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

Prostate Cancer Clinical Trial

— STUNNIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05557604
• Other study ID #: RS1399/20(2384) PU
• Status: Recruiting
• Phase: Phase 2
• Start date: February 2, 2021
• Est. completion date: February 2, 2027

Study information

• Verified date: September 2022
• Source: Regina Elena Cancer Institute
• Contact: Giuseppe Sanguineti, Professor
• Phone: 0652663015
• Email: giuseppe.sanguineti[@]ifo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 146
• Est. completion date: February 2, 2027
• Est. primary completion date: February 2, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Decapeptyl
STAD androgen deprivation

Locations

Country	Name	City	State
Italy	Ifo Regina elena	Rome	Lazio
Italy	ifo Regina Elena	Rome	RM
Italy	Regina Elena National Cancer Institute	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Regina Elena Cancer Institute

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 years