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

Phase 1

• Conditions: prostate acinar adenocarcinoma; MedDRA version: 20.0Level: LLTClassification code 10007453Term: Carcinoma of the prostate metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: LLTClassification code 10001201Term: Adenocarcinoma of the prostate stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: LLTClassification code 10007456Term: Carcinoma of the prostate stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: LLTClassification code 10036951Term: Prostatic cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: PTClassification code 10036918Term: Prostate cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: LLTClassification code 10001202Term: Adenocarcinoma of the prostate stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: LLTClassification code 10007457Term: Carcinoma of the prostate stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: LLTClassification code 10036952Term: Prostatic cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: PTClassification code 10036919Term: Prostate cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2020-005754-23-IT
• Lead Sponsor: AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-07
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 310

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to determinate if there is improvement in biochemical Disease Free Survival (bDFS) in patients treated with SBRT+ADT versus SBRT<br>alone.;Secondary Objective: disease free survival (DFS), freedom from local recurrence (FFLR), freedom from regional recurrence (FFRR) freedom from distant<br>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<br>PSA elevation = 2 ng/ml over Nadir, following the Phoenix criteria) in patients treated with<br>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<br>-At baseline, 1, 3, 6, and 12 months following treatment the following will be recorded: EPIC-26, EORTC PR25

Secondary Outcome Measures

Name	Time	Method
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