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Study Number: Centre Code: Date of Birth: Day Month Initials: Year The IMPACT Study - Identification of Men with a genetic predisposition to ProstAte Cancer: Targeted screening in men at higher genetic risk and controls TREATMENT FOLLOW-UP FORM Thank you for collaborating in the IMPACT study. Your patient has been diagnosed with prostate cancer and last year you sent information about the types of treatment and investigations he has received. Please could you complete this short follow-up form to update us about any new treatments or investigations he has received. All of this information is strictly confidential and will only be used for the IMPACT study. If you have any queries please contact: Ms Elizabeth Bancroft Research Nurse Cancer Genetics Unit Royal Marsden NHS trust Foundation Downs Road, Sutton Surrey SM2 5PT UK Tel: +44 (0)207 808 2136 Fax: +44 (0)208 770 1489 Email: [email protected] Thank you for completing this questionnaire Version 3 27.01.12 Treatment Follow up Questionnaire 1 Date of Completed Treatment Questionnaire (Data Centre to complete): Day Month Year - 1. Date of last visit: Day Month Year 2. Please record all PSA values since last visit: Date PSA value 3.1 Since the last visit, has the patient had disease recurrence? (If NO, please go to 4.) No Yes Biochemical Recurrence (PSA only) Local recurrence Lymphatic node relapse Para aortic nodes Pelvic nodes Metastatic disease: Other Bone Other 3.2. Has the patient received any treatment after the recurrence? No Yes Radical Prostatectomy only Radical Prostatectomy and adjuvant radiation therapy Prostatectomy and radiotherapy and hormones Radiotherapy alone Radiotherapy and adjuvant androgen ablation Brachytherapy Cryoablation Therapy High-Intensity Focused Ultrasonography (HIFU) Hormonotherapy alone Chemotherapy alone Version 3 27.01.12 Treatment Follow up Questionnaire 2 3.3 Hormone Treatment: If since the last visit the patient has received HT, tick as appropriate: LHRH alone - Start Date: - Duration (months)…………………………….. Response?: Complete Response Partial Response Stabilization Progression Stabilization Progression Stabilization Progression Antiandrogens alone Start Date - - Duration (months)…………………………….. Response?: Complete Response Partial Response LHRH+Antiandrogens Start Date - - Duration (months)…………………………….. Response?: Complete Response Partial Response If since the last visit, the patient has received more than one line of HT, could you specify the lines and reason for change it, please? ……………………………………………………………………………………......................... ...............................................................................................…………………………………… ……………………………………………………………………………………………………. 3.4 Chemotherapy If since the last visit, the patient has received chemotherapy, please complete the following items: 1st line: Start Date - - End Date - - Number of Cycles…… Drug 1………………………….….mg/m2 Drug 2……………………………..mg/m2 Drug 3……………………………..mg/m2 Version 3 27.01.12 Treatment Follow up Questionnaire 3 Any grade 3 or 4 toxicity? No Yes, please specify……………………………. Response: Complete Response Partial Response Stabilization Progression Comments………………………….………… 2nd line: Start Date - - End Date - - Number of Cycles…… Drug 1………………………….….mg/m2 Drug 2……………………………..mg/m2 Drug 3……………………………..mg/m2 Any grade 3 or 4 toxicity? No Yes, please specify……………………………. Response: Complete Response Partial Response Stabilization Progression Comments………………………….………… 3nd line: Start Date - - End Date - - Number of Cycles…… Drug 1………………………….….mg/m2 Drug 2……………………………..mg/m2 Drug 3……………………………..mg/m2 Any grade 3 or 4 toxicity? No Yes, please specify……………………………. Response: Complete Response Partial Response Stabilization Progression Comments………………………….………… Version 3 27.01.12 Treatment Follow up Questionnaire 4 4.1. Please list of any of the following that have occurred in the last year: Type of Imaging CT Scan Date of report Result (please enclose copies of reports*) 1 2 MRI 1 2 Transrectal Ultrasound (TRUS) 1 2 Bone Scan 1 2 IVP 1 (Intravenous Pyleogram) 2 Other 1 2 * Please remove any patient identifiers from imaging reports and replace with IMPACT study number. 4.2. If any of the pervious exams have been done for any other reason different from follow up (i.e. pain, bleeding, etc…), please specify: ………………………………………………………………………………………………………………………. ………………………………………………………………………………………………………………………. ………………………………………………………………………………………………………………………. ………………………………………………………………………………………………………………………. ……………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………… Version 3 27.01.12 Treatment Follow up Questionnaire 5 5. Please ask the patient to score the following urinary symptoms: Over the past month, how often have you… Not at all Less than 1 time in 5 1. … had a sensation of not emptying your bladder completely after you finished urinating? ? 2. …had to urinate again less than two hours after you finished urinating? 3. …stopped and started again several times while urinated? 4. …found it difficult to postpone urination? 5. …had a weak urinary stream? 6. …had to push or strain to begin urination 0 7. Over the last month how many times did you typically get up to urinate from the time you went to bed at night until you got up in the morning? About half the time 3 More than half the time 4 Almost always 1 Less than half the time 2 0 1 2 3 4 5 0 1 2 3 4 5 0 1 2 3 4 5 0 1 2 3 4 5 0 1 2 3 4 5 None Once Twice 3 times 4 times 0 1 2 3 4 5 times or more 5 Score 5 Total Score ________ 0 – no symptoms 1-7 indicate mild symptoms of an enlarged prostate 8-19 indicates moderate symptoms of an enlarged prostate 20-35 indicates severe symptoms Version 3 27.01.12 Treatment Follow up Questionnaire 6 6. Please ask the patient to score the following questions about sexual function: 1. How do you rate your confidence that you could get and keep an erection? 2. When you had erections with sexual stimulation, how often were you erections hard enough for penetration (entering your partner)? 3. During sexual intercourse, how often were you able to maintain your erection after you had penetrated (entered) your partner 4. During sexual intercourse, how difficult was it to maintain your erection to completion of intercourse? 5. When you attempted sexual intercourse, how often was it satisfactory for you? No sexual activity Very low 1 Almost never or never 0 No sexual activity 1 Almost never or never 0 Did not attempt intercourse 0 No sexual activity 1 Extreme ly difficult 1 Almost never or never 0 1 Low 2 A few times (much less than half the time) 2 A few times (much less than half the time) 2 Very difficult 2 A few times (much less than half the time) 2 Medium High 3 4 Most times (much more than half the time) 4 Most times (much more than half the time) 4 Slightly difficult Very high 5 Almost always or always 5 Almost always or always 5 Not difficult 4 Most times (much more than half the time) 4 5 Almost always or always 5 Sometimes (about half the time) 3 Sometimes (about half the time) 3 Difficult 3 Sometimes (about half the time) 3 SCORE Total Score ________ (If the score is 21 or less the patient may be showing signs of erectile dysfunction) Version 3 27.01.12 Treatment Follow up Questionnaire 7 7. Please complete the below: Assessment for Late Side-Effects after Radiotherapy (Score symptoms over the last 4 weeks) Please circle appropriate response URINARY SYMPTOMS (excluding urinary tract infections) Average daytime frequency 1. >2 hourly 2. 2 hourly 3. 1-2 hourly (no treatment) 4. 1-2 hourly (simple out-patient management) 5. <1 hourly 9. Unknown Nocturia 1. 0-1 times 2. 2-3 times 3. 4-5 times 4. 6-8 times 5. >8 times 9. Unknown Incontinence 1. None 2. Occasional incontinence 3. Frequent incontinence requiring use of pads 4. Unknown BOWEL SYMPTOMS Frequency 1. 1-2 times 2. 3-4 times (no medical treatment) 3. 3-4 times (simple out-patient management) 4. ≥ 5 times +/- treatment 9. Unknown Rectal Bleeding 1. None 2. Occasional (no treatment) 3. Moderate (simple outpatient management) 4. Severe (blood transfusion, surgery) 9. Unknown Erectile Potency 1. Normal Erection 2. Decreased 3. Absent 9. Unknown RTOG Gradings for late side effects after radiotherapy (Score symptoms over the last 4 weeks) Please Grade 0-5 Diarrhoea ______ Proctitis ______ Cystitis ______ Grading System Grade 0 – no symptoms Grade 1 – minor symptoms requiring no treatment Grade 2 – symptoms responding to simple outpatient management, lifestyle (performance status not affected) Grade 3 – distressing symptoms altering patient’s lifestyle performance status). Hospitalisation for diagnosis or minor surgical intervention (such as urethral dilation) may be required Grade 4 – major surgical intervention (such as laparotomy, colostomy, cystectomy) or prolonged hospitalisation required Grade 5 – fatal complications Haematuria ______ Diarrhoea is defined as a clinical syndrome characterised by frequent loose bowel movements without associated rectal irriation (tenesmus) Proctitis is defined as a clinical syndrome characterised by rectal irritation or urgency (tenesmus), presence of musus or blood in the stool and, in some patients, with frequent, sometimes looses, bowel movements. Cystitis is difined as a syndrome characterised by irritative bladder symptoms such as frequency and dysuria. Haematuria may or may not be part of the clinical picture of cystitis. Please sign and below & enter the date of completion – thank you. Signed ……………………………………………………………. Date Day Month Year Version 3 27.01.12 Treatment Follow up Questionnaire 8