Clinical trial NCT05667636: Early Salvage Stereotactic Radiotherapy for Biochemical Failure After RP
Official title: Early Salvage Stereotactic Radiotherapy (esSBRT) for Biochemical Failure After Radical Prostatectomy :a Phase II Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Prostatic Neoplasm
Keywords: prostate cancer;
biochemical recurrence;
salvage radiotherapy;
SBRT;
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
Collaborators: name: Alessia Farneti
name: Adriana Faiella
name: Marta Bottero
name: Pasqualina D'Urso
name: Valeria Landoni
name: Antonella Soriani
name: Luca Bertini
First posted: 2022-12-28
Enrollment: 103
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: After radical prostatectomy, 30-60% of patients will develop recurrent disease. Salvage radiotherapy, usually at 2 Gy per fraction, is the main treatment option for these patients.

The aim of the present study is to determine the 3-yr biochemical failure free survival of the stereotactic approach in 5 fractions in the context of salvage radiotherapy for biochemical failure after radical prostatectomy.

Detailed description: The present study aims at delivering 30 Gy to the prostatic bed in 5 fractions. At the same time, the pelvic nodes will be covered to 25 Gy, but in those patients considered at low risk of nodal involvement. In patients with evidence of macroscopic disease at the tumor bed through DCE-MRI, 40 Gy will be delivered in 5 fractions.

Selected patients will receive 6-month LHRH analogue preceded by Bicalutamide tablet 50 mg, daily, for 2 weeks to control for possible tumor flare.

Eligibility criteria: Inclusion Criteria:

* - Able and willing to provide informed consent;
* Pathologically proven diagnosis of prostatic adenocarcinoma;
* Biochemical failure (2 consecutive PSA rises above 0.2 ng/ml) after radical prostatectomy;
* No regional or distant metastases;
* Eastern Cooperative Oncology Group performance status 0-1

Exclusion Criteria:

* - Previous local treatment of the prostate with radiotherapy, brachytherapy, cryosurgery, high-intensity focused ultrasound or cryotherapy;
* Previous radiotherapy to the pelvis;
* Previous or current symptomatic vesicourethral anastomotic stenosis post-RP (weak stream, straining to void, hesitancy and incomplete bladder emptying);
* PSA level at sRT\> 2 ng/ml;
* (Each single) Lesion volume within the prostatic fossa at mpMR \>5 cc;
* Previous chemotherapy for malignancy in past 5 years;
* Previous androgen deprivation for biochemical failure after RP;
* Contraindication to short term AD (in case of Px)
* Presence of nodal or distant metastasis, as confirmed by magnetic resonance (MR) or PET/CT
* Pathologically positive lymph nodes (pN+) at RP;
* Serious medical comorbidities or other contraindications to radiotherapy
* Presence of active inflammatory bowel disease;
* Presence of active connective tissue disease;
* Unable or unwilling to complete quality of life questionnaires

Primary outcomes:
measure: 3-yr BFFS
timeFrame: 3-years
Secondary outcomes:
measure: 3-y OS
timeFrame: 3-years
measure: 3-y LC
timeFrame: 3-years
measure: 3-y MFS
timeFrame: 3-years
measure: 3-y GU GI tox
timeFrame: 3-years
measure: 3-y QoL
timeFrame: 3-years
measure: 3-y - Patient satisfaction with treatment
timeFrame: 3-years
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Regina Elena National Cancer Institute
Study officials:
References: