Biochemically-relapsing Prostate Adenocarcinoma Following Radical ProstatectomyPhase 1/2CARLHANCT01780220
Radiotherapy Plus Hormone Therapy in Biochemically-relapsing Prostate Cancer Patients Following Surgery
A Phase 1/2 study testing Abiraterone in people with Biochemically-relapsing Prostate Adenocarcinoma Following Radical Prostatectomy, run by UNICANCER at 5 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Biochemically-relapsing Prostate Adenocarcinoma Following Radical Prostatectomy
- What is being tested?
- Abiraterone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 5 sitesFrance
- Study dates
- Dec 2012to 7 Jan 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- At inclusion the patients should have no clinical signs of progressive disease and should be M0 (bone and pelvic scans).
- ≥ 18 years of age with life expectancy ≥ 10 years
- Performance Status (ECOG) ≤ 1
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- PSA ≤ 0.1 ng/ml after prostatectomy (dosage performed within 2 months after surgery)
- PSA ≥ 0.2 ng/ml et ≤ 2 ng/ml at the time of inclusion
- 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
Who cannot join
- 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.
- Patients being treated within the last 14 days prior to inclusion with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A4 (Clarithromycin, Ketoconazole, Itraconazole, Voriconazole, Ritanovir, see appendix 11) or requiring those treatments during the study
- Active or symptomatic viral hepatitis or chronic liver disease
- Surgical or chemical castration
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- History of cancer, with the exception of basal cell carcinoma or any other cancer treated in the 5 years before inclusion and in complete remission.
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Institut Bergonié
Bordeaux
Centre François Baclesse
Caen
Centre Georges François Leclerc
Dijon
Centre Leon Berard
Lyon, 69373
Institut de Cancérologie de l'ouest/René Gauducheau
Saint-Herblain, 44805
About this study
Official title: Safety and Efficacy of Radiotherapy Combined With a 6-month LH-RH Agonist and Abiraterone Hormone Therapy Treatment in Biochemically-relapsing Prostate Cancer Following Surgery
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.
- Being tested
- Abiraterone
- Keywords
- abiraterone, biochemically-relapsing, prostate adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbirateroneDrug
Abiraterone acetate 1000mg/day + prednisone alone for one month before initiating the sequence of radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| abiraterone | Experimental | Abiraterone acetate (three dose levels in phase I) + prednisone (10mg/day)+LHRH + Radiotherapy Receives: Drug: Abiraterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 11 weeks after Radiotherapy initiation
Secondary outcomes (1)
To evaluate the 3-year biochemical relapse-free survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startDec 2012
- Primary completion7 Jan 2022
- Study completion7 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biochemically-relapsing Prostate Adenocarcinoma Following Radical ProstatectomyStudies of the same condition, open and under way.
- More trials run by UNICANCERThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01780220
- Sponsor's protocol ID
- GEP12-UC-0101/1104
- Other IDs
- 2011-004831-30
- Acronym
- CARLHA
- Status last verified
- May 2022
- First submitted
- 29 Jan 2013
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Radiotherapy Combined With a 6-month LH-RH Agonist and Abiraterone Hormone Therapy Treatment in Biochemically-relapsing Prostate Cancer Following Surgery
- ClinicalTrials.gov ID
- NCT01780220
- Acronym / sponsor ID
- CARLHA / GEP12-UC-0101/1104
- Keywords
- abiraterone, biochemically-relapsing, prostate adenocarcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- Dec 2012 (actual)
- Primary completion
- 7 Jan 2022 (actual)
- Study completion
- 7 Jan 2022 (actual)
- First posted
- 30 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| abiraterone | Experimental | Drug: AbirateroneAbiraterone acetate (three dose levels in phase I) + prednisone (10mg/day)+LHRH + Radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
- At inclusion the patients should have no clinical signs of progressive disease and should be M0 (bone and pelvic scans).
- ≥ 18 years of age with life expectancy ≥ 10 years
Key exclusion criteria (17 listed)
- 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.
- Patients being treated within the last 14 days prior to inclusion with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A4 (Clarithromycin, Ketoconazole, Itraconazole, Voriconazole, Ritanovir, see appendix 11) or requiring those treatments during the study
- Active or symptomatic viral hepatitis or chronic liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbirateroneAbiraterone acetate 1000mg/day + prednisone alone for one month before initiating the sequence of radiotherapy | Drug | abiraterone |
Primary outcome
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
Time frame: within 11 weeks after Radiotherapy initiation
1 secondary outcome
To evaluate the 3-year biochemical relapse-free survival
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Abiraterone in people with Biochemically-relapsing Prostate Adenocarcinoma Following Radical Prostatectomy, run by UNICANCER at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: within 11 weeks after Radiotherapy initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.