Study on Prostate Cancer: Comparing Stereotactic Body Radiation Therapy Alone or with Triptorelin and Bicalutamide for Patients with Acinar Cell Prostatic Carcinoma

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What is this study about?

This clinical trial is focused on studying the treatment of prostate cancer, specifically a type called acinar cell prostatic carcinoma. The study is investigating the effects of a treatment called stereotactic body radiation therapy (SBRT), which is a precise form of radiation therapy that targets the prostate. The trial is examining whether adding androgen deprivation therapy (ADT) to SBRT improves outcomes for patients compared to using SBRT alone. ADT is a treatment that reduces male hormones, which can help slow the growth of prostate cancer.

Two medications are being used in this study. The first is Decapeptyl, which contains the active substance triptorelin and is administered as a prolonged-release injection under the skin. The second medication is Casodex, which contains the active substance bicalutamide and is taken orally as a film-coated tablet. These medications are part of the ADT treatment being tested in combination with SBRT.

The purpose of the study is to determine if there is an improvement in the time patients remain free from signs of cancer after treatment, known as biochemical disease-free survival (bDFS). Participants in the study will receive either SBRT alone or SBRT combined with ADT. The trial will monitor patients over time to assess the effectiveness of these treatments in preventing cancer recurrence and improving overall survival. The study is expected to continue until 2029.

1 initial treatment phase

The trial involves two groups: one receiving stereotactic body radiation therapy (SBRT) alone and the other receiving SBRT combined with androgen deprivation therapy (ADT).

If assigned to the group receiving ADT, the medication triptorelin is administered as a subcutaneous injection. This is a prolonged-release suspension for injection, given every six months.

Additionally, the medication bicalutamide is taken orally in the form of a film-coated tablet. The dosage is 50 mg daily.

2 radiation therapy

The stereotactic body radiation therapy (SBRT) is administered to the prostate. This is a precise form of radiation therapy aimed at targeting the cancer cells while minimizing exposure to surrounding healthy tissue.

3 monitoring and follow-up

Regular follow-up appointments are scheduled to monitor the response to treatment. This includes imaging tests and blood tests to measure prostate-specific antigen (PSA) levels.

The primary goal is to determine if there is an improvement in biochemical disease-free survival (bDFS), which is assessed by monitoring PSA levels.

4 completion of trial

The trial is expected to continue until November 28, 2029. During this time, ongoing assessments will be conducted to evaluate the effectiveness of the treatment.

Secondary outcomes include disease-free survival, freedom from local and regional recurrence, freedom from distant metastasis, and overall survival.

Who Can Join the Study?

Age between 18 and 80 years old.
Prostate size must be less than 100 cubic centimeters (cc).
PSA, a blood test for prostate health, must be done within 60 days before joining the study.
No cancer spread to lymph nodes or other parts of the body, as shown by specific scans like PET or CT scans.
Confirmation of prostate acinar adenocarcinoma, a type of prostate cancer, with at least 10 samples taken during a biopsy.
Undergo a special MRI scan of the prostate to check the local stage of cancer.
Belong to the intermediate unfavorable group based on certain risk factors, such as specific PSA levels, cancer grade, or percentage of positive biopsy samples.
Belong to a specific high-risk group based on certain criteria like cancer stage or PSA levels.
Have an ECOG performance status of 0-2, which means the patient is fully active or has some limitations but can still take care of themselves.
Ability to understand and sign a written consent form agreeing to participate in the study.
Willingness to complete questionnaires about their health during the study.
Have an IPSS score between 0 and 15, which measures urinary symptoms.

Who Cannot Join the Study?

Patients who are not male cannot participate in the study.
Patients who are under 18 years old or over 65 years old cannot participate in the study.
Patients with medical conditions other than Acinar cell prostatic carcinoma cannot participate. This is a specific type of prostate cancer.
Patients who are part of a vulnerable population, such as those who cannot make decisions for themselves, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
IRCCS Humanitas Research Hospital	Rozzano	Italy
Azienda Ospedaliero Universitaria Di Sassari	Sassari	Italy
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
Azienda Socio Sanitaria Territoriale Di Cremona	Cremona	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Azienda Socio Sanitaria Territoriale Della Valtellina E Dell Alto Lario	Sondrio	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Universita’ Degli Studi Di Verona	Verona	Italy
Cliniche Gavazzeni S.p.A.	Bergamo	Italy
Azienda Sanitaria Locale Cn2 Alba-Bra	Alba	Italy
Azienda Provinciale Per I Servizi Sanitari	Trento	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
Universita’ Degli Studi Di Ferrara	Ferrara	Italy
IRCCS Ospedale Sacro Cuore Don Calabria	Negrar di Valpolicella	Italy
IRCCS CROB	Rionero In Vulture	Italy
Care Db Ctbo Muealykcniwp Spttxl	Palermo	Italy
Ainykhk Uebbo Laztes Sqkoa Sttkmukxb Ng 1 Dotswsqr	Belluno	Italy
Ajskraw Scuewqnhv Lydnlm Dmlgs Pgpjibflt Di Lrxzn	Lecce	Italy
Afllnlj Sgvsw Srlydzmxc Tlakyzrzqxsh Dasjw Vwjapzeqqke	Breno	Italy
Aofuqzb Owrwzbwluux Ureiicehkutab Cgvgcomnqcno Dlgut Ssmzbv E Dwixy Swkmkyv Di Tbaujl	Turin	Italy
Aobhica Ojgnzajmzul Nxxbabgbd Sy Ahiykyh E Brlifx E C Ayqkyl Azuobqjhqkp	Alexandria	Italy
Azugswz Uqk Iyyoi Da Rngrjt Eebtjt	Reggio Emilia	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	28.12.2021

Trial locations

Investigated drugs:

Stereotactic Body Radiation Therapy (SBRT) is a type of radiation therapy that precisely targets cancer cells in the prostate. It uses advanced imaging techniques to deliver high doses of radiation to the tumor while minimizing damage to surrounding healthy tissue. This therapy is used to treat prostate cancer and aims to improve the control of the disease.

Androgen Deprivation Therapy (ADT) is a treatment that reduces the levels of male hormones, such as testosterone, in the body. These hormones can promote the growth of prostate cancer cells. By lowering hormone levels, ADT can help slow down or shrink the cancer, making it an important part of prostate cancer treatment.

Acinar cell prostatic carcinoma – This is a type of prostate cancer that originates in the acinar cells, which are responsible for producing the fluid part of semen. It is the most common form of prostate cancer. The disease typically progresses slowly, often without noticeable symptoms in the early stages. As it advances, it may cause urinary difficulties, such as increased frequency or difficulty in urination. In some cases, it can spread to other parts of the body, including bones and lymph nodes. The progression and symptoms can vary widely among individuals.

Trial ID:

2024-520093-34-00

Protocol code:

ASST-FRADIO-SPA-2020

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Prostate Cancer: Comparing Stereotactic Body Radiation Therapy Alone or with Triptorelin and Bicalutamide for Patients with Acinar Cell Prostatic Carcinoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?