RecruitingPhase 3NCT05019846

SRT Versus SRT+ADT in Prostate Cancer

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

Sponsor

Marco Lorenzo Bonu

Enrollment

310 participants

Start Date

Sep 30, 2021

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

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.

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 80 Years

Inclusion Criteria27

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
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
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
alpha 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

Exclusion Criteria4

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)