Recruiting

Molecular Imaging

Sponsor:

University Health Network, Toronto

Code:

NCT05328505

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Image-guided Radiotherapy

Study Details

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

Study ID

NCT05328505

Start date

Aug 23, 2022

Status verified date

Mar, 2026

Completion date

Aug, 2030

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Molecular Imaging Informed Radiation Dose Escalation and De-escalation

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

Interventions

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.

Primary outcome measure

  • Grade ≥2 Toxicity for GU [ Time Frame: Baseline to 5-year follow-up ]

Central Contacts and Locations

Central contacts

Andrew McPartlin, MD

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

Locations

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Michael Lock, MD

519-685-8650michael.lock@lhsc.on.ca

Princess Margaret Cancer Center

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Andrew McPartlin, MD

andrew.mcpartlin@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Mar 24, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-03-24.