SRT Versus SRT+ADT in Prostate Cancer

Phase 3RecruitingNCT05019846

Marco Lorenzo Bonu310 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

310

Conditions

Prostate Cancer

Interventions

Eligibility

Sex: MALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

biochemical disease free survival

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.