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

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ClinicalTrials.gov Identifier: NCT05328505
Recruitment Status : Recruiting
First Posted : April 14, 2022
Last Update Posted : October 7, 2022
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Image-guided Radiotherapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas in Salvage Radiotherapy for Prostate Cancer
Estimated Study Start Date : November 2022
Estimated Primary Completion Date : August 2028
Estimated Study Completion Date : August 2030

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Radiation: 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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05328505


Contacts
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Contact: Srinivas Raman, MD 416-946-2320 srinivas.raman@rmp.uhn.ca

Locations
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Canada, Ontario
Princess Margaret Cancer Center Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Srinivas Raman, MD    416-946-2320    srinivas.raman@rmp.uhn.ca   
Sponsors and Collaborators
University Health Network, Toronto
More Information
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT05328505    
Other Study ID Numbers: 22-5147
First Posted: April 14, 2022    Key Record Dates
Last Update Posted: October 7, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Health Network, Toronto:
Prostate Cancer
adenocarcinoma
PSMA PET
radical prostatectomy
recurrence
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases