Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07515651

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

This is a single arm trial that is recruiting a total of 50 participants that have been diagnosed with prostate bed (where the prostate was taken out) or regional (surrounding lymph nodes) recurrence of a prostate cancer following surgery. Salvage radiation treatment represents the main treatment option, with long-term cure rates on the order of 70%. Currently, salvage radiation treatment to the prostate bed and the pelvic lymph nodes is delivered using external beam radiation therapy (EBRT) in 20-33 sessions, over 4-6.5 weeks. Potential study participants have undergone a PSMA PET scan, which has found recurrent cancer in the prostate bed or lymph nodes. This study will investigate personalizing your radiation treatment based on this information. Participants on this study will receive lower than standard radiation dose to areas of the surgical site which do not show evidence of disease on the scan.

This personalized radiotherapy will be delivered in 5 treatments over two weeks, rather than the four to 6 weeks which is the current standard of care. Participants will have a routine history, blood collection for PSA and hormone levels, toxicity assessment, and EPIC-26 & IPSS questionnaires at each follow-up visit. These will take place at 1, 3, 6, 12, 24, 36, and 60 months after radiation treatment.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Prostate Cancer (Adenocarcinoma) Adenocarcinoma Carcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

University Health Network - Princess Margaret Cancer Center

Toronto, Ontario, M5G 2M9, Canada

Location contact

Andrew McPartlin, MD

CONTACT

[email protected]

416-946-4501 ext. 4855

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years old.
  • Histologically proven initial diagnosis of adenocarcinoma prostate cancer.
  • Radical prostatectomy > 6 months prior to commencing SBRT.
  • Biochemical relapse with local and/or regional recurrence proven with 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
  • Molecular imaging informed radiation dose escalation to sites of recurrent disease and de-escalation to uninvolved areas with SBRT, 25Gy in 5 fractions to prostate bed +/- pelvic lymph nodes delivered every other day with a boost to PSMA avid disease of 35 Gy in 5 fraction
  • Treatment of pelvic lymph nodes and androgen deprivation therapy for 0-24 months at clinician discretion

Primary outcomes

  1. Radiation-induced Acute Grade ≥2 Toxicity

    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) v6.0.

Secondary outcomes

  1. Acute and Late GI and GU toxicities

    Time frame: Estimated at 6 months and 2 years following treatment

    Cumulative incidence function will be used to estimate the cumulative incidence of grade ≥2 GI and GU, graded per Common Terminology Criteria for Adverse Events (CTCAE) v6.0.

  2. Local Recurrence

    Time frame: Estimated at 2 years and 5 years following treatment

    Cumulative incidence function with death as a competing risk will be used to estimate local recurrence

  3. Biochemical Disease Free Survival

    Time frame: Estimated at 2 years and 5 years following treatment

    Defined as survival until evidence of either biochemical progression (defined as a rise in prostate-specific antigen (PSA) ≥0.2ng/ml above the PSA nadir followed by a sequentially equal or higher value) following postoperative radiotherapy, clinical or radiological progression, initiation of non-protocol systemic therapy, or death from prostate cancer

  4. Patient-reported quality-of-life assessed by EPIC-26 and IPSS

    Time frame: Baseline to 5-year follow-up

    Patient-Reported Quality of Life will be assessed at baseline and at each follow-up visit (1, 3, 6, 12, 18, 24, 36, 48, and 60 months) using the following assessment questionnaires: EPIC-26 and IPSS

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-SBRT

Important dates

Study start
2026
Primary completion
2034
Study completion
2034
First posted
Apr 7, 2026
Registry last updated
Apr 7, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.