medication.\n- Previous or concurrent invasive active cancers other than superficial non-melanoma skin cancers.\n- Inability to understand the information on trial-related topics, to give informed consent or to fill out QoL questionnaires."}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is the 2-year metastases progression free survival","definition_or_measurement_approach":"2-year metastases progression-free survival (MPFS). No further definition or measurement approach is provided in the CTIS record."}

Secondary endpoints

• {"endpoint_text":"- 3 years PSA progression.","definition_or_measurement_approach":"Not specified in the CTIS record."}
• {"endpoint_text":"- Start of 2nd line treatment.","definition_or_measurement_approach":"Not specified in the CTIS record."}
• {"endpoint_text":"- Start 2nd MDRT treatment for new (progressive) oligometastases.","definition_or_measurement_approach":"Not specified in the CTIS record."}
• {"endpoint_text":"- Acute and late toxicity (late toxicity up to 3 years).","definition_or_measurement_approach":"Not specified in the CTIS record."}
• {"endpoint_text":"- Clinical progression-free survival.","definition_or_measurement_approach":"Not specified in the CTIS record."}
• {"endpoint_text":"- Quality of life.","definition_or_measurement_approach":"Not specified in the CTIS record."}
• {"endpoint_text":"- Progression pattern.","definition_or_measurement_approach":"Not specified in the CTIS record."}
• {"endpoint_text":"- Time to start of palliative ADT.","definition_or_measurement_approach":"Not specified in the CTIS record."}
• {"endpoint_text":"- Time to castration-resistance.","definition_or_measurement_approach":"Not specified in the CTIS record."}
• {"endpoint_text":"- Disease-specific and overall survival.","definition_or_measurement_approach":"Not specified in the CTIS record."}
• {"endpoint_text":"- Sensitivity of the imaging modality (PSMA-PET/CT or PSMA-PET/MRI) for patients receiving MDRT.","definition_or_measurement_approach":"Not specified in the CTIS record."}
• {"endpoint_text":"- Predictive biomarkers.","definition_or_measurement_approach":"Not specified in the CTIS record."}

Netherlands

Earliest CTIS Part Ii Submission Date

22-07-2024

Latest Decision Or Authorization Date

29-07-2024

Processing Time Days

7

Number Of Sites

10

Number Of Participants

280

Primary sponsor

Full Name

Universitair Medisch Centrum Groningen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands