TRIPTORELIN for Acinar cell carcinoma of prostate

Inclusion criteria

• {"criterion_text":"- •\tAge 18-80 years old."}
• {"criterion_text":"- •\tProstate Volume less than 100cc"}
• {"criterion_text":"- •\tPSA must be dosed maximum 60 days before randomization"}
• {"criterion_text":"- •\tNo pathologic lymph nodes and distant metastasis on PET scan (fluorocholine or fluoroPSMA- galliumPSMA ) or CT scan+bone scan."}
• {"criterion_text":"- •\tHistological confirmation of prostate acinar adenocarcinoma with a minimum of 10 biopsy cores taken"}
• {"criterion_text":"- •\tProstate protocol MRI for local staging"}
• {"criterion_text":"- •\tPatients belonging to intermediate unfavorable group according to the D’Amico/NCCN risk group classification: o\t-Grade group 3 or/and o\t-2-3 risk factors for intermediate category (PSA 10-20 ng/ml/ Grade group 2-3/ cT2b-cT2c) or/and o\t-biopsy cores positive ≥50%"}
• {"criterion_text":"- •\tPatients belonging to a subclass of high risk group according to the D’Amico/NCCN risk group classification: o\t-ISUP group 4 (GS 4+4, excluding 3+5 and 5+3) or o\t-cT3a stage or o\tPSA>20 ng/ml"}
• {"criterion_text":"- •\tEastern Coooperative Oncology Group (ECOG) PS 0-2"}
• {"criterion_text":"- •\tAbility of the patient to understand and sign a written informed consent document"}
• {"criterion_text":"- •\tAbility and Willingness to comply with patients reported outcome questionnaires schedule during the study time"}
• {"criterion_text":"- •\tIPSS 0-15"}

Exclusion criteria

• {"criterion_text":"- •\tHistory of Malignant tumors in the previous 2 years excluding non melanoma cancers of the skin. If a patient presents an anamnesis of malignancy (excluding non melanoma skin cancers) it must be free from disease since 24 months at the time of enrollement. Patients affected by hematologic tumors in clinical-radiologic remission since at least 5 years after treatment or after follow-up only for which the prognosis is more than 10 years could be included in the trial after heamtologic consultation clearly declaring the prognosis. (chronic leucemia, phollicolar lymphoma, myelodisplastic syndromes)."}
• {"criterion_text":"- •\tControindication or hypersensitivity to the use of Triptoreline"}
• {"criterion_text":"- •\t5alpha reductase inhibitors not discontinued 4 weeks prior to randomization"}
• {"criterion_text":"- •\tHistory of bone fractures and fall"}
• {"criterion_text":"- •\tRisk factors for abnormal heart rhythms or QT prolongation."}
• {"criterion_text":"- •\tUse of concomitant medications that prolong the QT/QTc interval"}
• {"criterion_text":"- •\tPrevious prostate surgery other than TURP (at least 6 weeks prior to start of SBRT)."}
• {"criterion_text":"- •\tPrevious pelvic RT"}
• {"criterion_text":"- •\tPrior androgen deprivation therapy (excluding 5alpha reductase inhibitors)"}
• {"criterion_text":"- •\tAny prior active treatment for prostate cancer; patients on previous active surveillance are eligible if inclusion criteria are met"}
• {"criterion_text":"- •\tActive severe inflammatory bowel disease"}
• {"criterion_text":"- •\tBilateral hip prothesis or any implant that could seriously interfere with dosimetric calculations"}
• {"criterion_text":"- •\tAge >80 years."}
• {"criterion_text":"- •\tcT4a, cT3b or pelvic lymph node involvement"}

Primary endpoints

• {"endpoint_text":"- •\tTo determinate if there is improvement in biochemical Disease free survival (bDFS, defined as PSA elevation ≥ 2 ng/ml over Nadir, following the Phoenix criteria*) in patients treated with prostate SBRT + ADT (ARM A) compared to patients treated with SBRT alone (ARM B).","definition_or_measurement_approach":"bDFS defined in protocol as PSA elevation ≥ 2 ng/ml over Nadir, following the Phoenix criteria."}

Secondary endpoints

• {"endpoint_text":"- •\tDisease free survival (DFS, defined as evidence of biochemical, local, regional or distant relapse on imaging).","definition_or_measurement_approach":"DFS defined as evidence of biochemical, local, regional or distant relapse on imaging."}
• {"endpoint_text":"- •\tFreedom from local recurrence (FFLR, defined as evidence of in-field recurrence detected at imaging and/or Histologically proved)","definition_or_measurement_approach":"FFLR defined as evidence of in-field recurrence detected at imaging and/or histologically proven."}
• {"endpoint_text":"- •\tFreedom from regional recurrence (FFRR, defined as evidence of out-of field recurrence in the true pelvis as defined by TNM VIII criteria for regional node)","definition_or_measurement_approach":"FFRR defined as evidence of out-of-field recurrence in the true pelvis per TNM VIII criteria for regional node."}
• {"endpoint_text":"- •\tFreedom from distant metastasis (FFDM, defined as evidence of out of field recurrence that meets the criteria of M1 defined by TNM VIII)","definition_or_measurement_approach":"FFDM defined as evidence of out-of-field recurrence meeting M1 criteria of TNM VIII."}
• {"endpoint_text":"- •\tOverall Survival (OS, defined as death for any cause)","definition_or_measurement_approach":"OS defined as death from any cause."}

Italy

Earliest CTIS Part Ii Submission Date

05-12-2024

Latest Decision Or Authorization Date

24-07-2025

Processing Time Days

231

Number Of Sites

28

Number Of Participants

310

Primary sponsor

Full Name

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy

Third parties

• {"country":"Italy","full_name":"IPSEN","duties_or_roles":"Source of monetary support","organisation_type":""}