Download Questionnaire: Treatment - V4 27/01/12

Centre Code:
Study Number:
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 Questionnaire
Thank you for collaborating in the IMPACT study. Your patient has been diagnosed
with prostate cancer and this questionnaire asks about the types of treatment and
investigations he has received. We would be grateful if you would complete this
questionnaire - most of the questions can be answered by ticking the box that
corresponds to your answer. The information you provide will be used to study
factors that may affect the specific treatment response and the survival rate in men
with a higher genetic risk of prostate cancer.
We will be asking for an annual update and will send you a Treatment Follow-up
form for this purpose. All of this information is strictly confidential and will only be
used for the IMPACT study.
Please answer the questions as accurately and thoroughly as you can. However, if
you are unsure about your answer to any question or feel unable to answer for any
reason, please indicate this on the questionnaire.
If you have any queries please contact:
Ms Elizabeth Bancroft
Research Nurse
Cancer Genetics Unit
Royal Marsden NHS Foundation Trust
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.
Modified from a questionnaire designed by Dr Reza Sharifi, Former Clinical Research Fellow, Royal Marsden Hospital. This
questionnaire has been developed with the help of the EMBRACE, ProtecT and ERSPC studies.
Version 4 Treatment Questionnaire 27/01/12
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SECTION A: DIAGNOSIS
.
A1. PSA at diagnosis
ng/dl
A2. Was the patient symptomatic?
No
Yes
Please, specify symptoms
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
………………………………………………………………………………………………………………
……………………………………………………………………
-
A3. Date of biopsy:
Day
Month
-
Year
Date of diagnosis is classified as date of biopsy
A4. Gleason score:
Major Pattern:
Minor Pattern:
1
1
2
2
3
3
4
4
5
5
Total Score:
A5. Imaging investigations at Diagnosis (please specify all investigations performed and
enclose copies of reports*):
A5.1 CT scan:
No
Yes
Date of scan:
Day
Lymph Node involvement
A5.2 MRI scan:
Yes
Month
No
No
Yes
-
Date of scan:
Day
T stage:
T1
A5.3 Bone scan:
T2a
T2b
T3a
No
Yes
T3b
Suspicious
Month
Year
T4
-
Date of scan:
Day
No metastasis
Year
Month
Year
Positive
A5.4 Other (please specify)……………………………………………………………….
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A6. Staging on imaging (please tick) AJCC TNM 2002 (Please, see Appendix 1)
T:
T1c
T2a
T2b
T2c
T3a
T3b
T4
N:
NX
N0
N1
M:
MX
M1
M0
M1a
M1b
M1c
* Please remove any patient identifiers from imaging reports and replace with IMPACT study number.
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SECTION B: TREATMENT
B1. Please indicate what treatment is being undertaken by your patient following prostate
cancer diagnosis:
Watchful Waiting
Active Surveillance
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)
Other (please, specify)……………………………………
SURGERY
B2. Date of surgery:
Day
Month
Year
Hospital:………………………………………………..
Surgeon:…………………………………………………
B2.1 Radical Prostatectomy procedure:
Radical perineal prostatectomy
Radical retropubic prostatectomy
Laparoscopic radical prostatectomy
Robotic prostatectomy
B2.2: Was lymphadenectomy undertaken?
Yes
No
If yes please state:
- number of nodes resected
- number positive
B2.3: Additional treatment to surgery:
Radiation Therapy after surgery
Neo-adjuvant hormonal treatment
Adjuvant hormonal treatment
Other: (please specify) ………………………
No additional treatment
B.2.4: Complications immediately after surgery
- Immediately after surgery (within 4 weeks):
Myocardial infarction
Deep venous thrombosis (DVT)
Pulmonary embolism
Blood transfusion
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-
At 3 months after surgery
Anastomotic stricture
Inguinal hernia
Incisional hernia
Urinary incontinence
Impotence
Other: please specify..........................................................................
B2.5 Post-surgical pathological staging (TNM 2002): (Please, see Appendix 1)
T1a
T2a
T3a
T4
T1b
N:
NX
N0
M:
MX
M1
M0
T:
T1c
T2b
T3b
T2c
T3c
N1
M1a
M1b
M1c
3
3
4
4
5
5
B2.6 Post-surgical histological Gleason score:
Major Pattern:
Minor Pattern:
1
1
2
2
Total Score:
B2.7 Surgical margins:
Clear
Positive
RADIOTHERAPY
B3. Date of radiotherapy:
-
Start date:
Day
Month
B3.1 Type of Radiotherapy
-
End date
Year
Day
Month
Year
External Beam Radiation (EBR)
Brachytherapy
Brachytherapy with combination of EBR
EBR & Hormone Therapy
Cyberknife
B3.2: Total Dose: …………………………………….
B3.3: Fractionation:…………………………………..
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HORMONOTHERAPY
B4: Neo-Adjuvant Deprivation:
-
Start date:
Month
-
Year
-
Day
Month
Year
B5: Adjuvant androgen deprivation:
-
Start Date:
Day
Day
Yes
No
Duration (Months)………………
Month
-
End date:
No
Duration (Months)………………..
-
Day
End date:
Yes
Year
Month
Year
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OTHER TREATMENTS
B6: Cryoablation:
No
Yes -
-
Date
Day
Month
B7: High-Intensity Focused Ultrasonography (HIFU):
No
Yes
Day
Month
Year
Year
B8: Chemotherapy:
No
Yes
-
Start date:
Day
-
End date:
Courses………………..
Month
Day
Year
Month
Year
Scheme (1st line):
Drug 1…………………………….mg/m2
Drug 2…………………………….mg/m2
Drug 3…………………………….mg/m2
Any toxicity grade 3 or 4?
No
Yes
Please specify......................……….……
B9: Other treatment, please give details:
.………………………………………….…………..…………………………………………
………………………………………………….………………………………………………
………………………….……………….………………..……………………………………
…………………………….……………….……….……….
Please sign and below & enter the date of completion – thank you.
…………………………………………………………….
Signed
Date
Day
Month
Year
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Appendix 1
TNM Clinical Classification of Prostate Cancer
(AJJC, TNM 2002)
T-Primary Tumour
Tx: Primary tumour cannot be assessed
T0: No evidence of primary tumour
T1: Clinically inapparent tumour not palpable or visible by imaging
(Tumour found in one or both lobes by needle biopsy, but not palpable or visible by imaging, is
classified as T1)
T1a: Tumour incidental histological finding in 5% or less of tissue resected
T1b: Tumour incidental histological finding in more than 5% of tissue resected
T1c: Tumour identified by needle biopsy
T2: Tumour confined within prostate
T2a: Tumour involves one half of one lobe or less
T2b: Tumour involves more than half of one lobe, but not both lobes
T2c: Tumour involves both lobes
T3: Tumour extends though the prostatic capsule
(Invasion into de prostatic apex or into (but not beyond) the prostatic capsule is not
classified as T3, but as T2)
T3a: Extracapsular extension (unilateral or bilateral)
T3b: Tumour invades seminal vesicle(s)
T4: Tumour is fixed or invades adjacent structures other than seminal vesicles:
bladder neck, external sphincter, rectum, levator muscles or pelvic wall.
N-Regional Lymph Nodes
Nx: Regional lymph nodes cannot be assessed
N0: No regional lymph node metastasis
N1: Regional lymph node metastasis
M-Distant Metastasis
Mx: Distant metastasis cannot be assessed
M0: No distant metastasis
M1: Distant metastasis
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