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

Regina Elena Cancer Institute

Status and phase: Enrolling; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: Decapeptyl

Study type: Interventional

Funder types: Other

Identifiers

NCT05557604

RS1399/20(2384) PU

Details and patient eligibility

About

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

Full 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.

Enrollment: 146 estimated patients

Sex: Male

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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146 participants in 2 patient groups

arm 1

No Intervention group

Description:

SBRT alone 38 GY in 4 fractions

arm 2

Experimental group

Description:

SBRT along with short course (6 months) androgen deprivation (STAD)

Treatment:

Drug: Decapeptyl