Comparing Stereotactic Radiotherapy with and without Androgen Deprivation Therapy for Prostate Cancer
Stereotactic Prostate Radiotherapy With or Without Androgen Deprivation Therapy, a Phase III, Multi-institutional Randomized-controlled Trial. The SPA Trial.
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
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 310 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Male |
| Sponsor | Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Academic / other |
| Locations | 1 site (Brescia, BS) |
| Trial ID | NCT05019846 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Brescia, BS
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.