SRT Versus SRT+ADT in Prostate Cancer

NCT05019846 | Recruiting Phase 3 DMC

• 2 other identifiers: SPA Trial vers. 1.12020-005754-23
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

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

Keywords

SRT; ADT; SBRT; high risk prostate cancer; unfavourable intermediate risk prostate cancer; randomized trial

Outcome Measures

Primary Outcomes (1)

• 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.

  outcome will be evaluated at the completion of 5 years of follow-up

Secondary Outcomes (11)

• Disease free survival

  outcome will be evaluated at the completion of 5 years of follow-up

• 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

• freedom from distant metastasis

  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

Study Arms (2)

SRT+ADT

EXPERIMENTAL

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

Drug: Triptorelin Embonate; Drug: Bicalutamide 50 mg

SRT alone

NO INTERVENTION

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).

Interventions

Triptorelin Embonate DRUG

single administration before SRT starting

SRT+ADT

Bicalutamide 50 mg DRUG

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

SRT+ADT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: prostate cancer patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Marco Lorenzo Bonu: lead
• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: collaborator

Study Sites (1)

ASST Spedali Civili of Brescia

Brescia, BS, 25123, Italy

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Triptorelin Pamoate; bicalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Luca Triggiani, MD PHD

  Università degli Studi di Brescia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Lorenzo Bonù, MD

CONTACT

+390303995285; marco.bonu@unibs.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Scientific coordinator

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 25, 2021
• Study Start: September 30, 2021
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Concurrently with the publication of study results concerning efficacy, we will deliver a completely deidentified data set to an appropriate data archive for sharing purposes.
• Access Criteria: explicit request

Locations

IT (1)