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Not yet recruiting 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

Phase II Interventional Prostate Cancer (Adenocarcinoma)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Image-guided Radiotherapy.
Who it may be relevant to
Registry conditions: Prostate Cancer (Adenocarcinoma). Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Radiation Image-guided Radiotherapy
    * 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 outcome measures

  • Radiation-induced Acute Grade ≥2 Toxicity [Time frame: Baseline to 5-year follow up]
Secondary outcome measures (4)
  • Acute and Late GI and GU toxicities [Time frame: Estimated at 6 months and 2 years following treatment]
  • Local Recurrence [Time frame: Estimated at 2 years and 5 years following treatment]
  • Biochemical Disease Free Survival [Time frame: Estimated at 2 years and 5 years following treatment]
  • Patient-reported quality-of-life assessed by EPIC-26 and IPSS [Time frame: Baseline to 5-year follow-up]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • University Health Network - Princess Margaret Cancer Center — Toronto

Identifiers

NCT: NCT07515651 · 25-6057

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗