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

NCT05557604 | Recruiting Phase 2

• 1 other identifier: RS1399/20(2384) PU
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Prostate Cancer

Keywords

neoplasm, prostate cancer,

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

arm 1

NO INTERVENTION

SBRT alone 38 GY in 4 fractions

arm 2

EXPERIMENTAL

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

Drug: Decapeptyl

Interventions

Decapeptyl DRUG

STAD androgen deprivation

Also known as: Enantone

arm 2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead

Study Sites (3)

Ifo Regina elena

Rome, Lazio, 00144, Italy

RECRUITING

ifo Regina Elena

Rome, RM, 00144, Italy

RECRUITING

Regina Elena National Cancer Institute

Rome, 00144, Italy

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Interventions

Triptorelin Pamoate; Leuprolide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Central Study Contacts

Giuseppe Sanguineti, Professor

CONTACT

0652663015; giuseppe.sanguineti@ifo.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professore

Model Details: prospective, open, randomized phase 2 trial

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: September 28, 2022
• Study Start: February 2, 2021
• Primary Completion: February 2, 2024
• Study Completion (Estimated): February 2, 2027
• Last Updated: September 28, 2022

Record last verified: 2022-09

Locations

IT (3)