Early Salvage Stereotactic Radiotherapy for Biochemical Failure After RP

Prostatic Neoplasm Clinical Trial

— esSBRT  

Official title:

Early Salvage Stereotactic Radiotherapy (esSBRT) for Biochemical Failure After Radical Prostatectomy :a Phase II Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05667636
• Other study ID #: RS1705/22 (2678)
• Status: Recruiting
• Phase: Phase 2
• Start date: September 27, 2022
• Est. completion date: September 27, 2024

Study information

• Verified date: December 2022
• Source: Regina Elena Cancer Institute
• Contact: Giuseppe Sanguineti, Professor
• Phone: 0652663015
• Email: giuseppe.sanguineti[@]ifo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 103
• Est. completion date: September 27, 2024
• Est. primary completion date: September 27, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Neoplasm
• Prostatic Neoplasms

Intervention

Radiation:
• salvage SBRT
steretactic body radiation therapy in the setting of salvage radiotherapy for prostate cancer

Locations

Country	Name	City	State
Italy	Regina Elena National Cancer Institute	Rome

Sponsors (8)

Lead Sponsor	Collaborator
Regina Elena Cancer Institute	Adriana Faiella, Alessia Farneti, Antonella Soriani, Luca Bertini, Marta Bottero, Pasqualina D'Urso, Valeria Landoni

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-yr BFFS	The primary objective of the study is 3-yr biochemical failure free survival of the stereotactic approach in 5 fractions in the context of salvage radiotherapy for biochemical failure after RP	3-years
Secondary	3-y OS	The secondary objective is 3-yr overal survival	3-years
Secondary	3-y LC	The secondary objective is 3-yr locoregional control assessed with PSA	3-years
Secondary	3-y MFS	The secondary objective is 3-yr metastases free survival	3-years
Secondary	3-y GU GI tox	The secondary objective is 3-yr genitourinary and gastrointestinal toxicity according to CTCAE v5.0	3-years
Secondary	3-y QoL	The secondary objective is 3-yr quality of life (FACT-P, IIF-5, ICIQ-SF, IPSS, IBQD)	3-years
Secondary	3-y - Patient satisfaction with treatment	The secondary objective is 3-y patient satisfaction with treatment (FACIT-TS-G)	3-years