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
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|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Radiation: Image-guided Radiotherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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
- 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)
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- 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
- Presence of para-aortic lymph nodes or distant metastasis.
- Chronic pelvic inflammatory disease.
- Contraindication for radiation treatment.
- Previous radiation treatment within the pelvis
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
|Contact: Srinivas Raman, MDfirstname.lastname@example.org|
|Princess Margaret Cancer Center||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Srinivas Raman, MD 416-946-2320 email@example.com|
|Responsible Party:||University Health Network, Toronto|
|Other Study ID Numbers:||
|First Posted:||April 14, 2022 Key Record Dates|
|Last Update Posted:||October 7, 2022|
|Last Verified:||October 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Genital Neoplasms, Male
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