Condition category
Cancer
Date applied
26/07/2011
Date assigned
26/07/2011
Last edited
21/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Ms Judith Dixon

ORCID ID

Contact details

1053 Great Western Road
Glasgow
G12 0YN
United Kingdom
+44 141 301 7945
Judith.Dixon@glasgow.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

10051

Study information

Scientific title

randomised controlled trial of deferred androgen deprivation therapy +/- upfront CRyOtherapy in men with localised radiation recurrent Prostate cancer (RRPC) to evaluate efficacy and tolerability

Acronym

CROP

Study hypothesis

This is an open, multi-centre, phase III randomised controlled trial (RCT) to investigate the role of salvage prostate cryotherapy in patients with localised recurrent prostate cancer following radiotherapy. Recruited patients will be randomised into one of two arms: an intervention arm with salvage prostate cryotherapy followed by non-surgical management at failure (deferred ADT) or a control arm with non-surgical management (deferred ADT) only.

The proposed RCT will evaluate the outcome among patients managed with deferred androgen ablation with or without upfront salvage prostate cryotherapy for their RRPC. The endpoint will be distant metastasis free survival (DMFS). The toxicity profile, assessment of patient quality of life and health economic analysis also form integral parts of the study.

Primary Objective
To determine the efficacy of salvage prostate cryotherapy in RRPC in combination with deferred androgen deprived therapy (ADT) in patients with radiation recurrent prostate cancer

1. To evaluate the safety and tolerability of prostate cryotherapy in RRPC
2. To determine the side effect profile of salvage cryotherapy and its impact on the quality of life for patients
3. To determine within this study the optimal health economic model for cost-effectiveness analysis to assess cryotherapy against current management plans
4. To determine the likely costs to the NHS if prostate cryotherapy is adopted widely for RRPC

Ethics approval

West of Scotland REC1 approved on 07 April 2011, ref: 11/S0703/2

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient information sheet can be found at http://www.prostatecryotherapy.scot.nhs.uk/index.php/new-developments

Condition

Topic: National Cancer Research Network; Subtopic: Prostate Cancer; Disease: Prostate

Intervention

Patients will be randomised equally across the two study treatment arms. 270 patients will receive upfront salvage prostate cryotherapy followed by deferred androgen deprivation therapy. 270 patients will receive deferred androgen deprivation therapy alone

Deferred ADT, The option of intermittent or continuous ADT is permitted at the discretion of the Investigator, but the intention is to be declared at randomisation.

Salvage prostate cryotherapy, Salvage prostate cryotherapy will be given upfront to those patients randomised to Arm B (cryotherapy + deferred ADT);

Follow Up Length: 90 month(s); Study Entry : Single Randomisation only

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

Distant Metastasis Free Survival (DMFS); Timepoint(s): DMFS assessed annually by MRI and bone scan

Secondary outcome measures

1. Acute and late side effects of cryotherapy; Timepoint(s): Meausred using NCI CTCAE; Efficacy; Timepoint(s): PSA 3 monthly in year 1, annually thereafter
2. Prostate biopsy at 6 months post cryotherapy; Functional Status; Timepoint(s): validated questionnaires at 3, 6, 12 months and annually thereafter

Overall trial start date

01/06/2011

Overall trial end date

01/06/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically confirmed relapsed prostate cancer following previous treatment with radiation therapy (either external beam or brachytherapy) for either organ confined or non-metastatic locally advanced prostate cancer, namely T1-3aN0M0 disease
2. Life expectancy of at least 5 years
3. Clinical/radiological T1c-T3a
4. Prostrate specific antigen (PSA) level = 20 ng/ml
5.. Aged 18 years or over
6. Eastern Cooperative Oncology Group Performance Status Scale (ECOG PS) = 0 or 1 or 2
7. Ability to provide informed consent
8. Adequate haematological function as defined by haemoglobin (Hb) = 100g/L; platelets = 100 x 109/L; neutrophils =1.5 x109/L
9. Adequate biochemical function as defined by bilirubin = 1.5 upper limit of normal (ULN); alanine aminotransferase (ALT), aspartate aminotransferase (AST) = 2.5 x ULN, alkaline phosphatase = 2.5 x ULN and adequate renal function defined as either serum creatinine = 1.5 x ULN OR calculated/measured creatinine clearance = 60mls/min (as defined by Cockcroft and Gault formula); Target Gender: Male ; Lower Age Limit 18 years

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

Planned Sample Size: 540; UK Sample Size: 540

Participant exclusion criteria

1. Lymph node >10mm short axis on magnetic resonance imaging (MRI) abdomen and pelvis
2. Previous transurethral resection of prostate gland with evidence of a significant defect (>10mm in width) on transrectal ultrasound scan
3. Significant lower urinary tract symptoms, including bladder outflow obstructive symptoms
4. History of abdomino-perineal resection of rectum.
5. Known coagulation disorder
6. Complex perianal fistula
7. Previous combined external beam radiotherapy and brachytherapy to the prostate
8. Significant symptoms/toxicity related to the rectum following radiotherapy National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grade 3 or above
9. Failed androgen deprivation therapy as second line therapy for radiation recurrent prostate cancer
10. Prior cryotherapy to the prostate
11. Any evidence of severe or uncontrolled systemic conditions (e.g. severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease]) or current unstable or uncompensated respiratory or cardiac conditions which make it undesirable for the patient to participate in the study or which could jeopardise compliance with the protocol
12. Other prior malignancy with estimated =30% chance of relapse within 5 years

Recruitment start date

01/06/2011

Recruitment end date

01/06/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

1053 Great Western Road
Glasgow
G12 0YN
United Kingdom

Sponsor information

Organisation

NHS Greater Glasgow & Clyde (UK)

Sponsor details

c/o Nathaniel Brittain
Tennent Building
38 Church Street
Glasgow
G11 6NT
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Charity

Funder name

Clinical Trials Awards and Advisory Committee (CTAAC) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26482768

Publication citations

Additional files

Editorial Notes

21/10/2015: Publication reference added.