prostate acinar adenocarcinoma MedDRA version: 20.0 Level: LLT Classification code 10007453 Term: Carcinoma of the prostate metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0 Level: LLT Classification code 10001201 Term: Adenocarcinoma of the prostate stage II System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0 Level: LLT Classification code 10007
Conditions
Interventions
Trade Name: Decapeptyl
Product Name: Decapeptyl
Product Code: [Decapeptyl]
Pharmaceutical Form: Powder and solvent for solution for injection/infusion
INN or Proposed INN: TRIPTORELINA
Current Sponsor
Sponsors
AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Age 18-80 years old. Histological confirmation of prostate acinar adenocarcinoma with a minimum of 10 biopsy cores taken Prostate protocol MRI for local staging Patients belonging to intermediate unfavorable group according to the D’Amico/NCCN risk group classification: o -Grade group 3 or/and o -2-3 risk factors for intermediate category (PSA 10- 20 ng/ml/ Grade group 2-3/ cT2a cT2b) or/and o -biopsy cores positive >=50% Patients belonging to a subclass of high risk group according to the D’Amico/NCCN risk group classification: o -ISUP group 4 (GS 4+4, 3+5, 5+3) or o -cT3a stage or o PSA>20 ng/ml Eastern Coooperative Oncology Group (ECOG) PS 0-2 Ability of the patient to understand and sign a written informed consent document Ability and Willingness to comply with patients reported outcome questionnaires schedule during the study time IPSS 0-15 Prostate Volume less than 100cc PSA must be dosed maximum 60 days before randomization No pathologic lymph nodes and distant metastasis on PET (fluorocholine) scan or CT scan+bone scan. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 110 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
Exclusion criteria: History 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. ¿ Previous prostate surgery other than TURP (at least 6 weeks prior to start of SBRT). ¿ Previous pelvic RT ¿ Prior androgen deprivation therapy (excluding 5alpha reductase inhibitors) ¿ Any prior active treatment for prostate cancer; patients on previous active surveillance areeligible if inclusion criteria are met ¿ Active severe inflammatory bowel disease ¿ Bilateral hip prothesis or any implant that could seriously interfere with dosimetric calculations ¿ Age >80 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to determinate if there is improvement in biochemical Disease Free Survival (bDFS) in patients treated with SBRT+ADT versus SBRT alone.;Secondary Objective: disease free survival (DFS), freedom from local recurrence (FFLR), freedom from regional recurrence (FFRR) freedom from distant metastasis (FFDM), overall survival (OS) acute and late toxicity, quality of life (QoL);Primary end point(s): To 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).;Timepoint(s) of evaluation of this end point: -At baseline, 1, 3, 6, and 12 months following treatment and yearly thereafter the following will be recorded: IIEF-5 and IPSS -At baseline, 1, 3, 6, and 12 months following treatment the following will be recorded: EPIC-26, EORTC PR25 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Disease free survival (DFS, defined as evidence of biochemical, local, regional or distant relapse on imaging). Freedom from local recurrence (FFLR, defined as evidence of in-field recurrence detected at imaging and/or Histologically proved);Timepoint(s) of evaluation of this end point: 3-5 years | — |
Countries
Italy
Contacts
Public Contactprogettazione ricerca
asst degli spedali civili di Brescia
Outcome results
None listed