Stereotactic hypofractionated radiotherapy with or without hormonal therapy in prostate cancer patients

Sbrt±sTad for Unfavorable iNtermediate rIsk/high risk prostate caNcer (STUNNIN): A Randomized Phase II Study - STUNNIN

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-004195-17-IT

Enrollment

146

Registered

2021-05-24

Start date

2021-01-26

Completion date

Unknown

Last updated

2022-03-02

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

Conditions

Unfavorable intermediate/high risk prostae cancer patients MedDRA version: 21.0 Level: LLT Classification code 10036946 Term: Prostatic cancer System Organ Class: 100000004864

Interventions

Product Name: Enantone 3,75 mg/2ml polvere Product Code: [027066125] Pharmaceutical Form: Powder and solvent for dispersion for injection INN or Proposed INN: LEUPROLIDE ACETATO Current Sponsor code:

Eligibility

Sex/Gender

Male

Inclusion 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; Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 56 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 90

Exclusion criteria

Exclusion criteria: T3b disease according to the 8th AJCC classification; - PSA>20 ng/ml at any time point - Gleason Score of 9 or 10 (Grade Grouping V) - 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
Main Objective: 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 Objective: Overall survival (OS) at 3 years - Prostate positive biopsy rates at 2 yrs - Metastases free survival at 3 yrs - Cumulative incidence of either GI/GU toxicity at 3 yrs (CTCAE v4.0) - Nadir PSA at various time points - Quality of Life at various time points (EORTC QLQ-C30 & FACT-P) - Erectile function at various time points (IIF-5) - Urinary Continence at various time points (ICIQ-Sf) - IPSS at various time points - Patient satisfaction with treatment at 3 yrs (FACIT-TS-G);Primary end point(s): The primary objective of the study is 3-yr bNED survival.;Timepoint(s) of evaluation of this end point: 3 years after randomization	—

Measure

Time frame

Main Objective: 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 Objective: Overall survival (OS) at 3 years - Prostate positive biopsy rates at 2 yrs - Metastases free survival at 3 yrs - Cumulative incidence of either GI/GU toxicity at 3 yrs (CTCAE v4.0) - Nadir PSA at various time points - Quality of Life at various time points (EORTC QLQ-C30 & FACT-P) - Erectile function at various time points (IIF-5) - Urinary Continence at various time points (ICIQ-Sf) - IPSS at various time points - Patient satisfaction with treatment at 3 yrs (FACIT-TS-G);Primary end point(s): The primary objective of the study is 3-yr bNED survival.;Timepoint(s) of evaluation of this end point: 3 years after randomization

—

Secondary

Measure	Time frame
Secondary end point(s): Overall survival;Timepoint(s) of evaluation of this end point: 3 years after randomization	—

Countries

Italy

Contacts

Public ContactUOC RADIOTERAPIA

ISTITUTI FISIOTERAPICI OSPITALIERI

paola.franzoso@ifo.gov.it0652666125

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026