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Trial record 1 of 1 for:    NCT05455736
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STereotactic sAlvage Radiotherapy for Macroscopic Prostate Bed Recurrence After prostatectomy-a Prospective Observational Study (STARR)

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ClinicalTrials.gov Identifier: NCT05455736
Recruitment Status : Recruiting
First Posted : July 13, 2022
Last Update Posted : July 13, 2022
Sponsor:
Information provided by (Responsible Party):
Lorenzo Livi, Azienda Ospedaliero-Universitaria Careggi

Study Description
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Brief Summary:
STereotactic sAlvage Radiotherapy for macroscopic prostate bed Recurrence after prostatectomy (STARR trial) is a prospective observational study aimed to assess outcome after Stereotactic salvage radiotherapy (SSRT) for macroscopic prostate bed recurrence after radical prostatectomy.

Condition or disease Intervention/treatment
Prostate Cancer Relapse Other: Stereotactic salvage radiotherapy for macroscopic prostate bed relapse

Detailed Description:

This is a prospective observational multicenter study including patients affected by patients with macroscopic recurrence within prostate bed after RP detected with Choline or PSMA CT-PET and confirmed with pelvic MRI (except for cases in which MRI is contraindicated). Patients will be treated with SSRT on macroscopic prostate bed recurrence for a total dose of from 35 in 5 fractions. Planned size of the overall study population is 90 patients. The study will include a screening phase and a treatment phase. The screening phase allows for assessment of subject eligibility, demographics, PSA, comorbidities and current drug therapies up to 45 days prior to randomization.

The treatment phase consists of SSRT administered on prostate bed macroscopic recurrence. Different techniques will be allowed provided that treatment respects doses and fractionation indicated per-protocol (35 Gy in 5 fractions) and that dose constraints to organs at risk (OAR) reported in this document are observed. The total planned duration of the study is 40 months, consisting in 16 months enrollment period, during which patients will perform the screening and and later phase of 24 months in which patients will continue to be submitted to periodic checks every 3 months.

Study Design
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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: STereotactic sAlvage Radiotherapy for Macroscopic Prostate Bed Recurrence After prostatectomy-a Prospective Observational Study -STARR
Actual Study Start Date : March 11, 2021
Estimated Primary Completion Date : July 11, 2023
Estimated Study Completion Date : July 11, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: Stereotactic salvage radiotherapy for macroscopic prostate bed relapse
    Stereotactic prostate salvage radiotherapy administered on prostate bed macroscopic recurrence. Different techniques will be allowed provided that treatment respects doses and fractionation indicated per-protocol (35 Gy in 5 fractions)

Outcome Measures
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Primary Outcome Measures :
  1. Biochemical relapse free survival (BRFS) [ Time Frame: 2 year ]
    Primary endpoint of the study is BRFS after treatment, biochemical relapse is defined as a PSA increase above 0.2 ng/ml for patients with a PSA nadir < 0.2 ng/ml or 2 consecutive PSA increases > 25% if compared to nadir in patients with a PSA nadir > 0.2 ng/ml.


Secondary Outcome Measures :
  1. Rate of patients with complete response [ Time Frame: at 2 years after treatment ]
    Complete response is defined as PSA nadir <0.2 ng/ml


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients affected by macroscopic prostate bed relapse
Criteria

Inclusion Criteria:

  • Patients affected by biochemical recurrence after radical prostatectomy for prostate cancer (defined as a PSA increase > 0.2 ng/ml)
  • Presence of macroscopic recurrence in prostate bed, determined with either Choline or PSMA PET imaging and confirmed through MRI (except for cases in which MRI is contraindicated)
  • Absence of distant and/or regional sites of disease outside prostate bed
  • Patients free from Androgen deprivation therapy (ADT) (Adjuvant ADT after radical prostatectomy for pN+ patients is allowed if > 12 months from biochemical recurrence)

Exclusion Criteria:

  • Presence of distant and/or regional sites of disease outside prostate bed
  • Patient undergoing ADT or withdrawal of adjuvant ADT within12 months from biochemical recurrence
  • Absence of disease detection from one of the two imaging modalities used (Choline or PSMA Pet and MRI must be positive- except for cases in which MRI is contraindicated)
  • Any condition for which, in the opinion of the treating physician, SSRT would be contraindicated for the patient (i.e peristence of moderate/severe urinary distress after prostatectomy, post-surgical complications etc)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05455736


Locations
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Italy
AOU Careggi Radiation Oncology Unit Recruiting
Florence, Italy, 50134
Contact: Lorenzo Livi, Prof.    +390557947264    segr-radiotp@dfc.unifi.it   
Contact: Giulio Francolini       Francolinigiulio@gmail.com   
Sponsors and Collaborators
Azienda Ospedaliero-Universitaria Careggi
More Information
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Responsible Party: Lorenzo Livi, Full Professor, Azienda Ospedaliero-Universitaria Careggi
ClinicalTrials.gov Identifier: NCT05455736    
Other Study ID Numbers: STARR
First Posted: July 13, 2022    Key Record Dates
Last Update Posted: July 13, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Recurrence
Disease Attributes
Pathologic Processes