Early Salvage Stereotactic Radiotherapy for Biochemical Failure After RP
NCT ID: NCT05667636
Last Updated: 2022-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
103 participants
INTERVENTIONAL
2022-09-27
2024-09-27
Brief Summary
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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
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Selected patients will receive 6-month LHRH analogue preceded by Bicalutamide tablet 50 mg, daily, for 2 weeks to control for possible tumor flare.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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single arm, non randomized
SBRT 30 Gy/ 5 fractions
salvage SBRT
steretactic body radiation therapy in the setting of salvage radiotherapy for prostate cancer
radiation, SBRT
SBRT 30 Gy/5 fractions to the prostatic bed +/- 25 Gy/5 fractions to the pelvic lymphnodes
salvage SBRT
steretactic body radiation therapy in the setting of salvage radiotherapy for prostate cancer
Interventions
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salvage SBRT
steretactic body radiation therapy in the setting of salvage radiotherapy for prostate cancer
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
MALE
No
Sponsors
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Alessia Farneti
UNKNOWN
Adriana Faiella
UNKNOWN
Marta Bottero
UNKNOWN
Pasqualina D'Urso
UNKNOWN
Valeria Landoni
UNKNOWN
Antonella Soriani
UNKNOWN
Luca Bertini
UNKNOWN
Regina Elena Cancer Institute
OTHER
Responsible Party
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Giuseppe Sanguineti
Professor
Locations
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Regina Elena National Cancer Institute
Rome, , Italy
Countries
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Central Contacts
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Facility Contacts
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giuseppe sanguineti, Professor
Role: primary
Paola Franzoso, DM
Role: backup
Other Identifiers
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RS1705/22 (2678)
Identifier Type: -
Identifier Source: org_study_id