Early Salvage Stereotactic Radiotherapy for Biochemical Failure After RP

Phase 2

Recruiting

• Conditions: Prostatic Neoplasm
• Interventions: Radiation: salvage SBRT

• Registration Number: NCT05667636
• Lead Sponsor: Regina Elena Cancer Institute

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.

Study Timeline

• Study Start: 2022-09-27
• Study First Submitted: 2022-09-30
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-19
• Last Update Submitted: 2022-12-19
• Study First Posted: 2022-12-28
• Last Update Posted: 2022-12-28
• Primary Completion: 2023-09-27
• Study Completion: 2024-09-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 103

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
radiation, SBRT	salvage SBRT	SBRT 30 Gy/5 fractions to the prostatic bed +/- 25 Gy/5 fractions to the pelvic lymphnodes
single arm, non randomized	salvage SBRT	SBRT 30 Gy/ 5 fractions

Primary Outcome Measures

Name	Time	Method
3-yr BFFS	3-years	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

Secondary Outcome Measures

Name	Time	Method
3-y LC	3-years	The secondary objective is 3-yr locoregional control assessed with PSA
3-y GU GI tox	3-years	The secondary objective is 3-yr genitourinary and gastrointestinal toxicity according to CTCAE v5.0
3-y - Patient satisfaction with treatment	3-years	The secondary objective is 3-y patient satisfaction with treatment (FACIT-TS-G)
3-y QoL	3-years	The secondary objective is 3-yr quality of life (FACT-P, IIF-5, ICIQ-SF, IPSS, IBQD)
3-y MFS	3-years	The secondary objective is 3-yr metastases free survival
3-y OS	3-years	The secondary objective is 3-yr overal survival

Trial Locations

Locations (1)

Regina Elena National Cancer Institute; 🇮🇹 Rome, Italy