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

University Health Network, Toronto

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Radiation: Image-guided Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05328505

22-5147

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

80 participants in 1 patient group

Molecular Imaging Informed Radiation Dose Escalation and De-escalation

Experimental group

Description:

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

Treatment:

Radiation: Image-guided Radiotherapy