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NCT Number: NCT05328505

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

London Health Sciences Centre, London, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Grade ≥2 Toxicity for GU

    Time frame: 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 outcomes

  1. Biochemical Failure Free Survival

    Time frame: 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

  2. Patient-reported quality-of-life assessed by EPIC-26

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew McPartlin, MD

CONTACT

[email protected]

416-946-4501 ext. 4855

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Acronym: MIDAS-Prostate

Important dates

Study start
2022
Primary completion
2028
Study completion
2030
First posted
Apr 14, 2022
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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