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

Sbrt±sTad for Unfavorable iNtermediate rIsk/High Risk Prostate caNcer (STUNNIN): A Randomized Phase II Study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05557604

Acronym

STUNNIN

Enrollment

146

Registered

2022-09-28

Start date

2021-02-02

Completion date

2027-02-02

Last updated

2022-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

neoplasm, prostate cancer,

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.

Interventions

DRUGDecapeptyl

STAD androgen deprivation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (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.

Intervention model description

prospective, open, randomized phase 2 trial

Eligibility

Sex/Gender

MALE

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
3-yr bNED survival	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.

Countries

Italy

Contacts

Primary ContactGiuseppe Sanguineti, Professor

giuseppe.sanguineti@ifo.it0652663015

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026