Symptoms and General Pathology

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Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Prostatic Neoplasms

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Urogenital Neoplasms

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Genital Diseases, Male

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Choline

Comparing the detection rate of metastases of whole body MRI compared to current standard of care tests - Choline PET and Bone scan.

Transperineal MRI-targeted biopsies and whole-gland transperineal prostate mapping biopsies

Focal salvage HIFU and cryotherapy of recurrent prostate cancer tumors only

Full parametric MRI using T1W, T2W, Diffusion-weighted and dynamic-contrast-enhanced images at 3Tesla

Whole Body MRI

Cryotherapy and HIFU will be used to targeted the areas of tumor only with a margin of normal tissue.

Focal Salvage Therapy

Image registration will be used to target biopsies followed by full mapping biopsies of the prostate. All biopsies will be carried out transperineally

MRI Targeted biopsies

Abi A Kanthabalan, MBChB

Hashim U Ahmed, FRCS, PhD

Richard Hindley, FRCS, MD

Abi Kanthabalan

Manit Arya, FRCS

Mark Emberton, FRCS, MD

Shonit Punwani, FRCR

Radiotherapy is the commonest form of prostate cancer treatment in the UK. In one in four men, radiotherapy will fail to control the cancer. These men are offered hormonal treatment which has significant side effects. Few men are offered a further treatment such as surgery, HIFU or cryotherapy. Only half of these men are cancer free at 5 years. The investigators believe this is due to poor imaging tests such as CT and Bone scan that cannot accurately detect whether cancer has come back inside or outside of the prostate or both. Also radiotherapy damages tissue surrounding the prostate which affects tissue healing for example after surgery. Treating just the cancer in the prostate only (focal treatment) rather than the whole prostate may limit this damage and cause fewer side-effects. The investigators want to see if new imaging tests can better identify cancer that has spread outside of the prostate and areas of cancer inside the prostate. Our new tests are whole-body MRI (for distant disease) and MRI guided biopsies (MRI-TB) (for local disease). First, the investigators will compare the results of whole-body MRI to existing imaging tests (bone-scan, and choline PET/CT) that try to find distant spread. Second, the investigators will compare the results of MRI-TB to a very detailed and accurate biopsy of the prostate called template prostate mapping which will show us where and how aggressive the cancer is. Third, if the cancer is confined to the prostate, the investigators will treat men using focal salvage therapies HIFU and cryotherapy. The investigators believe that these new imaging tests could better identify those who will benefit from early hormone treatment and those who will benefit from local salvage treatment. Our study may help justify carrying out a larger trial looking at how good the treatment is in controlling cancer in the medium and long-term.

FOcal RECurrent Assessment and Salvage Treatment

An Evaluation of a Novel Imaging Based Complex Diagnostic and Therapeutic Pathway Intervention for Men Who Fail Radiotherapy for Prostate Cancer.

Treatment

Continence Presence of urinary incontinence (any pad usage) as determined by the UCLA-EPIC urinary continence questionnaire, at 12 months, in those men with no urinary incontinence at baseline

Whole body MRI lesions suspicious of lymph node, visceral or bone metastases compared to standard care tests

- Sensitivity, specificity, negative and positive predictive values of whole-body MRI to detect distant disease compared to standard care tests (isotope bone-scan, PET/CT-scan, with skeletal survey where appropriate) and/or pelvic lymphadenectomy and/or biopsy of distant areas in indeterminate cases

Imaging of Local Disease

Transperineal multi-parametric MRI targeted biopsies compared to Template Prostate Mapping biopsies in the detection of UCL definition 2 clinically significant prostate cancer (Gleason \>/=3+4 AND/OR Maximum Cancer Core Length \>/=4mm in any one biopsy)

University College London Hospitals

MRC Clinician Scientist and Clinical Lecturer in Urology

Neoplasm Metastasis

Fluorides

Hypolipidemic Agents

Antimetabolites

Every eligible patient will be scanned with Choline-PET at the time of diagnosis of prostate cancer. MRI will also be obtained as it is the current standard of care. CT scan will be obtained as part of the same procedure while procuring the Choline-PET scan with PET-CT dual imaging hardware.

Carbon-11 or Fluorine-18 PET-CT will be acquired with a scanner with integrated PET and CT scanning ability at the time of diagnosis. It must be however noted that Choline-PET will not be considered as an alternative to magnetic resonance imaging (MRI). In fact, all patients will undergo MRI too.

Choline-PET

Sridhar P Susheela, MD, DNB

Swaroop Revannasiddaiah, MD

Sridhar P Susheela, MD

Ajaikumar Basavalingaiah, MD

Kumar G Kallur, MD

Sandeep Muzumder, MD

Govindarajan Mallarajapatna, MD

Raghunath S Krishnappa, MS, DNB

Nodal involvement among patients with prostate cancer is known to be a poor prognostic factor. Traditionally, the presence or absence of nodal disease in patients with prostate cancer is ascertained with the use of anatomical imaging methods such as computed tomography (CT) and magnetic resonance imaging (MRI).

However, the sensitivities of CT and MRI for the detection of pelvic nodal disease is rather low, with reports placing the value to lie between 50-80%.

Positron emission tomography (PET) with the use of carbon-11 or fluorine-18 tagged choline (Choline-PET) is an approach which is known to deliver a high sensitivity for the imaging of prostate cancer disease burden in the primary, nodal and the metastatic areas.

The investigators in this prospective trial intend to utilize Choline-PET among all newly diagnosed patients of prostate cancer who are presumed to be non-N1 (absence of nodal disease on conventional imaging) and non-M1 (absence of metastatic disease on conventional imaging).

Choline-PET for Evaluating the Incidence of Nodal Metastases Among Newly Diagnosed Patients of Prostate Cancer

Evaluation of the Incidence of Choline-PET Detected Nodal Metastases Among Newly Diagnosed Prostate Cancer Patients With Presumed Absence of Nodal and Distant Metastases.

Evidence of extra-pelvic non-nodal metastases detected by Choline-PET scan will be recorded.

At the time of diagnosis of prostate cancer, the investigators intend to utilize Choline-PET scan to gain evidence of nodal metastatic disease with a motive to assess for a potentially higher sensitivity than with the use of conventional imaging methods such as CT or MRI.

For each enrolled patient, the information regarding nodal metastatic disease gained from Choline-PET scan will be compared with CT scan data.

For each enrolled patient, the information regarding nodal metastatic disease gained from Choline-PET scan will be compared with MRI scan data.

Bangalore Institute of Oncology

Principal Investigator

Prostatic Neoplasms, Castration-Resistant

Antineoplastic Agents

Abiraterone Acetate

The F-Choline-PET will be performed before and at 6 weeks of the beginning of treatment by abiraterone acetate or enzalutamide.

F-Choline-PET

Jean-Philippe Vuillez, MD PHD

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.

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

F-choline PET in Early Response Assessment for Castration Resistant Prostatic Cancer Treated by Abiraterone Acetate 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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
FOcal RECurrent Assessment and Salvage Treatment	NCT01883128	Progression of ...	Whole Body MRI Focal Salvage T... MRI Targeted bi...	18 Years -	University College London Hospitals
Choline-PET for Evaluating the Incidence of Nodal Metastases Among Newly Diagnosed Patients of Prostate Cancer	NCT01769950	Prostate Cancer	Choline-PET	-	Bangalore Institute of Oncology
F-choline PET in Early Response Assessment for Castration Resistant Prostatic Cancer	NCT01981707	Castration-resi...	F-Choline-PET	18 Years -	University Hospital, Grenoble
Choline-PET for Evaluating the Incidence of Nodal Metastases Among Newly Diagnosed Patients of Prostate Cancer	NCT01769950	Prostate Cancer	Choline-PET	-	Bangalore Institute of Oncology

Spots Global Cancer Trial Database for choline pet

Every month we try and update this database with for choline pet cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for choline pet

Every month we try and update this database with for choline pet cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for choline pet cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.