Radiotherapy Plus Hormone Therapy in Biochemically-relapsing Prostate Cancer Patients Following Surgery

NCT01780220 | Completed Phase 1 DMC

• 2 other identifiers: GEP12-UC-0101/11042011-004831-30
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 5

Brief Summary

As there is no prospective data on the combination of abiraterone and salvage radiotherapy, the aim of this study is to further evaluate the safety profile of abiraterone acetate plus prednisone in patients with prostate cancer who are biochemically relapsing after surgery and undergo salvage radiotherapy with 6-months LH-RH agonist. The investigators hypothesize that the toxicity profile of both treatments should not potentiate each other. This study will also provide preliminary data on the efficacy of this combination.

Conditions

Biochemically-relapsing Prostate Adenocarcinoma Following Radical Prostatectomy

Keywords

abiraterone; biochemically-relapsing; prostate adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• to determine the maximum tolerated dose and the phase II recommended dose of abiraterone acetate treatment plus prednisone and LH-RH agonist combined with prostate radiotherapy

  within 11 weeks after Radiotherapy initiation

Secondary Outcomes (1)

• To evaluate the 3-year biochemical relapse-free survival

  3 years

Other Outcomes (1)

• overall safety profile

  3 years

Study Arms (1)

abiraterone

EXPERIMENTAL

Abiraterone acetate (three dose levels in phase I) + prednisone (10mg/day)+LHRH + Radiotherapy

Drug: Abiraterone

Interventions

Abiraterone DRUG

Abiraterone acetate 1000mg/day + prednisone alone for one month before initiating the sequence of radiotherapy

abiraterone

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed prostate adenocarcinoma
• The patients should have undergone only surgery for localized prostate adenocarcinoma: pT2, pT3 or pT4 with bladder neck involvement
• pN0: negative lymphadenectomy at the time of prostatectomy
• ≥ 18 years of age with life expectancy ≥ 10 years
• Performance Status (ECOG) ≤ 1
• PSA ≤ 0.1 ng/ml after prostatectomy (dosage performed within 2 months after surgery)
• Elevation of PSA over three consecutive assays performed in the same laboratory, with a minimal interval of two months between assays, (PSA nadir level followed by two other progressive assays)
• At least 6 months between surgery and biochemical relapse
• Serum potassium ≥ 3.5 mmol/L in the 72 hours before first dose of abiraterone acetate
• Serum creatinine \< 1.5 x ULN or a calculated creatinine clearance ≥ 60 mL/min
• Liver function:
• Serum bilirubin \< 1.5 x ULN (except for patients with documented Gilbert's disease) AST and ALT \< 2.5 x ULN
• Patients must be affiliated to a Social Security System.
• Patient information and written informed consent form signed for both principal and additional research
• Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures

You may not qualify if:

• pN1: histologically-proven lymph node involvement at initial lymphadenectomy
• Histology other than adenocarcinoma
• Previous hormone therapy including prior therapy with ketoconazole or other CYP17 inhibitor(s) for prostate cancer.
• Active or symptomatic viral hepatitis or chronic liver disease
• Surgical or chemical castration
• Previous pelvic radiotherapy
• Uncontrolled hypertension (defined as systolic BP ≥ 140 mmHg or diastolic BP ≥ 90 mmHg). Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy (see appendix 10 for mandatory BP measurement guidelines)
• Severe and moderate hepatic impairment (Child-Pugh class B and C)
• Patients with severe and/or uncontrolled medical disease which could compromise participation in the study, such as, but not limited to:
• Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease or cardiac ejection fraction measurement of \< 50 % at baseline
• Known hypersensitivity to any of the study drugs or excipients.
• Galactosemia, Glucose-galactose malabsorption or lactase deficiency
• Patients with any psychological, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
• Individual deprived of liberty or placed under the authority of a tutor.
• Patients already included in another therapeutic trial with an experimental drug or having been given an experimental drug within a period of 30 days.

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (5)

Institut Bergonié

Bordeaux, France

Location

Centre François Baclesse

Caen, France

Location

Centre Georges François Leclerc

Dijon, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Institut de Cancérologie de l'ouest/René Gauducheau

Saint-Herblain, 44805, France

Location

MeSH Terms

Interventions

abiraterone

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2013
• First Posted: January 30, 2013
• Study Start: December 1, 2012
• Primary Completion: January 7, 2022
• Study Completion: January 7, 2022
• Last Updated: May 19, 2022

Record last verified: 2022-05

Locations

FR (5)