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NCT Number: NCT05557604

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

This is a prospective, open, randomized phase II trial.

Recruiting

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Ifo Regina elena, Rome, Lazio, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Decapeptyl

Drug

STAD androgen deprivation

Other names: Enantone

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Giuseppe Sanguineti, Professor

CONTACT

[email protected]

0652663015

Sponsors and collaborators

Lead sponsor

Regina Elena Cancer Institute

Other

Registry information

Official study title

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

Acronym: STUNNIN

Important dates

Study start
2021
Primary completion
2024
Study completion
2027
First posted
Sep 28, 2022
Registry last updated
Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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