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Metastatic Prostate CancerPhase 2ABIDONCT02036060

Abiraterone Acetate in Combination With Docetaxel After Disease Progression to Abiraterone Acetate in Metastatic Castration Resistant Prostate Cancer.

A Phase 2 study testing docetaxel 75 mg/m2 + prednisone 10 mg/d + abiraterone 1000 mg/d and docetaxel 75 mg/m2 + prednisone 10 mg/d in people with Metastatic Prostate Cancer, run by Spanish Oncology Genito-Urinary Group at 17 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Prostate cancer is the most frequently diagnosed non-skin cancer, and the second leading cause of men cancer death in the United States. Hormonal therapy remains a first-line treatment for metastatic prostate cancer. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Metastatic Prostate Cancer
What is being tested?
docetaxel 75 mg/m2 + prednisone 10 mg/d + abiraterone 1000 mg/d and docetaxel 75 mg/m2 + prednisone 10 mg/d
Could I receive a placebo?
No, everyone receives an active treatment
How many people
119 participants
Where
17 sitesSpain
Study dates
7 Feb 2014to Oct 2020
Phase
Phase 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

  • Willing and able to provide written informed consent
  • Male aged 18 years and above
  • Histologically or cytologically confirmed adenocarcinoma of the prostate.
  • Metastatic disease documented by positive bone scan or metastatic lesions other than liver or visceral metastasis on CT, MRI.
  • Prostate cancer progression to previous castration treatment documented by PSA according to PCWG2 or radiographic progression according to modified RECIST criteria or bone scan progression
  • Asymptomatic or mildly symptomatic from prostate cancer
Show all 17Show fewer
  • Surgically or medically castrated, with testosterone levels of < 50 ng/dL (< 2.0 nM).
  • Previous anti-androgen therapy and progression after withdrawal.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Hemoglobin >= 10.0 g/dL independent of transfusion
  • Platelet count >= 100,000/µL
  • Serum albumin >= 3.5 g/dL
  • Serum creatinine < 1.5 x ULN or a calculated creatinine clearance >= 60 mL/min
  • Serum potassium >= 3.5 mmol/L
  • Liver function: a. Serum bilirubin < 1.5 x ULN (except for patients with documented Gilbert's disease) b. AST or ALT < 2.5 x ULN
  • Life expectancy of at least 6 months
  • Patients who have partners of childbearing potential must be willing to use a method of birth control

Who cannot join

  • Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
  • Any chronic medical condition requiring a higher dose of corticosteroid than 10mg prednisone/prednisolone daily.
  • Pathological finding consistent with small cell carcinoma of the prostate
  • Liver or visceral organ metastasis
  • Known brain metastasis
  • Use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime within 4 weeks of Cycle 1 Day 1
Show all 21Show fewer
  • Prior cytotoxic chemotherapy or biologic therapy for the treatment of CRPC
  • Radiation therapy for treatment of the primary tumor within 6 weeks of Cycle 1, Day
  • Radiation or radionuclide therapy for treatment of metastatic CRPC
  • Previously treated with ketoconazole for prostate cancer for greater than 7 days
  • Prior systemic treatment with an azole drug (e.g. fluconazole, itraconazole) within 4 weeks of Cycle 1, Day 1
  • Prior flutamide (Eulexin) treatment within 4 weeks of Cycle 1, Day 1
  • Bicalutamide (Casodex), nilutamide (Nilandron) within 6 weeks of Cycle 1 Day 1
  • Uncontrolled hypertension (systolic BP >= 160 mmHg or diastolic BP >= 95 mmHg).
  • Active or symptomatic viral hepatitis or chronic liver disease
  • History of pituitary or adrenal dysfunction
  • Clinically significant heart disease
  • Atrial Fibrillation, or other cardiac arrhythmia requiring therapy
  • Other malignancy, except non-melanoma skin cancer, with a >= 30% probability of recurrence within 24 months
  • Administration of an investigational therapeutic within 30 days of Cycle 1, Day 1
  • Any condition which, in the opinion of the investigator, would preclude participation in this trial.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

Spain17 sites

  • Hospital Universitari Germans Trias I Pujol

    Badalona, Barcelona, 08916

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, 08025

  • Hospital Clinic I Provincial de Barcelona

    Barcelona, 08036

  • Consorcio Hospitalario Provincial de Castellón

    Castellon, Castellón, 12002

  • Complejo Hospitalario Regional Reina Sofía

    Córdoba, 14004

  • Hospital Universitario de Guadalajara

    Guadalajara, 19002

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Ramón Y Cajal

    Madrid, 28034

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Virgen de La Victoria

    Málaga, 29010

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33006

  • Hospital Universitari Son Espases

    Palma de Mallorca, Balearic Islands, 07120

  • Complejo Hospitalario Regional Virgen Del Rocio

    Seville, 41013

  • Fundación Instituto Valenciano de Oncología

    Valencia, 46009

  • Complexo Hospitalario Universitario de Vigo

    Vigo, Pontevedra, 36036

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

About this study

Official title: Abiraterone Acetate Maintenance in Combination With Docetaxel After Disease Progression to Abiraterone Acetate in Metastatic Castration Resistant Prostate Cancer. Randomized Phase II Study.

Prostate cancer is the most frequently diagnosed non-skin cancer, and the second leading cause of men cancer death in the United States. Hormonal therapy remains a first-line treatment for metastatic prostate cancer. Initial responses to hormonal therapy with chemical or surgical castration are quite favorable, however, most patients will progress to a castration-resistant phase of the disease. Docetaxel is the primary chemotherapeutic option for patients with mCRPC.

Abiraterone is a novel, selective, irreversible, and potent inhibitor of 17-[alpha]-hydroxylase/17,20-lyase (CYP17) enzymatic activity that has recently been demonstrated to further reduce testosterone levels in the blood to undetectable range (< 1 ng/dL) and is suggested to reduce de novo intratumor androgen synthesis. Abiraterone demonstrated activity in castration resistant prostate cancer patients previously treated with docetaxel chemotherapy. Recently, results of a phase III trial comparing abiraterone plus prednisone vs placebo plus prednisone in asymptomatic and without visceral metastasis, castration-resistant metastatic prostate cancer patients, demonstrated a better radiological progression free survival for abiraterone treated patients and a trend towards a better survival was clear for abiraterone treated patients.

No clinical evidence exists about efficacy of chemotherapy and antiandrogen therapy combination. All trials have been performed in patients in which LHRH agonist treatment was continued although there is not clear evidence about efficacy of hormonal treatment. Some retrospective studies suggest that androgen deprivation treatment should be maintained in chemotherapy treated patients. Abiraterone has been proved to suppress androgen levels to negative values, and to add efficacy to castration hormonal therapy. Combination of abiraterone with docetaxel chemotherapy seems promising adding efficacy to only docetaxel chemotherapy. A randomized phase II study comparing docetaxel + prednisone + abiraterone to docetaxel + prednisone in mCRPC in patients treated previously with abiraterone, seems promising to explore addition of efficacy to taxotere after abiraterone hormonal treatment.

Being tested
docetaxel 75 mg/m2 + prednisone 10 mg/d + abiraterone 1000 mg/d, docetaxel 75 mg/m2 + prednisone 10 mg/d
Keywords
Metastatic prostate cancer, Abiraterone acetate
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • docetaxel 75 mg/m2 + prednisone 10 mg/d + abiraterone 1000 mg/dDrug

    Also called Arm A

    Docetaxel 75 mg/m2 + prednisone 10 mg/d + abiraterone 1000 mg/d in 21 day cycles.

  • docetaxel 75 mg/m2 + prednisone 10 mg/dDrug

    Also called Arm B

    Docetaxel 75 mg/m2 plus prednisone 10 mg/d in 21 day cycles.

Study groups in NCT02036060
Study groupRoleWhat they receive
Arm AExperimentaldocetaxel 75 mg/m2 + prednisone 10 mg/d + abiraterone 1000 mg/d
Receives: Drug: docetaxel 75 mg/m2 + prednisone 10 mg/d + abiraterone 1000 mg/d
Arm BActive comparatordocetaxel 75 mg/m2 + prednisone 10 mg/d
Receives: Drug: docetaxel 75 mg/m2 + prednisone 10 mg/d

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1 year radiologic progression free survival

    Time from randomization to radiologic disease progression

    Measured: 1 year

Secondary outcomes (10)

  1. Overall survival

    Time from randomization to death

    Measured: Up to 3 years

  2. Radiologic progression free survival

    Time from randomization to radiologic progression free survival

    Measured: Up to 1 year

  3. PSA progression free survival

    Time from randomization to PSA progression

    Measured: Up to 3 weeks

  4. PSA response rate

    50% \& 90% PSA reduction from randomisation

    Measured: Up to 3 weeks

  5. Objective response rate

    Response according RECIST criteria

    Measured: Up to 12 weeks

  6. Quality of life rate

    Quality of life according to FACT-P questionaire

    Measured: Up to 12 weeks

  7. Time to skeletal-related event

    Time from randomization to skeletal-related events

    Measured: Up to 12 weeks

  8. Time to opiate use for cancer pain

    Time from randomization to opiate use for cancer pain

    Measured: Up to 3 weeks

  9. Time to pain progression

    Time from randomization to pain progression defined as an increase in median BPI score ≥ 30% from baseline

    Measured: Up to 3 weeks

  10. Safety profile

    Related adverse events per patient

    Measured: Up to 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2014 (estimated)
  2. Study start7 Feb 2014
  3. Primary completionJun 2020
  4. Study completionOct 2020

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
119 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02036060
Sponsor's protocol ID
ABIDO-SOGUG
Other IDs
2013-003811-23
Acronym
ABIDO
Status last verified
Oct 2020
First submitted
10 Jan 2014
Last updated
16 Nov 2020
Results posted
No
Data monitoring committee
No

Publications

  • Climent MA, Font A, Duran I, Puente J, Jose Mendez-Vidal M, Saez MI, Santander Lobera C, Angel Arranz Arija J, Gonzalez-Del-Alba A, Sanchez-Hernandez A, Juan Fita MJ, Esteban E, Alonso-Gordoa T, Mellado Gonzalez B, Maroto P, Lazaro-Quintela M, Cassinello-Espinosa J, Perez-Valderrama B, Garcias C, Castellano D. A phase II randomised trial of abiraterone acetate plus prednisone in combination with docetaxel or docetaxel plus prednisone after disease progression to abiraterone acetate plus prednisone in patients with metastatic castration-resistant prostate cancer: The ABIDO-SOGUG trial. Eur J Cancer. 2022 Nov;175:110-119. doi: 10.1016/j.ejca.2022.08.002. Epub 2022 Sep 11.

    PubMed 36099670

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing docetaxel 75 mg/m2 + prednisone 10 mg/d + abiraterone 1000 mg/d and docetaxel 75 mg/m2 + prednisone 10 mg/d in people with Metastatic Prostate Cancer, run by Spanish Oncology Genito-Urinary Group at 17 sites in Spain.

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 21 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 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Spain. 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 phase mean?

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?

1 year radiologic progression free survival (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02036060, which also lists 1 linked publication.

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 16 Nov 2020.

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