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Early Salvage Stereotactic Radiotherapy for Biochemical Failure After RP (esSBRT)

Primary Purpose

Prostatic Neoplasm

Status
Recruiting
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
salvage SBRT
Sponsored by
Regina Elena Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasm focused on measuring prostate cancer;, biochemical recurrence;, salvage radiotherapy;, SBRT;

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Regina Elena National Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

single arm, non randomized

radiation, SBRT

Arm Description

SBRT 30 Gy/ 5 fractions

SBRT 30 Gy/5 fractions to the prostatic bed +/- 25 Gy/5 fractions to the pelvic lymphnodes

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 30, 2022
Last Updated
December 19, 2022
Sponsor
Regina Elena Cancer Institute
Collaborators
Alessia Farneti, Adriana Faiella, Marta Bottero, Pasqualina D'Urso, Valeria Landoni, Antonella Soriani, Luca Bertini
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1. Study Identification

Unique Protocol Identification Number
NCT05667636
Brief Title
Early Salvage Stereotactic Radiotherapy for Biochemical Failure After RP
Acronym
esSBRT
Official Title
Early Salvage Stereotactic Radiotherapy (esSBRT) for Biochemical Failure After Radical Prostatectomy :a Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 2022 (Actual)
Primary Completion Date
September 27, 2023 (Anticipated)
Study Completion Date
September 27, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regina Elena Cancer Institute
Collaborators
Alessia Farneti, Adriana Faiella, Marta Bottero, Pasqualina D'Urso, Valeria Landoni, Antonella Soriani, Luca Bertini

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasm
Keywords
prostate cancer;, biochemical recurrence;, salvage radiotherapy;, SBRT;

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
103 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
single arm, non randomized
Arm Type
Experimental
Arm Description
SBRT 30 Gy/ 5 fractions
Arm Title
radiation, SBRT
Arm Type
Experimental
Arm Description
SBRT 30 Gy/5 fractions to the prostatic bed +/- 25 Gy/5 fractions to the pelvic lymphnodes
Intervention Type
Radiation
Intervention Name(s)
salvage SBRT
Intervention Description
steretactic body radiation therapy in the setting of salvage radiotherapy for prostate cancer
Primary Outcome Measure Information:
Title
3-yr BFFS
Description
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
Time Frame
3-years
Secondary Outcome Measure Information:
Title
3-y OS
Description
The secondary objective is 3-yr overal survival
Time Frame
3-years
Title
3-y LC
Description
The secondary objective is 3-yr locoregional control assessed with PSA
Time Frame
3-years
Title
3-y MFS
Description
The secondary objective is 3-yr metastases free survival
Time Frame
3-years
Title
3-y GU GI tox
Description
The secondary objective is 3-yr genitourinary and gastrointestinal toxicity according to CTCAE v5.0
Time Frame
3-years
Title
3-y QoL
Description
The secondary objective is 3-yr quality of life (FACT-P, IIF-5, ICIQ-SF, IPSS, IBQD)
Time Frame
3-years
Title
3-y - Patient satisfaction with treatment
Description
The secondary objective is 3-y patient satisfaction with treatment (FACIT-TS-G)
Time Frame
3-years

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giuseppe Sanguineti, Professor
Phone
0652663015
Email
giuseppe.sanguineti@ifo.it
First Name & Middle Initial & Last Name or Official Title & Degree
Paola Franzoso, DM
Phone
0652666125
Email
paola.franzoso@ifo.it
Facility Information:
Facility Name
Regina Elena National Cancer Institute
City
Rome
ZIP/Postal Code
00144
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
giuseppe sanguineti, Professor
Phone
0652661530
Email
giuseppe.sanguineti@ifo.it
First Name & Middle Initial & Last Name & Degree
Paola Franzoso, DM
Phone
0652666125
Email
paola.franzoso@ifo.it

12. IPD Sharing Statement

Plan to Share IPD
No

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Early Salvage Stereotactic Radiotherapy for Biochemical Failure After RP

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