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Sbrt±sTad for Unfavorable iNtermediate rIsk/High Risk Prostate caNcer (STUNNIN)

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Decapeptyl
Sponsored by
Regina Elena Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring neoplasm, prostate cancer,

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically proven prostate adenocarcinoma
  • 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 local treatment of the prostate with surgery (radical prostatectomy or cryotherapy)
  • 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

Sites / Locations

  • Ifo Regina elenaRecruiting
  • ifo Regina ElenaRecruiting
  • Regina Elena National Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

arm 1

arm 2

Arm Description

SBRT alone 38 GY in 4 fractions

SBRT along with short course (6 months) androgen deprivation (STAD)

Outcomes

Primary Outcome Measures

3-yr bNED survival
The primary objective of the study is 3-yr bNED survival. If bNED survival is not significantly different between the two experimental arms, the one without AD will be chosen in a future comparison with the standard of care.

Secondary Outcome Measures

Full Information

First Posted
September 23, 2022
Last Updated
September 23, 2022
Sponsor
Regina Elena Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05557604
Brief Title
Sbrt±sTad for Unfavorable iNtermediate rIsk/High Risk Prostate caNcer
Acronym
STUNNIN
Official Title
Sbrt±sTad for Unfavorable iNtermediate rIsk/High Risk Prostate caNcer (STUNNIN): A Randomized Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2021 (Actual)
Primary Completion Date
February 2, 2024 (Anticipated)
Study Completion Date
February 2, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regina Elena Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a prospective, open, randomized phase II trial.
Detailed Description
Patients will be randomized between SBRT alone (38 Gy in 4 fractions) or SBRT (same schedule) along with short course (6 months) androgen deprivation (STAD). All patients will be treated by intensity modulated radiotherapy. Regarding the combined modality approach, SBRT has to start within 3 months from the first injection of LHRH analogue.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
neoplasm, prostate cancer,

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
prospective, open, randomized phase 2 trial
Masking
Investigator
Masking Description
Subjects who meet all study eligibility criteria will be randomly assigned in a 1:1 ratio. 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.
Allocation
Randomized
Enrollment
146 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
arm 1
Arm Type
No Intervention
Arm Description
SBRT alone 38 GY in 4 fractions
Arm Title
arm 2
Arm Type
Experimental
Arm Description
SBRT along with short course (6 months) androgen deprivation (STAD)
Intervention Type
Drug
Intervention Name(s)
Decapeptyl
Other Intervention Name(s)
Enantone
Intervention Description
STAD androgen deprivation
Primary Outcome Measure Information:
Title
3-yr bNED survival
Description
The primary objective of the study is 3-yr bNED survival. If bNED survival is not significantly different between the two experimental arms, the one without AD will be chosen in a future comparison with the standard of care.
Time Frame
3 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically proven prostate adenocarcinoma 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 local treatment of the prostate with surgery (radical prostatectomy or cryotherapy) 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giuseppe Sanguineti, Professor
Phone
0652663015
Email
giuseppe.sanguineti@ifo.it
Facility Information:
Facility Name
Ifo Regina elena
City
Rome
State/Province
Lazio
ZIP/Postal Code
00144
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Sanguineti, Professor
Phone
0652661530
Email
giuseppe.sanguineti@ifo.it
First Name & Middle Initial & Last Name & Degree
Paola Franzoso, DM
Phone
0652666125
Email
paola.franzoso@ifo.it
Facility Name
ifo Regina Elena
City
Rome
State/Province
RM
ZIP/Postal Code
00144
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
giuseppe sanguineti, Professor
Phone
0652661530
Email
giuseppe.sanguineti@ifo.it
First Name & Middle Initial & Last Name & Degree
Paola Franzoso, data manager
Phone
0652666125
Email
paola.franzoso@ifo.it
Facility Name
Regina Elena National Cancer Institute
City
Rome
ZIP/Postal Code
00144
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
giuseppe sanguineti, Professor
Phone
0652661530
Email
giuseppe.sanguineti@ifo.it
First Name & Middle Initial & Last Name & Degree
Paola Franzoso, DM
Phone
0652666125
Email
paola.franzoso@ifo.it

12. IPD Sharing Statement

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Sbrt±sTad for Unfavorable iNtermediate rIsk/High Risk Prostate caNcer

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