STereotactic sAlvage Radiotherapy for Macroscopic Prostate Bed Recurrence After prostatectomy-a Prospective Observational Study (STARR)

STereotactic sAlvage Radiotherapy for Macroscopic Prostate Bed Recurrence After prostatectomy-a Prospective Observational Study -STARR

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer; Relapse
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

Study Locations

• Italy
  • Florence, Italy, 50134
    • Recruiting
    • AOU Careggi Radiation Oncology Unit
    • Contact: Giulio Francolini; Email: Francolinigiulio@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Patients affected by macroscopic prostate bed relapse

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemical relapse free survival (BRFS)	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.	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of patients with complete response	Complete response is defined as PSA nadir <0.2 ng/ml	at 2 years after treatment

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero-Universitaria Careggi

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 11, 2021
• Primary Completion (ANTICIPATED): July 11, 2023
• Study Completion (ANTICIPATED): July 11, 2024

Study Registration Dates

• First Submitted: July 8, 2022
• First Submitted That Met QC Criteria: July 8, 2022
• First Posted (ACTUAL): July 13, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 13, 2022
• Last Update Submitted That Met QC Criteria: July 8, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: STARR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No