Sbrt±sTad for Unfavorable iNtermediate rIsk/High Risk Pro... | NCT05557604

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

NCT05557604

Sponsor

Regina Elena Cancer Institute

Status

Recruiting

Last Update Posted

Sep 28, 2022Actual

Enrollment

146Estimated

Phase

Phase 2

Conditions

Prostate Cancer

Interventions

Decapeptyl

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2, 2021Actual

Primary Completion Date

Feb 2, 2024Estimated

Completion Date

Feb 2, 2027Estimated

First Submitted Date

Sep 23, 2022

First Submission Date that Met QC Criteria

Sep 23, 2022

First Posted Date

Sep 28, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 23, 2022

Last Update Posted Date

Sep 28, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

146Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
arm 1	No Intervention	SBRT alone 38 GY in 4 fractions
arm 2	Experimental	SBRT along with short course (6 months) androgen deprivation (STAD)	Drug: Decapeptyl

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Decapeptyl	Drug	STAD androgen deprivation	arm 2	Enantone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Giuseppe Sanguineti, Professor	Contact	0652663015		giuseppe.sanguineti@ifo.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ifo Regina elena	Recruiting	Rome	Lazio	00144	Italy

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms
D009369	Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D005832	Genital Diseases, Male

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017329	Triptorelin Pamoate
D016729	Leuprolide

Ancestor Terms

ID	Term
D007987	Gonadotropin-Releasing Hormone
D010906	Pituitary Hormone-Releasing Hormones
D007028	Hypothalamic Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Single

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.

Who Masked

Investigator