- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05557604
Sbrt±sTad for Unfavorable iNtermediate rIsk/High Risk Prostate caNcer (STUNNIN)
September 23, 2022 updated by: Giuseppe Sanguineti, Regina Elena Cancer Institute
Sbrt±sTad for Unfavorable iNtermediate rIsk/High Risk Prostate caNcer (STUNNIN): A Randomized Phase II Study
This is a prospective, open, randomized phase II trial.
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
146
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Giuseppe Sanguineti, Professor
- Phone Number: 0652663015
- Email: giuseppe.sanguineti@ifo.it
Study Locations
-
-
-
Rome, Italy, 00144
- Recruiting
- Regina Elena National Cancer Institute
-
Contact:
- giuseppe sanguineti, Professor
- Phone Number: 0652661530
- Email: giuseppe.sanguineti@ifo.it
-
Contact:
- Paola Franzoso, DM
- Phone Number: 0652666125
- Email: paola.franzoso@ifo.it
-
-
Lazio
-
Rome, Lazio, Italy, 00144
- Recruiting
- IFO Regina Elena
-
Contact:
- giuseppe sanguineti, Professor
- Phone Number: 0652661530
- Email: giuseppe.sanguineti@ifo.it
-
Contact:
- Paola Franzoso, DM
- Phone Number: 0652666125
- Email: paola.franzoso@ifo.it
-
-
RM
-
Rome, RM, Italy, 00144
- Recruiting
- IFO Regina Elena
-
Contact:
- giuseppe sanguineti, Professor
- Phone Number: 0652661530
- Email: giuseppe.sanguineti@ifo.it
-
Contact:
- Paola Franzoso, data manager
- Phone Number: 0652666125
- Email: paola.franzoso@ifo.it
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: arm 1
SBRT alone 38 GY in 4 fractions
|
|
Experimental: arm 2
SBRT along with short course (6 months) androgen deprivation (STAD)
|
STAD androgen deprivation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
3-yr bNED survival
Time Frame: 3 years
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 2, 2021
Primary Completion (Anticipated)
February 2, 2024
Study Completion (Anticipated)
February 2, 2027
Study Registration Dates
First Submitted
September 23, 2022
First Submitted That Met QC Criteria
September 23, 2022
First Posted (Actual)
September 28, 2022
Study Record Updates
Last Update Posted (Actual)
September 28, 2022
Last Update Submitted That Met QC Criteria
September 23, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Hormonal
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptive Agents, Female
- Luteolytic Agents
- Triptorelin Pamoate
Other Study ID Numbers
- RS1399/20(2384) PU
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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