Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas in Salvage Radiotherapy for Prostate Cancer
NCT ID: NCT05328505
Last Updated: 2024-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2022-08-05
2030-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Chronic pelvic inflammatory disease.
* Contraindication for radiation treatment.
* Previous radiation treatment within the pelvis
18 Years
MALE
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Locations
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Princess Margaret Cancer Center
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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22-5147
Identifier Type: -
Identifier Source: org_study_id
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