Actively Recruiting
SRT Versus SRT+ADT in Prostate Cancer
Led by Marco Lorenzo Bonu · Updated on 2023-04-18
310
Participants Needed
1
Research Sites
426 weeks
Total Duration
On this page
Sponsors
M
Marco Lorenzo Bonu
Lead Sponsor
A
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Collaborating Sponsor
AI-Summary
What this Trial Is About
To clarify the role of short-term Androgen deprivation therapy (ADT) in the context of intermediate unfavorable and a subclass of high-risk patients treated with prostate Stereotactic radiotherapy (SRT). In intermediate unfavorable risk group, when choosing standard external beam radiotherapy, short term ADT is superior in terms of biochemical disease free survival (bDFS) to EBRT alone. In high risk disease, results of the combination therapy are even more clear. Prostate SRT has been endorsed as option for primary radical treatment for prostate cancer. In such patients, the benefit of ADT is still unknown and the decision is left to clinical judgement. For these reasons, it seems to be relevant to propose a randomized, open label, phase III clinical trial of prostate SBRT + 6 months ADT versus prostate SBRT alone in intermediate unfavorable and a subgroup of high risk prostate cancer patients.
CONDITIONS
Official Title
SRT Versus SRT+ADT in Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological confirmation of prostate acinar adenocarcinoma with at least 10 biopsy cores taken
- Prostate MRI for local staging
- Intermediate unfavorable risk group by D'Amico/NCCN classification with grade group 3 and/or 2-3 risk factors (PSA 10-20 ng/ml, grade group 2-3, clinical stage T2b-T2c) and/or biopsy cores positive ≥50%
- Subclass of high risk group by D'Amico/NCCN classification including ISUP group 4 (Gleason score 4+4, 3+5, 5+3), clinical stage T3a, or PSA >20
- Eastern Cooperative Oncology Group performance status 0-2
- Ability to understand and sign informed consent
- Willingness to comply with patient-reported outcome questionnaires
- International Prostate Symptom Score 0-15
- Prostate volume less than 100 cc
- PSA measured within 60 days before randomization
- No pathologic lymph nodes or distant metastasis on PET scan or CT and bone scan
- Contraceptive measures explained for patients with reproductive partners
You will not qualify if you...
- History of malignant tumors within past 2 years, except non-melanoma skin cancers, with disease-free period of at least 24 months
- Previous prostate surgery other than TURP at least 6 weeks before starting stereotactic radiotherapy
- Previous pelvic radiation therapy
- Prior androgen deprivation therapy except 5-alpha reductase inhibitors
- Any prior active treatment for prostate cancer except active surveillance if criteria met
- Active severe inflammatory bowel disease
- Bilateral hip prosthesis or implants interfering with radiation dose calculations
- Age over 80 years
- Clinical stage T4a, T3b, or pelvic lymph node involvement
- Contraindications or allergy to Triptorelin
- 5-alpha reductase inhibitors not stopped 4 weeks before randomization
- History of bone fractures or falls
- Risk factors for abnormal heart rhythms or QT prolongation
- Use of medications that prolong QT/QTc interval
AI-Screening
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Trial Site Locations
Total: 1 location
1
ASST Spedali Civili of Brescia
Brescia, BS, Italy, 25123
Actively Recruiting
Research Team
M
Marco Lorenzo Bonù, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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