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

NCT05328505 | Recruiting

• 1 other identifier: 22-5147
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

This is a Phase II prospective single-arm trial that is recruiting 80 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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; adenocarcinoma; PSMA PET; radical prostatectomy; recurrence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Biochemical Failure Free Survival

  Baseline to 5-year follow-up

• Patient-reported quality-of-life assessed by EPIC-26

  Baseline to 5-year follow-up

Study Arms (1)

Molecular Imaging Informed Radiation Dose Escalation and De-escalation

EXPERIMENTAL

Molecular imaging informed radiation dose escalation to sites of recurrent disease and de-escalation to uninvolved areas.

Radiation: Image-guided Radiotherapy

Interventions

Image-guided Radiotherapy RADIATION

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.

Molecular Imaging Informed Radiation Dose Escalation and De-escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (2)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

RECRUITING

Princess Margaret Cancer Center

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma; Recurrence

Interventions

Radiotherapy, Image-Guided

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Central Study Contacts

Andrew McPartlin, MD

CONTACT

416-946-4501; andrew.mcpartlin@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 14, 2022
• Study Start: August 23, 2022
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2030
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

CA (2)