NCT05667636

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
103

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 27, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 28, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2024

Completed
Last Updated

December 28, 2022

Status Verified

December 1, 2022

Enrollment Period

1 year

First QC Date

September 30, 2022

Last Update Submit

December 19, 2022

Conditions

Prostatic Neoplasm

Keywords

prostate cancer;biochemical recurrence;salvage radiotherapy;SBRT;

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 3-y OS

    3-years

  • 3-y LC

    3-years

  • 3-y MFS

    3-years

  • 3-y GU GI tox

    3-years

  • 3-y QoL

    3-years

  • +1 more secondary outcomes

Study Arms (2)

single arm, non randomized

EXPERIMENTAL

SBRT 30 Gy/ 5 fractions

Radiation: salvage SBRT

radiation, SBRT

EXPERIMENTAL

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

Radiation: salvage SBRT

Interventions

salvage SBRTRADIATION

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

radiation, SBRTsingle arm, non randomized

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regina Elena National Cancer Institute

Rome, 00144, Italy

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Central Study Contacts

Giuseppe Sanguineti, Professor

CONTACT

0652663015giuseppe.sanguineti@ifo.it

Paola Franzoso, DM

CONTACT

0652666125paola.franzoso@ifo.it

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 30, 2022

First Posted

December 28, 2022

Study Start

September 27, 2022

Primary Completion

September 27, 2023

Study Completion

September 27, 2024

Last Updated

December 28, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)