Combined, Intensified and Modulated Adjuvant Therapy in Prostate Carcinoma

NCT ID: NCT03169933

Last Updated: 2018-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-02
• Study Completion Date: 2017-01-02

Brief Summary

Patients with high risk prostate cancer may benefit from radiotherapy after radical prostatectomy. The investigators postulated that adjuvant androgen deprivation therapy (ADT), radiation dose escalation, and selective pelvic irradiation may improve outcome. A phase II trial was designed to prove that combined-intensified-modulated-adjuvant (CIMA) treatment may improve 5-year biochemical relapse free survival (bRFS) from 75% to 90% in high risk patients. The delivered dose to tumor bed and pelvic nodes was 64.8-70.2 Gy and 45 Gy (57% of patients), respectively, and 69% received ADT.

Detailed Description

Prostate cancer patients at high risk of loco-regional recurrences may benefit from postoperative radiotherapy (RT) following radical prostatectomy (EORTC trial 22911). However, despite an improvement in biochemical relapse-free survival (bRFS), the risk of recurrences remained high for those patients. The investigators postulated that adjuvant androgen deprivation therapy (ADT), radiation dose escalation, and selective pelvic irradiation for patients at risk for regional failures may improve the outcome. The combined-intensified-modulated-adjuvant (CIMA) as described may improve survival through a reduction of loco-regional and systemic failures.

A phase II trial was designed to test the hypothesis that CIMA treatment may improve 5-year bRFS by 15%. Patients less than 80 years old, with a histological diagnosis of prostate adenocarcinoma without distant metastases, stage pT2-4 N0-1, no previous treatments and an ECOG performance status of 0-2 were selected. All patients had at least one of these pathologic features: extracapsular extension, positive surgical margins, or seminal vesicle invasion. Radiation dose to the tumor bed ranged from 64.8 to 70.2 Gy. Pelvic lymph nodes were treated to 45 Gy in selected patients at risk of regional failures (57%). Selected patients at risk for distant metastases (69.1%) received hormonal therapy.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

intensified and modulated adjuvant RT

All patients underwent combined, intensified and modulated adjuvant radiotherapy for 5 days a week with the following doses: 1) pelvic node irradiation (45 Gy; 1.8 Gy/fraction) followed by boost on the prostate bed (19.8-25.2 Gy; 1.8 Gy/fraction; total dose: 64.8-70.2 Gy) or 2) exclusive prostate bed irradiation (64.8 -70.2 Gy; 1.8 Gy/fraction).

Group Type: OTHER

Combined, intensified and modulated adjuvant radiotherapy

Intervention Type: RADIATION

Interventions

Combined, intensified and modulated adjuvant radiotherapy

Intervention Type: RADIATION

Other Intervention Names

adjuvant androgen deprivation therapy

Eligibility Criteria

Inclusion Criteria

• < 80 years old
• histological diagnosis of prostate adenocarcinoma
• no distant metastases
• stage pT2-4
• N0-1
• ECOG performance status of 0-2
• One of these pathologic features: extracapsular extension, positive surgical margins, or seminal vesicle invasion. extracapsular extension, positive surgical margins or seminal vesicle invasion, or positive lymph-nodes
• No surgical complications such as pelvic infections or lymphocele, intraoperative rectal injury or severe urinary incontinence
• Preoperative and postoperative PSA test, bone scan and CT-scan or MRI of abdomen and pelvis prior to enrolment
• Normal bone marrow function

Exclusion Criteria

• Previously treated with Radiotherapy
• Previously treated with androgen deprivation therapy
• Previously treated with chemotherapy for prostate cancer. They also had to be free

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Catholic University of the Sacred Heart

OTHER

Sponsor Role: collaborator

Howard University

OTHER

Sponsor Role: collaborator

University of Bologna

OTHER

Sponsor Role: collaborator

Michigan State University

OTHER

Sponsor Role: collaborator

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Alessio Giuseppe Morganti

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alessio G Morganti, MD

Role: STUDY_DIRECTOR

Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy

References

Mantini G, Siepe G, Alitto AR, Buwenge M, Nguyen NP, Farioli A, Schiavina R, Catucci F, Deodato F, Fionda B, Frascino V, Macchia G, Ntreta M, Padula GDA, Arcelli A, Cammelli S, Rambaldi GZ, Cilla S, Valentini V, Morganti AG. Tailored postoperative treatment of prostate cancer: final results of a phase I/II trial. Prostate Cancer Prostatic Dis. 2018 Nov;21(4):564-572. doi: 10.1038/s41391-018-0064-7. Epub 2018 Jul 23.

Reference Type: DERIVED

PMID: 30038390 (View on PubMed)

Other Identifiers

CIMA-1

Identifier Type: -

Identifier Source: org_study_id