Combined, Intensified and Modulated Adjuvant Therapy in Prostate Carcinoma

Prostate Cancer Clinical Trial

Official title:

Combined, Intensified and Modulated Adjuvant Therapy in Prostate Carcinoma: a Phase II Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03169933
• Other study ID #: CIMA-1
• Status: Completed
• Phase: N/A
• First received: May 17, 2017
• Last updated: March 5, 2018
• Start date: January 2, 2004
• Est. completion date: January 2, 2017

Study information

• Verified date: March 2018
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: January 2, 2017
• Est. primary completion date: January 10, 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Combined, intensified and modulated adjuvant radiotherapy

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi	Catholic University of the Sacred Heart, Howard University, Michigan State University, University of Bologna

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of early treatment-emergent adverse events	Adverse events after radiotherapy . Acute side effects were scored according to the Radiation Therapy Oncology Group (RTOG) scale.	< 90 days.
Secondary	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)	Late complications were assessed with the Late Radiation Morbidity Scoring Scheme of the RTOG/European Organization for Research and Treatment of Cancer (EORT)	5 years
Secondary	First evidence of any pelvic recurrence	First evidence of any pelvic recurrence	5 years
Secondary	Metastasis-free survival	The first evidence of any extra pelvic recurrence of disease.	5 years