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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-05

Study Completion Date

2030-08-31

Brief Summary

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This is a Phase II prospective sing-arm trial that is recruiting 60 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.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Image-guided Radiotherapy

Intervention Type 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.

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.

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Princess Margaret Cancer Center

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Andrew McPartlin, MD

Role: CONTACT

416-946-4501 ext. 4855

Facility Contacts

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Andrew McPartlin, MD

Role: primary

Other Identifiers

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22-5147

Identifier Type: -

Identifier Source: org_study_id

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