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

Prostate Cancer Clinical Trial

— MIDAS-Prostate  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05328505
• Other study ID #: 22-5147
• Status: Recruiting
• Phase: N/A
• Start date: August 5, 2022
• Est. completion date: August 2030

Study information

• Verified date: June 2024
• Source: University Health Network, Toronto
• Contact: Srinivas Raman, MD
• Phone: 416-946-2320
• Email: srinivas.raman[@]rmp.uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2030
• Est. primary completion date: August 2028
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Image-guided Radiotherapy
de-escalation radiotherapy to elective volumes + simultaneous integrated boost to PSMA avid lesions delivered in 20 fractions +/- ADT (clinical decision). The elective prostate bed and pelvic lymph node regions will receive 45 Gy. The PSMA-avid lymph node(s) will receive an SIB to 55-60 Gy and/or the PSMA-avid lesion in the prostate bed will receive an SIB to 60 Gy. Pelvic nodal treatment and ADT use will be left to the discretion of the treating physician.

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Center	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grade =2 Toxicity for GU	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.	Baseline to 5-year follow-up
Secondary	Biochemical Failure Free Survival	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	Baseline to 5-year follow-up
Secondary	Patient-reported quality-of-life assessed by EPIC-26	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)	Baseline to 5-year follow-up