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

Sponsor

University Health Network, Toronto (Other)

Overall Status

Recruiting

CT.gov ID

NCT05328505

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2028

Anticipated Study Completion Date :

Aug 1, 2030

Arms and Interventions

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.

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

Primary Outcome Measures

Grade ≥2 Toxicity for GU [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

Biochemical Failure Free Survival [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 [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Princess Margaret Cancer Center	Toronto	Ontario	Canada	M5G 2M9

Sponsors and Collaborators

University Health Network, Toronto

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT05328505

Other Study ID Numbers:

22-5147

First Posted:

Apr 14, 2022

Last Update Posted:

Aug 11, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Health Network, Toronto

Prostate Cancer

adenocarcinoma

PSMA PET

radical prostatectomy

recurrence

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Aug 11, 2022