Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas in Salvage Radiotherapy for Prostate Cancer

Not Applicable

Recruiting

• Conditions: Prostate Cancer
• Interventions: Radiation: Image-guided Radiotherapy

• Registration Number: NCT05328505
• Lead Sponsor: University Health Network, Toronto

Brief Summary

This is a Phase II prospective sing-arm trial that is recruiting 60 participants from patients that have biochemical failure after radical prostatectomy with local or regional recurrence proven by PSMA PET. Participants of this study will receive molecular imaging informed radiation dose escalation to site of recurrent disease and de-escalation to uninvolved areas. Participants will be follow-up as per standard of care up to 5 years post-treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-07
• Study First Submitted QC: 2022-04-07
• Study First Posted: 2022-04-14
• Study Start: 2022-08-05
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-18
• Primary Completion: 2028-08
• Study Completion: 2030-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• Men older than 18 years old.
• Histologically proven initial diagnosis of adenocarcinoma prostate cancer.
• Previous radical prostatectomy.
• Biochemical relapse with local or regional recurrence proven on PSMA PET.
• Five or less positive nodes on the PSMA PET.
• ECOG 0-1

Read More

Exclusion Criteria

• Presence of para-aortic lymph nodes or distant metastasis.
• Chronic pelvic inflammatory disease.
• Contraindication for radiation treatment.
• Previous radiation treatment within the pelvis

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Molecular Imaging Informed Radiation Dose Escalation and De-escalation	Image-guided Radiotherapy	Molecular imaging informed radiation dose escalation to sites of recurrent disease and de-escalation to uninvolved areas.

Primary Outcome Measures

Name	Time	Method
Grade ≥2 Toxicity for GU	Baseline to 5-year follow-up	Acute (less than or equal to 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Secondary Outcome Measures

Name	Time	Method
Biochemical Failure Free Survival	Baseline to 5-year follow-up	Biochemical control rate will be assessed at baseline and at each follow-up visit (1, 3, 6, 12, 18, 24, 36, 48, and 60 months) by the blood level of prostate-specific antigen (PSA) levels
Patient-reported quality-of-life assessed by EPIC-26	Baseline to 5-year follow-up	Patient-Reported Quality of Life will be assessed at baseline and at each follow-up visit (3-weeks post intervention then every 6 months until 5 years, or more frequently if clinically necessary) using the following assessment questionnaires: 26-Item Expanded Prostate Cancer Index Composite (EPIC-26)

Trial Locations

Locations (1)

Princess Margaret Cancer Center; 🇨🇦 Toronto, Ontario, Canada