SRT Versus SRT+ADT in Prostate Cancer

NCT ID: NCT05019846

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 310 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2029-12-01

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Triptorelin Embonate

Intervention Type: DRUG

single administration before SRT starting

Bicalutamide 50 mg

Intervention Type: DRUG

1 dose each day, 7 days before LHRH until 10 days after LHRH administration

SRT alone

Patients in ARM B will be treated with SRT on prostate alone at a total dose of 36.25 Gy administered daily or on alternate days in 5 fraction (7.25 Gy/fraction).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Triptorelin Embonate

single administration before SRT starting

Intervention Type: DRUG

Bicalutamide 50 mg

1 dose each day, 7 days before LHRH until 10 days after LHRH administration

Intervention Type: DRUG

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
• 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
• 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

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

OTHER

Sponsor Role: collaborator

Marco Lorenzo Bonu

OTHER

Sponsor Role: lead

Responsible Party

Marco Lorenzo Bonu

MD, Scientific coordinator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Luca Triggiani, MD PHD

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Brescia

Locations

ASST Spedali Civili of Brescia

Brescia, BS, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Marco Lorenzo Bonù, MD

Role: CONTACT

marco.bonu@unibs.it

+390303995285

Facility Contacts

Marco Lorenzo Bonù, MD

Role: primary

dm.radioterapiabs@gmail.com

+390303995285

Other Identifiers

2020-005754-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SPA Trial vers. 1.1

Identifier Type: -

Identifier Source: org_study_id