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Trial Title:
Sbrt±sTad for Unfavorable iNtermediate rIsk/High Risk Prostate caNcer
NCT ID:
NCT05557604
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Triptorelin Pamoate
Conditions: Keywords:
neoplasm, prostate cancer,
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
prospective, open, randomized phase 2 trial
Primary purpose:
Supportive Care
Masking:
Single (Investigator)
Masking description:
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.
Intervention:
Intervention type:
Drug
Intervention name:
Decapeptyl
Description:
STAD androgen deprivation
Arm group label:
arm 2
Other name:
Enantone
Summary:
This is a prospective, open, randomized phase II trial.
Detailed 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.
Criteria for eligibility:
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;
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
Gender:
Male
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Ifo Regina elena
Address:
City:
Rome
Zip:
00144
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Giuseppe Sanguineti, Professor
Phone:
0652661530
Email:
giuseppe.sanguineti@ifo.it
Contact backup:
Last name:
Paola Franzoso, DM
Phone:
0652666125
Email:
paola.franzoso@ifo.it
Facility:
Name:
ifo Regina Elena
Address:
City:
Rome
Zip:
00144
Country:
Italy
Status:
Recruiting
Contact:
Last name:
giuseppe sanguineti, Professor
Phone:
0652661530
Email:
giuseppe.sanguineti@ifo.it
Contact backup:
Last name:
Paola Franzoso, data manager
Phone:
0652666125
Email:
paola.franzoso@ifo.it
Facility:
Name:
Regina Elena National Cancer Institute
Address:
City:
Rome
Zip:
00144
Country:
Italy
Status:
Recruiting
Contact:
Last name:
giuseppe sanguineti, Professor
Phone:
0652661530
Email:
giuseppe.sanguineti@ifo.it
Contact backup:
Last name:
Paola Franzoso, DM
Phone:
0652666125
Email:
paola.franzoso@ifo.it
Start date:
February 2, 2021
Completion date:
February 2, 2027
Lead sponsor:
Agency:
Regina Elena Cancer Institute
Agency class:
Other
Source:
Regina Elena Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05557604
