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Castration-resistant Prostate CancerPhase 2/3PRECHOLNCT01981707

F-choline PET in Early Response Assessment for Castration Resistant Prostatic Cancer

A Phase 2/3 study testing F-Choline-PET in people with Castration-resistant Prostate Cancer, run by University Hospital, Grenoble at 3 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Until today no current diagnostic tool exists to identify an early objective response when patients with castration-resistant prostate cancer were treated by abiraterone acetate or enzalutamide. According to the Prostate Cancer Working Group, the investigators have to wait 12 weeks before the first evaluation. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Castration-resistant Prostate Cancer
What is being tested?
F-Choline-PET
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
3 sitesFrance
Study dates
Dec 2013to Mar 2016
Phase
Phase 2/3
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

  • Age > 18 years
  • Eastern Cooperative Oncology Group (ECOG)performance status score of 2 or less
  • Histologically or cytologically confirmed adenocarcinoma prostate cancer without neuroendocrine component (component with minority neuroendocrine) or small cell, or neuroendocrine cells or small minority component prostate who underwent surgical or medical castration
  • Disease progression during or after a docetaxel-based chemotherapy
  • serum testosterone level of 50 ng per deciliter or less (≤2.0 nmol per liter)
  • Biologic criteria :
Show all 11Show fewer
  • platelets ≥ 100 000/μl,
  • Creatinine <1.5 x upper limit or creatinine clearance ≥ 60 ml / min,
  • Serum potassium ≥ 3.5 mmol / l,
  • Bilirubin <1.5 x upper limit of normal (ULN)
  • hemoglobin ≥ 9.0 g / dl without any transfusion.

Who cannot join

  • abnormal aminotransferase levels (levels of aspartate aminotransferase or alanine aminotransferase that were ≥2.5 times the upper level of the normal range; patients with known liver metastasis who had levels of aspartate aminotransferase or alanine aminotransferase that were ≤5 times the upper level of the normal range were eligible to participate
  • previous therapy with ketoconazole
  • serious coexisting nonmalignant disease :
  • active or symptomatic viral hepatitis or chronic liver disease,
  • uncontrolled hypertension,
  • a history of pituitary or adrenal dysfunction,
  • clinically significant heart disease

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • Clinique Universitaire d'Oncologie Médicale, CHU de Grenoble

    Grenoble, 38 000

  • Clinique Universitaire de Médecine Nucléaire, CHU de Grenoble

    Grenoble, 38 000

  • Service d'Oncologie Médicale, Institut Daniel Hollard, Groupement Hospitalier Mutualiste

    Grenoble, 38 000

Other trials in France

About this study

Official title: F-choline PET in Early Response Assessment for Castration Resistant Prostatic Cancer Treated by Abiraterone Acetate or Enzalutamide

Until today no current diagnostic tool exists to identify an early objective response when patients with castration-resistant prostate cancer were treated by abiraterone acetate or enzalutamide. According to the Prostate Cancer Working Group, the investigators have to wait 12 weeks before the first evaluation. To know soon that the treatment is effective will be decisive for the oncologist, even more in palliative situation where second effects can't be imposed to patients.

In post-docetaxel, the F-choline PET-CT could be used to assess the response of this new therapy. Moreover, the investigators suppose that we can assess an early stage if there is an objective therapeutic response, at 6 weeks of treatment, in order to avoid unnecessarily and expansive treatment.

The aim of this study is to assess if it is possible to determine early (6 weeks of treatment)if a F-choline PET-CT could predict the response to abiraterone acetate or enzalutamide in post-docetaxel.

Being tested
F-Choline-PET
Keywords
castration-resistant prostate cancer, abiraterone acetate, enzalutamide, choline pet

What participants receive

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

  • F-Choline-PETDevice

Study groups in NCT01981707
Study groupRoleWhat they receive
F-Choline PETExperimentalThe F-Choline-PET will be performed before and at 6 weeks of the beginning of treatment by abiraterone acetate or enzalutamide.
Receives: Device: F-Choline-PET

What is being measured

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

  1. Sensitivity and specificity of 6 weeks PET-CT performed on the response after 12 weeks of abiraterone acetate treatment or enzalutamide

    A centralized review will be carried out by 2 independent reviewers. The gold-standard to evaluate tumoral response to abiraterone acetate or enzalutamide will be the pain, the Prostate Specific Antigen rate, and imagery at 3 months according to prostate cancer working group.

    Measured: 12 weeks

Secondary outcomes (4)

  1. Study of global survival and progression-free survival according to the results of baseline F-choline PET .

    Measured: 24 weeks

  2. Study of global survival and progression-free survival at 12 weeks of treatment according to the results of 6 weeks treatment F-choline PET.

    Measured: 12 weeks

  3. Comparison of Area Under the Curve receiver operating characteristic curve for maximum standardized uptake value (SUVmax) different values.

    Measured: 12 and 24 weeks

  4. Study of global survival and progression-free survival at 24 weeks of treatment according to the results of 6 weeks treatment F-choline PET.

    Measured: 24 weeks

Timeline

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

  1. First posted11 Nov 2013 (estimated)
  2. Study startDec 2013
  3. Primary completionDec 2015
  4. Study completionMar 2016

Why it stopped: enrollment default

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 2/3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01981707
Sponsor's protocol ID
2013-003058-25
Acronym
PRECHOL
Status last verified
Apr 2016
First submitted
1 Aug 2013
Last updated
28 Apr 2016
Results posted
No
Data monitoring committee
No

Publications

  • Jemal A, Siegel R, Ward E, Hao Y, Xu J, Murray T, Thun MJ. Cancer statistics, 2008. CA Cancer J Clin. 2008 Mar-Apr;58(2):71-96. doi: 10.3322/CA.2007.0010. Epub 2008 Feb 20.

    PubMed 18287387

  • Townsend DW. Dual-modality imaging: combining anatomy and function. J Nucl Med. 2008 Jun;49(6):938-55. doi: 10.2967/jnumed.108.051276. Epub 2008 May 15.

    PubMed 18483101

  • Jadvar H. Prostate cancer: PET with 18F-FDG, 18F- or 11C-acetate, and 18F- or 11C-choline. J Nucl Med. 2011 Jan;52(1):81-9. doi: 10.2967/jnumed.110.077941. Epub 2010 Dec 13.

    PubMed 21149473

  • de Jong IJ, Pruim J, Elsinga PH, Vaalburg W, Mensink HJ. 11C-choline positron emission tomography for the evaluation after treatment of localized prostate cancer. Eur Urol. 2003 Jul;44(1):32-8; discussion 38-9. doi: 10.1016/s0302-2838(03)00207-0.

    PubMed 12814672

  • Scattoni V, Picchio M, Suardi N, Messa C, Freschi M, Roscigno M, Da Pozzo L, Bocciardi A, Rigatti P, Fazio F. Detection of lymph-node metastases with integrated [11C]choline PET/CT in patients with PSA failure after radical retropubic prostatectomy: results confirmed by open pelvic-retroperitoneal lymphadenectomy. Eur Urol. 2007 Aug;52(2):423-9. doi: 10.1016/j.eururo.2007.03.032. Epub 2007 Mar 20.

    PubMed 17397992

  • Rinnab L, Mottaghy FM, Blumstein NM, Reske SN, Hautmann RE, Hohl K, Moller P, Wiegel T, Kuefer R, Gschwend JE. Evaluation of [11C]-choline positron-emission/computed tomography in patients with increasing prostate-specific antigen levels after primary treatment for prostate cancer. BJU Int. 2007 Oct;100(4):786-93. doi: 10.1111/j.1464-410X.2007.07083.x.

    PubMed 17822459

  • Giovacchini G, Picchio M, Coradeschi E, Bettinardi V, Gianolli L, Scattoni V, Cozzarini C, Di Muzio N, Rigatti P, Fazio F, Messa C. Predictive factors of [(11)C]choline PET/CT in patients with biochemical failure after radical prostatectomy. Eur J Nucl Med Mol Imaging. 2010 Feb;37(2):301-9. doi: 10.1007/s00259-009-1253-3. Epub 2009 Sep 15.

    PubMed 19756592

  • Giovacchini G, Picchio M, Briganti A, Cozzarini C, Scattoni V, Salonia A, Landoni C, Gianolli L, Di Muzio N, Rigatti P, Montorsi F, Messa C. [11C]choline positron emission tomography/computerized tomography to restage prostate cancer cases with biochemical failure after radical prostatectomy and no disease evidence on conventional imaging. J Urol. 2010 Sep;184(3):938-43. doi: 10.1016/j.juro.2010.04.084.

    PubMed 20643445

  • Breeuwsma AJ, Pruim J, van den Bergh AC, Leliveld AM, Nijman RJ, Dierckx RA, de Jong IJ. Detection of local, regional, and distant recurrence in patients with psa relapse after external-beam radiotherapy using (11)C-choline positron emission tomography. Int J Radiat Oncol Biol Phys. 2010 May 1;77(1):160-4. doi: 10.1016/j.ijrobp.2009.04.090. Epub 2009 Sep 23.

    PubMed 19783375

  • Heinisch M, Dirisamer A, Loidl W, Stoiber F, Gruy B, Haim S, Langsteger W. Positron emission tomography/computed tomography with F-18-fluorocholine for restaging of prostate cancer patients: meaningful at PSA < 5 ng/ml? Mol Imaging Biol. 2006 Jan-Feb;8(1):43-8. doi: 10.1007/s11307-005-0023-2.

    PubMed 16315004

  • Bolla M, de Reijke TM, Van Tienhoven G, Van den Bergh AC, Oddens J, Poortmans PM, Gez E, Kil P, Akdas A, Soete G, Kariakine O, van der Steen-Banasik EM, Musat E, Pierart M, Mauer ME, Collette L; EORTC Radiation Oncology Group and Genito-Urinary Tract Cancer Group. Duration of androgen suppression in the treatment of prostate cancer. N Engl J Med. 2009 Jun 11;360(24):2516-27. doi: 10.1056/NEJMoa0810095.

    PubMed 19516032

  • Bolla M, Collette L, Blank L, Warde P, Dubois JB, Mirimanoff RO, Storme G, Bernier J, Kuten A, Sternberg C, Mattelaer J, Lopez Torecilla J, Pfeffer JR, Lino Cutajar C, Zurlo A, Pierart M. Long-term results with immediate androgen suppression and external irradiation in patients with locally advanced prostate cancer (an EORTC study): a phase III randomised trial. Lancet. 2002 Jul 13;360(9327):103-6. doi: 10.1016/s0140-6736(02)09408-4.

    PubMed 12126818

  • Messing EM, Manola J, Yao J, Kiernan M, Crawford D, Wilding G, di'SantAgnese PA, Trump D; Eastern Cooperative Oncology Group study EST 3886. Immediate versus deferred androgen deprivation treatment in patients with node-positive prostate cancer after radical prostatectomy and pelvic lymphadenectomy. Lancet Oncol. 2006 Jun;7(6):472-9. doi: 10.1016/S1470-2045(06)70700-8.

    PubMed 16750497

  • Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, Oudard S, Theodore C, James ND, Turesson I, Rosenthal MA, Eisenberger MA; TAX 327 Investigators. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1502-12. doi: 10.1056/NEJMoa040720.

    PubMed 15470213

  • Petrylak DP, Tangen CM, Hussain MH, Lara PN Jr, Jones JA, Taplin ME, Burch PA, Berry D, Moinpour C, Kohli M, Benson MC, Small EJ, Raghavan D, Crawford ED. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1513-20. doi: 10.1056/NEJMoa041318.

    PubMed 15470214

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing F-Choline-PET in people with Castration-resistant Prostate Cancer, run by University Hospital, Grenoble at 3 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 11 inclusion and 7 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: stopped early, as of the sponsor's last update on 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 was stopped early (reason given: enrollment default). Results are not available in the source record.

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?

Sensitivity and specificity of 6 weeks PET-CT performed on the response after 12 weeks of abiraterone acetate treatment or enzalutamide (time frame: 12 weeks). 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 NCT01981707, which also lists 27 linked publications.

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 28 Apr 2016.

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