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esSBRT: Early Salvage Stereotactic Radiotherapy for Biochemical Failure After RP

Sponsor
Regina Elena Cancer Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05667636
Collaborator
Alessia Farneti (Other), Adriana Faiella (Other), Marta Bottero (Other), Pasqualina D'Urso (Other), Valeria Landoni (Other), Antonella Soriani (Other), Luca Bertini (Other)
103
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
4.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: salvage SBRT
 Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
103 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Early Salvage Stereotactic Radiotherapy (esSBRT) for Biochemical Failure After Radical Prostatectomy :a Phase II Study
Actual Study Start Date :
Sep 27, 2022
Anticipated Primary Completion Date :
Sep 27, 2023
Anticipated Study Completion Date :
Sep 27, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: single arm, non randomized

SBRT 30 Gy/ 5 fractions

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

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

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 3-y OS [3-years]

    The secondary objective is 3-yr overal survival

  2. 3-y LC [3-years]

    The secondary objective is 3-yr locoregional control assessed with PSA

  3. 3-y MFS [3-years]

    The secondary objective is 3-yr metastases free survival

  4. 3-y GU GI tox [3-years]

    The secondary objective is 3-yr genitourinary and gastrointestinal toxicity according to CTCAE v5.0

  5. 3-y QoL [3-years]

    The secondary objective is 3-yr quality of life (FACT-P, IIF-5, ICIQ-SF, IPSS, IBQD)

  6. 3-y - Patient satisfaction with treatment [3-years]

    The secondary objective is 3-y patient satisfaction with treatment (FACIT-TS-G)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Regina Elena National Cancer Institute Rome Italy 00144

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Giuseppe Sanguineti, Professor, Regina Elena Cancer Institute
ClinicalTrials.gov Identifier:
NCT05667636
Other Study ID Numbers:
  • RS1705/22 (2678)
First Posted:
Dec 28, 2022
Last Update Posted:
Dec 28, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Giuseppe Sanguineti, Professor, Regina Elena Cancer Institute
prostate cancer;
biochemical recurrence;
salvage radiotherapy;
SBRT;
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Dec 28, 2022