Stereotactic body radiation therapy on Prostate with or without Androgen deprivation therapy, a phase III randomized controlled trial (SPA Trial)

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia23 sites in 1 country310 target enrollmentJanuary 31, 2025

DrugsDECAPEPTYL 22,5 mg / 2ml - Polvere e solvente per sospensione iniettabile a rilascio prolungato Casodex 50 mg comprimate filmate TRIPTORELINE

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Not specified
Sponsor: Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Enrollment: 310
Locations: 23
Primary Endpoint: • 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).
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To determinate if there is improvement in biochemical Disease Free Survival (bDFS) in patients treated with SBRT+ADT versus SBRT alone.

Registry

euclinicaltrials.eu

Start Date

January 31, 2025

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Investigators

Sponsor

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Responsible Party

Principal Investigator

SC Clinical Trial Center - Dr. Aldo Maria Roccaro

Scientific

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Eligibility Criteria

Inclusion Criteria

•Age 18-80 years old.
•Prostate Volume less than 100cc
•PSA must be dosed maximum 60 days before randomization
•No pathologic lymph nodes and distant metastasis on PET scan (fluorocholine or fluoroPSMA- galliumPSMA ) or CT scan+bone scan.
•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/ cT2b-cT2c) 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, excluding 3+5 and 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

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. 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).
•Controindication or hypersensitivity to the use of Triptoreline
•5alpha reductase inhibitors not discontinued 4 weeks prior to randomization
•History of bone fractures and fall
•Risk factors for abnormal heart rhythms or QT prolongation.
•Use of concomitant medications that prolong the QT/QTc interval
•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 are eligible if inclusion criteria are met

Outcomes

Primary Outcomes

• 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).

Secondary Outcomes

• Freedom from distant metastasis (FFDM, defined as evidence of out of field recurrence that meets the criteria of M1 defined by TNM VIII)
• 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)
• Freedom 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)
• Overall Survival (OS, defined as death for any cause)