To evaluate efficacy and tolerability of deferred androgen deprivation therapy +/- upfront CRyOtherapy in men with localised radiation recurrent Prostate cancer (RRPC)
| ISRCTN | ISRCTN72677390 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72677390 |
| Secondary identifying numbers | 10051 |
- Submission date
- 26/07/2011
- Registration date
- 26/07/2011
- Last edited
- 26/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Stopped
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Contact information
Ms Judith Dixon
Scientific
Scientific
1053 Great Western Road
Glasgow
G12 0YN
United Kingdom
| Phone | +44 141 301 7945 |
|---|---|
| Judith.Dixon@glasgow.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Patient information sheet can be found at http://www.prostatecryotherapy.scot.nhs.uk/index.php/new-developments |
| 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 |
| Study 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(s) | West of Scotland REC1 approved on 07 April 2011, ref: 11/S0703/2 |
| Condition | Prostate cancer |
| 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 |
| Primary outcome measure | 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 study start date | 01/06/2011 |
| Overall study end date | 01/06/2020 |
| Reason abandoned (if study stopped) | Lack of efficacy |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | Planned Sample Size: 540; UK Sample Size: 540 |
| 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 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
- Scotland
- United Kingdom
Study participating centre
1053 Great Western Road
Glasgow
G12 0YN
United Kingdom
G12 0YN
United Kingdom
Sponsor information
NHS Greater Glasgow & Clyde (UK)
Government
Government
c/o Nathaniel Brittain
Tennent Building
38 Church Street
Glasgow
G11 6NT
United Kingdom
"ROR" |
https://ror.org/05kdz4d87 |
|---|
Funders
Funder type
Charity
Clinical Trials Awards and Advisory Committee (CTAAC) (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 19/10/2015 | Yes | No | |
| Plain English results | 26/10/2022 | No | Yes |
Editorial Notes
25/10/2022: Cancer Research UK plain English results link added.
12/05/2020: The trial status has been updated to "Stopped".
03/04/2019: The condition has been changed from "Topic: National Cancer Research Network; Subtopic: Prostate Cancer; Disease: Prostate" to "Prostate cancer" following a request from the NIHR.
21/10/2015: Publication reference added.
