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Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 to 80 Men only

Comparing Stereotactic Radiotherapy with and without Androgen Deprivation Therapy for Prostate Cancer

Official title: Stereotactic Prostate Radiotherapy With or Without Androgen Deprivation Therapy, a Phase III, Multi-institutional Randomized-controlled Trial. The SPA Trial.

Run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · NCT05019846 · Data updated 2026-11-12

This study is testing whether adding a short course of hormone therapy to targeted radiation treatment can help men with certain types of prostate cancer live longer without the disease coming back.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years to 80 Years
SexMen only
Enrollment310 (estimated)
SponsorAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Academic / other
Locations1 site (Brescia, BS)
StatusRecruiting
StartedSeptember 30, 2021
Main results expectedDecember 1, 2025
Study endsDecember 1, 2029
Registry record updatedApril 18, 2023
Trial IDNCT05019846 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include men diagnosed with prostate acinar adenocarcinoma who fall into the intermediate unfavorable or specific high-risk categories as defined by the D'Amico/NCCN classification.

Probably not a fit

Patients with low-risk prostate cancer or those who do not meet the specific eligibility criteria outlined in the study will likely not benefit from this trial.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of short-term Androgen Deprivation Therapy (ADT) in combination with Stereotactic Radiotherapy (SRT) for patients with intermediate unfavorable and certain high-risk prostate cancer. The study will randomly assign participants to receive either SRT alone or SRT plus 6 months of ADT, assessing outcomes such as biochemical disease-free survival. The trial seeks to clarify the potential benefits of adding ADT to SRT in these specific patient populations, which remains uncertain in current clinical practice.

Why it matters

Potential benefit: If successful, this study could improve treatment outcomes and survival rates for patients with high-risk and intermediate unfavorable prostate cancer.

How similar studies have gone: Previous studies have shown promising results for the combination of ADT and radiotherapy in prostate cancer, suggesting that this approach may be beneficial, although this specific combination with SRT is being evaluated for the first time.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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.
* 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
* Active severe inflammatory bowel disease
* Bilateral hip prothesis or any implant that could seriously interfere with dosimetric calculations
* Age \>80 years.
* cT4a, cT3b or pelvic lymph node involvement
* Controindication or hypersensitivity to the use of Triptoreline
* 5alpha reductase inhibitors not discontinued 4 weeks prior to randomization
* 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

Where it's running

  • ASST Spedali Civili of Brescia
    Brescia, Bs, Italy     Recruiting

Study contacts

  • Principal investigator: Luca Triggiani, MD PHD — Università degli Studi di Brescia
  • Study coordinator: Marco Lorenzo Bonù, MD
  • Email: marco.bonu@unibs.it
  • Phone: +390303995285

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.