Combined, Intensified and Modulated Adjuvant Therapy in Prostate Carcinoma

NCT03169933 | Completed DMC

• 1 other identifier: CIMA-1
• Study Type: interventional
• Target: 123
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prostate Cancer

Keywords

adjuvant; androgen suppressive therapy; literature review; phase II; prostate neoplasms; radiotherapy

Outcome Measures

Primary Outcomes (1)

• Biochemical relapse free survival

  Survival free from increase of PSA level exceeding 0.2 ng/mL for those with postsurgical PSA level of 0.2 ng/mL or lower, and as two consecutive PSA increases for patients with a postsurgical PSA level of \> 0.2 ng/ml

  Five years

Secondary Outcomes (4)

• Incidence of early treatment-emergent adverse events

  < 90 days.

• Incidence of late treatment-emergent adverse events were assessed with Radiation Morbidity Scoring Scheme of the RTOG/European Organization for Research and Treatment of Cancer (EORT)

  5 years

• First evidence of any pelvic recurrence

  5 years

• Metastasis-free survival

  5 years

Study Arms (1)

intensified and modulated adjuvant RT

OTHER

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).

Radiation: Combined, intensified and modulated adjuvant radiotherapy

Interventions

Combined, intensified and modulated adjuvant radiotherapy RADIATION

Also known as: adjuvant androgen deprivation therapy

intensified and modulated adjuvant RT

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \< 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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead
• Catholic University of the Sacred Heart: collaborator
• Howard University: collaborator
• University of Bologna: collaborator
• Michigan State University: collaborator

Related Publications (1)

• 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.

  PMID: 30038390 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Alessio G Morganti, MD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: May 30, 2017
• Study Start: January 2, 2004
• Primary Completion: January 10, 2009
• Study Completion: January 2, 2017
• Last Updated: March 6, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share