Sbrt±sTad for Unfavorable iNtermediate rIsk/High Risk Prostate caNcer
NCT ID: NCT05557604
Last Updated: 2022-09-28
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
PHASE2
146 participants
INTERVENTIONAL
2021-02-02
2027-02-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Randomization is centralized at the promoter and takes place according to a specific procedure (in attachment).
The randomization schedule will be generated by an independent group of the promoter.
Patient study number and result of randomization will be given immediately by email.
Study Groups
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arm 1
SBRT alone 38 GY in 4 fractions
No interventions assigned to this group
arm 2
SBRT along with short course (6 months) androgen deprivation (STAD)
Decapeptyl
STAD androgen deprivation
Interventions
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Decapeptyl
STAD androgen deprivation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* IR or HR in the NCCN definition
* N0M0 at staging with choline or (preferably) PSMA PET-CT;
* ECOG performance status between 0 and 2;
Exclusion Criteria
* Previous radiotherapy to the pelvis
* Previous chemotherapy for malignancy in past 5 years
* Impossibility to implant fiducials for tracking purposes
* Impossibility to undergo MRI of the prostate
* Contraindication to short term AD
* Prostate volume \>90cc
18 Years
90 Years
MALE
No
Sponsors
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Regina Elena Cancer Institute
OTHER
Responsible Party
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Giuseppe Sanguineti
Professore
Locations
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Ifo Regina elena
Rome, Lazio, Italy
ifo Regina Elena
Rome, RM, Italy
Regina Elena National Cancer Institute
Rome, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RS1399/20(2384) PU
Identifier Type: -
Identifier Source: org_study_id
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