| 5. LOCALISED PROSTATE CANCER |
| 5.2. Initial choice of treatment |
| B |
In patients with clinically localised prostate cancer with a life expectancy exceeding 10 years, radical prostatectomy or external beam radiotherapy is recommended. |
| A |
For patients with clinically localised prostate cancer treated with external beam radiotherapy, it must be three-dimensional conformation radiotherapy, as this allows administration of higher radiation doses with greater safety. |
| D |
In patients with clinically localised prostate cancer who receive external beam radiotherapy, it may be associated with brachytherapy to be able to escalate the dose. |
| D |
In patients with clinically localised prostate cancer at low risk (cT1 - cT2a and Gleason < 7 and PSA ≤ 10 ng/ml), low or high dosage brachytherapy as a monotherapy is an alternative treatment intended as a cure for prostate volumes less than 50 cm3. |
| B |
In patients with clinically localised prostate cancer with a life expectancy exceeding 10 years, watching and waiting is a possible alternative. |
| D |
In patients with clinically localised prostate cancer at low risk, Gleason < 3 + 3, < 50% of affected cylinders in the biopsy and PSA density < 15 ng/ml, active monitoring can be offered as an alternative to immediate radical treatment. |
| √ |
Active monitoring for patients will be done in the following way:
- PSA determinations and rectal examinations every three months during the first 2 years, then every six months.
- Prostate biopsy after 1 year, 4 years and 7 years (there must be at least 10 cylinders per biopsy).
|
| √ |
In patients with active monitoring, radical treatment will be considered when any of the following appear: PSA velocity > 1 ng/ml/year, a greater degree or extent of the tumour in repeated biopsies, or evidence of locally advanced disease in a rectal examination. |
| A |
Primary cryotherapy and high intensity focused ultrasound are experimental techniques in patients with clinically localised prostate cancer. |
| A |
RESEARCH RECOMMENDATION: Randomised trials should be started comparing cryotherapy and high intensity focused ultrasound with standard treatments in patients with clinically localised prostate cancer. |
| 5.3. Surgery |
| B |
In clinically localised prostate cancer with an indication of radical prostatectomy, both laparoscopic surgery as well as open can be used.
|
| C |
In patients with clinically localised prostate cancer at low risk (cT1 - cT2a and Gleason < 7 and PSA ≤ 10 ng/ml), lymphadenectomy is not necessary when performing radical prostatectomy.
|
| D |
In patients with clinically localised prostate cancer of intermediate or high risk treated with radical prostatectomy, lymphadenectomy should be performed.
|
| D |
In patients with clinically localised prostate cancer with radical prostatectomy indicated, it is recommended to retain the neurovascular bundles when intraoperatory findings permit.
|
| 5.4. Radiotherapy |
| B |
In patients with clinically localised prostate cancer of low risk (cT1 - cT2a and Gleason < 7 and PSA ≤ 10 ng/ml), the dose of external beam radiotherapy should be 72-74 Gy.
|
| B |
In patients with clinically localised prostate cancer of intermediate risk [cT2b or Gleason = 7 or (PSA > 10 and ≤ 20 ng/ml)], the dose of external beam radiotherapy should be 76-78 Gy.
|
| B |
In patients with clinically localised prostate cancer of high risk (cT2c or PSA > 20 ng/ml or Gleason > 7) or with prostate cancer in the locally advanced clinical stage (cT3), the dose of external beam radiotherapy must be at least 78 Gy.
|
| B |
In patients with localised prostate cancer at low risk, irradiation of the pelvis is not recommended.
|
| C |
In patients with prostate cancer and a risk of lymph node invasion ≥ 15%, irradiation of the prostate and seminal vesicles is recommended.
|
| √ |
RESEARCH RECOMMENDATION: Randomised trials should be started to assess the usefulness of modified fragmentations (hypofragmentation, etc) of radiotherapy for prostate cancer.
|
| 5.5. Hormone therapy |
| A |
In patients with clinically localised prostate cancer of low risk (cT1 - cT2a and Gleason < 7 and PSA ≤ 10 ng/ml) or intermediate risk [cT2b or Gleason = 7 or (PSA> 10 and ≤ 20 ng/ml)], neoadjuvant hormone therapy with radical prostatectomy should be avoided.
|
| B |
In patients with clinically localised prostate cancer of low or intermediate risk, adjuvant hormone therapy with radical prostatectomy should be avoided.
|
| A |
In patients with clinically localised prostate cancer of low risk, neoadjuvant hormone therapy with radiotherapy should be avoided.
|
| B |
In patients with clinically localised prostate cancer of low risk, adjuvant hormone therapy with radiotherapy should be avoided.
|
| √ |
In patients with clinically localised prostate cancer of intermediate risk, neoadjuvant hormone therapy concomitant with radiotherapy is recommended.
|
| √ |
In patients with clinically localised prostate cancer of high risk (cT2c or PSA> 20 ng/ml or Gleason > 7), the criteria used in patients with locally advanced prostate cancer will continue to be used for the use of neoadjuvant and adjuvant hormone therapy with radical prostatectomy or radiation therapy.
|
| 5.6. Monitoring |
| D |
The singular case of a reported combined Gleason score between 2-4 in the specimen from a prostatectomy should be viewed with caution until reviewed by another expert.
|
| D |
Patients with a confirmed combined Gleason score of between 2-4 in the specimen from a prostatectomy do not require monitoring for cancer.
|
| D |
Prostate cancer patients in clinical stages T1a subjected to a radical prostatectomy do not require monitoring for cancer.
|
| D |
Prostate cancer patients in clinical stages T1b-T1c subjected to a radical prostatectomy require monitoring for 10 years.
|
| D |
For the remainder of patients with clinically localised prostate cancer (T2), after treatment with radical prostatectomy, the follow-up period should be 15 years.
|
| D |
The minimum monitoring period for patients with clinically localised prostate cancer after radiotherapy intended to cure it should be 8 years.
|
| D |
For patients with clinically localised prostate cancer treated with radical prostatectomy or radiation therapy, the only monitoring required is PSA control, as long as no PSA relapse is detected.
|
| D |
The recommended frequency for PSA monitoring in patients with clinically localised prostate cancer is as follows: at 3, 6 and 12 months after a treatment intended to cure; then 18, 24, 30 and 36 months, then annually after the third year.
|
| 6. LOCALLY ADVANCED PROSTATE CANCER |
| 6.1. Initial choice of treatment |
| √ |
In patients with prostate cancer at a locally advanced clinical stage and with a life expectancy exceeding 10 years, 3-dimensional conformal external beam radiotherapy or conformal external beam radiotherapy + brachytherapy is recommended.
|
| D |
In patients with prostate cancer at a locally advanced stage requiring radiotherapy treatment, 3-dimensional conformal radiotherapy is an alternative in centres where intensity modulated radiotherapy (IMRT) is not available.
|
| √ |
In patients with prostate cancer at a locally advanced stage with a life expectancy exceeding 10 years and a low risk of it affecting the lymph node (cT3a + Gleason < 8 + PSA < 20 ng/ml), treatment with radical prostatectomy could be considered.
|
| √ |
In patients with prostate cancer at a locally advanced stage with a life expectancy less than 10 years, watching and waiting or hormone therapy may be therapeutic alternatives.
|
| A |
Neoadjuvant hormonal therapy should be administered to patients with prostate cancer at a locally advanced clinical stage where radiotherapy treatment is indicated.
|
| C |
The normal duration of neoadjuvant hormonal treatment with radiotherapy in patients with prostate cancer at a locally advanced stage is 3 months.
|
| A |
Hormonal adjuvant radiotherapy is recommended in patients with prostate cancer at a locally advanced clinical stage.
|
| D |
The normal duration of neoadjuvant hormonal treatment after radiotherapy in patients with prostate cancer at a locally advanced stage is 2-3 years.
|
| B |
Neoadjuvant hormone therapy is not recommended in patients with prostate cancer at a locally advanced clinical stage who will receive radical prostatectomy.
|
| B |
Adjuvant hormone treatment with prostatectomy is not recommended in patients with prostate cancer at a locally advanced clinical stage, unless spreading to the lymph node is demonstrated.
|
| A |
In patients with prostate cancer at a locally advanced clinical stage, primary cryotherapy and high intensity focused ultrasound are experimental techniques.
|
| A |
RESEARCH RECOMMENDATION: Randomised trials should be started comparing cryotherapy and high intensity focused ultrasound with standard treatments in patients with prostate cancer at a locally advanced clinical stage.
|
| √ |
RESEARCH RECOMMENDATION: Randomised trials should be started to assess the usefulness of docetaxel administered as a concomitant or adjuvant to radiotherapy after local treatment.
|
| 6.2. Adjuvant radiotherapyª |
| √ |
In patients with locally advanced prostate cancer and/or microscopically positive surgical margins after radical prostatectomy, systematic use of adjuvant radiotherapy is not recommended.
|
| 6.3. Lymphadenectomy |
| A |
Lymphadenectomy would be indicated in patients with prostate cancer at a locally advanced clinical stage who underwent radical prostatectomy, as a staging and post-evaluation of adjuvant treatment
|
| √ |
In patients with prostate cancer at a locally advanced clinical stage with radical surgery indicated, carrying out an extended lymphadenectomy may be of therapeutic interest.
|
| 6.4. Neo or adjuvant hormone therapy |
| A |
For patients with prostate cancer at a locally advanced clinical stage where hormone therapy is suggested as an addition to surgery or radiotherapy, the appropriate hormone treatment (monotherapy with antiandrogens, LHRH agonist monotherapy or complete androgen block) cannot be determined.
|
| √ |
RESEARCH RECOMMENDATION: Randomised trials should be started to determine the appropriate hormone treatment (monotherapy with antiandrogens, LHRH agonist monotherapy or complete androgen block) in patients with prostate cancer at a locally advanced clinical stage.
|
| 7. PROSTATE CANCER IN PSA RELAPSE |
| 7.1. Definition of PSA relapse |
| D |
In prostatectomised patients, biochemical recurrence of the disease will be considered when the serum levels of PSA exceed 0.4 ng/ml. |
| D |
In those patients who have received radiotherapy or brachytherapy as curative intent, biochemical recurrence of the disease will be considered when the serum levels of PSA increase by 2 ng/ml above the PSA nadir. |
| 7.2. Salvage treatment after surgery |
| D |
In patients with PSA relapse of the disease after radical prostatectomy, with no distant metastasis or other risk factors, early salvage radiotherapy should be offered before the PSA exceeds 2.5 ng/ml.
|
| D |
Salvage hormonal therapy may be indicated for those men with PSA relapse after radical prostatectomy who also exhibit symptomatic local progression, existence of distant metastases or doubling of PSA levels in less than 10 months.
|
| 7.3. Salvage treatment after radiotherapy |
| D |
Salvage radical prostatectomy can be offered after radiotherapy treatment in patients with local recurrence showing few associated comorbidities, a life expectancy of at least 10 years, with cT1-T2, Gleason < 7 and a pre-surgical PSA < 10 ng/ml.
|
| D |
Hormone therapy should be considered as a salvage therapeutic option for patients treated by radiotherapy and local recurrence of the disease who cannot be offered salvage radical prostatectomy.
|
| D |
The adoption of other salvage therapeutic alternatives (cryotherapy or high intensity focused ultrasound) should be considered within the field of experimentation.
|
| D |
RESEARCH RECOMMENDATION: Clinical trials should be launched to evaluate local salvage therapies in terms of survival and quality of life in men with biochemical recurrence after radiotherapy or brachytherapy.
|
| 7.4. Hormone therapy |
| D |
In patients with PSA relapse after radical prostatectomy for whom hormone treatment has been decided, if they have Gleason > 7, PSA ≤ 5 ng/ml and a PSA duplication time of less than 1 year, it is recommended that the hormone treatment be applied early.
|
| √ |
In patients with PSA relapse after radical radiotherapy or brachytherapy in which hormone treatment is indicated, the decision on the timing of its application should be on an individual basis.
|
| 7.5. Intermittent vs continuous hormone therapy |
| A |
In patients in PSA relapse after radical treatment for whom hormone therapy has been decided, it cannot be determined whether continuous or intermittent application is better.
|
| 8. DISSEMINATED PROSTATE CANCER |
| 8.1. Hormone therapy |
| A |
In patients with disseminated prostate cancer for whom hormone therapy has been indicated, castration (surgical or chemical) is recommended as a first-line treatment. |
| D |
In patients with symptomatic disseminated prostate cancer, hormone treatment is recommended. |
| B |
In patients with asymptomatic disseminated prostate cancer, hormone therapy which is immediate or deferred (until the onset of symptoms) may be offered. |
| √ |
In patients with disseminated prostate cancer and low tumour load, intermittent androgen suppression may be assessed as an alternative to continuous androgen suppression if there is a good response to the initial hormone treatment. |
| √ |
To be able to indicate intermittent hormone therapy, the patient must have received androgen deprivation for at least 7 months and have reached a PSA < 4 ng/ml (stable or in decline during the sixth and seventh month) or a 90% reduction in the levels previous to treatment. Monitoring will be performed every 6 months. Patients who interrupt androgen deprivation will receive another cycle of androgen suppression when requested, when the PSA increases or when showing clinical signs of disease progression. If, after the new cycle of androgen deprivation, the PSA returns to normal, the hormone therapy can be interrupted again. |
| √ |
In patients with androgen-independent disseminated prostate cancer (those for whom androgen suppression and complete androgen blockade have failed), second-line hormone therapy can be offered before starting chemotherapy treatment. |
| √ |
RESEARCH RECOMMENDATION: Patients with androgen-independent disseminated prostate cancer (those for whom androgen suppression and complete androgen blockade have failed) should be offered inclusion in clinical trials to evaluate the efficacy and safety of second-line hormone therapy, comparing it with chemotherapy that has proven effective.
|
| 8.2. Chemotherapy |
| B |
In patients with androgen-independent prostate cancer (AIPC) and metastatic prostate cancer, when chemotherapy is suggested, docetaxel (75 mg/m2 every 3 weeks) with corticoid is recommended. |
| √ |
In patients with AIPC and metastatic prostate cancer, it is not recommended to systematically combine docetaxel/oestramustine. |
| √ |
In patients with biochemical relapse, androgen-independence, asymptomatic and without documented metastatic disease, they can be offered an early start for chemotherapy, especially within the framework of randomised clinical trials. |
| √ |
RESEARCH RECOMMENDATION: Patients with biochemical relapse, androgen-independence, asymptomatic and without documented metastatic disease should be offered inclusion in clinical trials that compare early and delayed start chemotherapy. |
| √ |
In patients with androgen-independence, LHRH agonists may continue to be applied. |
| √ |
RESEARCH RECOMMENDATION: Patients with androgen-independent disseminated prostate cancer for whom chemotherapy treatment has been decided, should be offered inclusion in clinical trials to compare the safety and efficacy of exclusive chemotherapy to that for chemotherapy associated with LHRH agonists.
|
| 8.3. Bisphosphonates and radiopharmaceuticals |
| B |
The systematic use of bisphosphonates (zoledronic acid) as a preventive treatment in bone complications is not recommended. Zoledronic acid (4 mg every 3 weeks) can be offered in selected hormone-independent patients with demonstrated metastasis. |
| A |
In men with androgen-independent prostate cancer (AIPC), treatment with Sr-89 or Sm-153 can be proposed when there is bone pain that requires third step analgesics which are not adequately controlled. To administer them, a correct haematological formula (> 3,500 leukocytes and > 150,000 platelets) and a bone scan showing bone metastasis are necessary. |
