Tests radiotherapy with or without short-term hormone therapy in prostate cancer
Compares stereotactic radiotherapy alone with radiotherapy plus hormone therapy in prostate cancer.
Plain-language title generated from the registry record
Registry title: SRT Versus SRT+ADT in Prostate Cancer
Key facts
- Where
- Brescia, ItalySee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with prostate cancer of intermediate unfavorable risk or a subgroup of high risk. All get stereotactic radiotherapy, and some also get 6 months of hormone therapy (ADT).
- Age
- 18 to 80 years
- Sex
- Men only
- Disease stage
- Prostate adenocarcinoma, intermediate unfavorable risk or a subgroup of high risk (ISUP group 4, cT3a stage, or PSA>20). No cancer in the pelvic lymph nodes and no distant spread on PET or CT plus bone scan.
- Earlier treatment
- No prior hormone therapy (ADT), no pelvic radiotherapy, and no prior active treatment for prostate cancer. No prostate surgery other than TURP. 5alpha reductase inhibitors must be stopped 4 weeks before randomization.
- Biomarker or test result
- PSA must be measured at most 60 days before randomization. No gene marker is asked for.
Main reasons for not taking part
- Other cancer in the previous 2 years (except non-melanoma skin cancer)
- Age over 80 years
- cT4a, cT3b stage or pelvic lymph node involvement
- Active severe inflammatory bowel disease
- Risk factors for abnormal heart rhythm or QT prolongation, or medicines that prolong the QT/QTc interval
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT05019846, who can take part
Where in Italy
- ASST Spedali Civili of BresciaBrescia, ItalyContact: Marco Lorenzo Bonù, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Marco Lorenzo Bonu
- Trial code
- NCT05019846
- Record updated
- 18 April 2023
- Original description
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).Read full original descriptionShow less
Stereotactic Prostate Radiotherapy With or Without Androgen Deprivation Therapy, a Phase III, Multi-institutional Randomized-controlled Trial. The SPA Trial.
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.
Inclusion: Histological confirmation of prostate acinar adenocarcinoma with a minimum of 10 biopsy cores taken; Prostate protocol MRI for local staging; Patients belonging to intermediate unfavorable group according to the D'Amico/NCCN risk group classification:; -Grade group 3 or/and; -2-3 risk factors for intermediate category (PSA 10-20 ng/ml/ Grade group 2-3/ cT2b cT2c) or/and; -biopsy cores positive ≥50%; Patients belonging to a subclass of high risk group according to the D'Amico/NCCN risk group classification:; -ISUP group 4 (GS 4+4, 3+5, 5+3) or; -cT3a stage or; PSA>20; Eastern Coooperative Oncology Group (ECOG) PS 0-2; Ability of the patient to understand and sign a written informed consent document; Ability and willingness to comply with patients reported outcome questionnaires schedule during the study time; IPSS 0-15; Prostate Volume less than 100cc; PSA must be dosed maximum 60 days before randomization; No pathologic lymph nodes and distant metastasis on PET (fluorocholine) scan or CT scan+bone scan; Contraceptive measures for patients with partners with reproductive potential must be explained.
Exclusion: Previous prostate surgery other than TURP (at least 6 weeks prior to start of SBRT); Previous pelvic RT; Prior androgen deprivation therapy (excluding 5alpha reductase inhibitors); Any prior active treatment for prostate cancer; patients on previous active surveillance are eligible if inclusion criteria are met; Bilateral hip prothesis or any implant that could seriously interfere with dosimetric calculations; 5alpha reductase inhibitors not discontinued 4 weeks prior to randomization; History of Malignant tumors in the previous 2 years excluding non melanoma cancers of the skin. If a patient presents an anamnesis of malignancy (excluding non melanoma skin cancers) it must be free from disease since 24 months at the time of enrollement; Active severe inflammatory bowel disease; Controindication or hypersensitivity to the use of Triptoreline; History of bone fractures and fall; Risk factors for abnormal heart rhythms or QT prolongation; Use of concomitant medications that prolong the QT/QTc interval; Age >80 years; cT4a, cT3b or pelvic lymph node involvement.