Prostate CancerPhase 2STUNNINNCT05557604
Sbrt±sTad for Unfavorable iNtermediate rIsk/High Risk Prostate caNcer
A Phase 2 study testing Decapeptyl in people with Prostate Cancer, run by Regina Elena Cancer Institute at 3 sites in Italy.
Trial summary
This is a prospective, open, randomized phase II trial. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Decapeptyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 3 sitesItaly
- Study dates
- 2 Feb 2021to 2 Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy3 sites, 3 recruiting
- Recruiting
Ifo Regina elena
Rome, Lazio, 00144
Giuseppe Sanguineti, Professor, 0652661530, giuseppe.sanguineti@ifo.it
Paola Franzoso, DM, 0652666125, paola.franzoso@ifo.it
- Recruiting
ifo Regina Elena
Rome, RM, 00144
giuseppe sanguineti, Professor, 0652661530, giuseppe.sanguineti@ifo.it
Paola Franzoso, data manager, 0652666125, paola.franzoso@ifo.it
- Recruiting
Regina Elena National Cancer Institute
Rome, 00144
giuseppe sanguineti, Professor, 0652661530, giuseppe.sanguineti@ifo.it
Paola Franzoso, DM, 0652666125, paola.franzoso@ifo.it
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Decapeptyl
- Keywords
- neoplasm, prostate cancer,
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DecapeptylDrug
Also called Enantone
STAD androgen deprivation
| Study group | Role | What they receive |
|---|---|---|
| arm 1 | No intervention | SBRT alone 38 GY in 4 fractions |
| arm 2 | Experimental | SBRT along with short course (6 months) androgen deprivation (STAD) Receives: Drug: Decapeptyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start2 Feb 2021
- Primary completion2 Feb 2024 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, open, randomized phase 2 trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Sanguineti, Regina Elena Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05557604
- Sponsor's protocol ID
- RS1399/20(2384) PU
- Acronym
- STUNNIN
- Status last verified
- Sep 2022
- First submitted
- 23 Sep 2022
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sbrt±sTad for Unfavorable iNtermediate rIsk/High Risk Prostate caNcer (STUNNIN): A Randomized Phase II Study
- ClinicalTrials.gov ID
- NCT05557604
- Acronym / sponsor ID
- STUNNIN / RS1399/20(2384) PU
- Conditions
- Prostate Cancer
- Keywords
- neoplasm, prostate cancer,
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 2 Feb 2024 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 28 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- prospective, open, randomized phase 2 trial
| Arm | Type | Receives |
|---|---|---|
| arm 1 | No intervention | –SBRT alone 38 GY in 4 fractions |
| arm 2 | Experimental | Drug: DecapeptylSBRT along with short course (6 months) androgen deprivation (STAD) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DecapeptylAlso: EnantoneSTAD androgen deprivation | Drug | arm 2 |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Decapeptyl in people with Prostate Cancer, run by Regina Elena Cancer Institute at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Sanguineti, Professor (0652663015, giuseppe.sanguineti@ifo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-yr bNED survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.