Stereotactic Prostate Radiotherapy With or Without Androgen Deprivation Therapy, a Phase III, Multi-institutional Randomized-controlled Trial. The SPA Trial.
Overview
- Phase
- Phase 3
- Intervention
- Triptorelin Embonate
- Conditions
- Prostate Cancer
- Sponsor
- Marco Lorenzo Bonu
- Enrollment
- 310
- Locations
- 1
- Primary Endpoint
- biochemical disease free survival
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Marco Lorenzo Bonu
MD, Scientific coordinator
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Eligibility 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
- •Eastern Coooperative Oncology Group (ECOG) PS 0-2
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
Arms & Interventions
SRT+ADT
Patients in ARM A will be treated with SRT on the prostate (consecutive days or at alternate days to a total dose of 36.25 Gy administered in 5 fraction (7.25 Gy/fraction) + LHRH analogue (Triptoreline 22.5 mg). An anti-androgen drug (es. Bicalutamide 50 mg) must be administered daily starting from 7 days before LHRH analogue administration to 10 days after to prevent the flare effect
Intervention: Triptorelin Embonate
SRT+ADT
Patients in ARM A will be treated with SRT on the prostate (consecutive days or at alternate days to a total dose of 36.25 Gy administered in 5 fraction (7.25 Gy/fraction) + LHRH analogue (Triptoreline 22.5 mg). An anti-androgen drug (es. Bicalutamide 50 mg) must be administered daily starting from 7 days before LHRH analogue administration to 10 days after to prevent the flare effect
Intervention: Bicalutamide 50 mg
Outcomes
Primary Outcomes
biochemical disease free survival
Time Frame: outcome will be evaluated at the completion of 5 years of follow-up
form the date of the end of radiotherapy to the date of PSA meeting protocol criteria for biochemical relapse or last Follow-up visit. Outcome is mesured in months.
Secondary Outcomes
- freedom from local recurrence(outcome will be evaluated at the completion of 5 years of follow-up)
- freedom from regional recurrence(outcome will be evaluated at the completion of 5 years of follow-up)
- Overall survival(outcome will be evaluated at the completion of 5 years of follow-up)
- quality of life, prostate related quality of life in prostate cancer(12 weeks after SRT, 3, 6 and 12 months after SRT)
- Disease free survival(outcome will be evaluated at the completion of 5 years of follow-up)
- quality of life, prostate related quality of life questionnarire(12 weeks after SRT, 3, 6 and 12 months after SRT)
- patients reported outcome, prostate related symptoms assessment(12 weeks after SRT, 3, 6 and 12 months after SRT)
- freedom from distant metastasis(outcome will be evaluated at the completion of 5 years of follow-up)
- patients reported outcome, erectile function assessment,(12 weeks after SRT, 3, 6 and 12 months after SRT)
- Clinician reported Acute Toxicity, assessed with CTCAE 5.0 scales(from the beginning of treatment until 6 months after SRT)
- Clinician reported Late Toxicity, assessed with CTCAE 5.0 scales(from 6 months after SRT 5 years of follow-up)