Surgery Versus Radiotherapy for Locally Advanced Prostate Cancer (SPCG-15)
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| ClinicalTrials.gov Identifier: NCT02102477 |
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Recruitment Status :
Recruiting
First Posted : April 3, 2014
Last Update Posted : May 3, 2021
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This prospective, open randomized phase III surgical trial seeks to study whether radical prostatectomy (with or without the combination of external radiation) improves prostate-cancer specific survival in comparison with primary radiation treatment and hormonal treatment among patients diagnosed with locally advanced (T3) prostate cancer. Untreated or conservatively treated locally advanced prostate cancer is associated with high mortality. Modern curative treatment for advanced solid malign tumors include surgery and/or radiation plus attempted chemotherapy if available to achieve both local control and elimination of potential micro metastases. Whereas there is evidence that surgery can cure localized prostate cancer, there are no clinical trials of multi-modal treatment of locally advanced prostate cancer that includes surgical removal of the prostate.
One potential advantage of adding prostatectomy to the treatment of LAPC is that removing the prostate enables a full pathological assessment of the tumor characteristics and thus a better estimation of the risk of recurrence. Surgical treatment could thus reduce the numbers needed to treat with chemotherapy and radiation, and thus improve quality of life after treatment. In addition, evidence indicate that residual cancer in the prostate occurs in 25% after radiation treatment (56) and surgical removal of the prostate may improve survival beyond what can be achieved by radiation and ADT. On the other hand, patients treated with surgery, radiation and hormones will experience side effects of all three treatment modalities and might fare better if radiotherapy plus hormones can provide oncological control without prior surgery.
A randomized clinical trial comparing two multimodal treatment regimens of which one includes a radical prostatectomy is therefore warranted.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prostatic Neoplasms | Procedure: Prostatectomy/Surgery Other: Radiotherapy with adjuvant androgen deprivation therapy | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1200 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Primary Radical Prostatectomy Versus Primary Radiotherapy for Locally Advanced Prostate Cancer: an Open Randomized Clinical Trial |
| Actual Study Start Date : | October 2014 |
| Estimated Primary Completion Date : | December 2021 |
| Estimated Study Completion Date : | December 2031 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Prostatectomy/Surgery
Patients with locally advanced prostate adenocarcinoma recieves Prostatectomy/Surgery with or without adjuvant or salvage radiotherapy
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Procedure: Prostatectomy/Surgery
Radical prostatectomy with or without adjuvant or salvage radiotherapy |
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Active Comparator: Radiotherapy with adjuvant androgen deprivation therapy
Patients with locally advanced prostate adenocarcinoma treated with adjuvant androgen deprivation therapy
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Other: Radiotherapy with adjuvant androgen deprivation therapy
Radiotherapy with adjuvant androgen deprivation therapy |
- Cause specific survival [ Time Frame: Up to 10 years ]Cause-specific survival (CSS) will be calculated as "1-cause specific mortality. Mortality and mortality causes will be ascertained from the nationwide Cause-of-Death Register. In the absence of a functioning Cause-of-Death register, an endpoint committee of at least 2 medical doctors will determine the cause of death.
- Metastasis free survival [ Time Frame: Up to 10 years ]Composite endpoint of time to metastasis and survival
- Quality of life - general psychological, urinary, bowel and sexual health [ Time Frame: At 1,2,5 and 10 years after randomization ]
Questionnaire-based evaluation of general psychological health, urinary health, bowel health, and sexual health.
Questions about self Questions about quality of life in the past month (scale 1 to 7; 1=no quality, 7=the best quality) Depression and anxiety (scale 1 to 7; 1=no, 7=very) Symptom Form (EPIC-26) (scale 1 to 5; 1= no problem, 5=major problem) Questions about the urinary tract Questions about sexual function Questions about bowel function Questions about prostate cancer - diagnosis and treatment Questions about prostate cancer check-ups Questions about hormone/castration therapy and its significance Questions about pain and lymph swelling
- Overall survival [ Time Frame: Up to 10 years ]Overall survival (OS) will be calculated as "1-overall mortality. Mortality data will be ascertained through the nationwide Cause-of-Death Register.
- Time to castration-resistant prostate cancer [ Time Frame: Up to 10 years ]Ascertained at follow-up visits
- Time to biochemical progression [ Time Frame: Up to 10 years ]Ascertained at follow-up visits
- Adverse events [ Time Frame: Up to 10 years ]Ascertained at visits
- Cardiovascular disease [ Time Frame: Up to 10 years ]Data from national PcBaSe-register (https://snd.gu.se/en/catalogue/study/ext0014), a registry where the national prostate cancer registry (NPCR, www.npcr.se) has been linked to the Swedish National Cancer Register, the Cause of Death Register, the Prescribed Drug Register, the National Patient Register, and the Acute Myocardial Infarction Register, the Register of the Total Population, the Longitudinal Integration database for health insurance and labour market studies (LISA), the Multi-Generatioon Register and several other population-based registers.
- Health-care consumption [ Time Frame: Annually up to 10 years ]Annual Defined Daily Dose (DDD) of analgesics, prescription databases
- Health-care consumption [ Time Frame: Annually up to 10 years ]Annual number of days of hospitalization from patient registers
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age ≤75, at the time of randomization
- Diagnosed histopathologically confirmed and untreated prostatic adenocarcinoma
- The general condition and mental status of patients shall permit observation in accordance with the study protocol
- Tumor stage (T, M, N):
T3 stage (as indicated by digital rectal examination or MR imaging or other validated imaging technique) T4 tumors can be included if considered resectable/treatable on MR imaging Significant extra-capsular tumor extension in biopsy (rare but acceptable for inclusion) M0 (no sign of distant metastases) confirmed by bone scan or CT or MRT of axial skeleton (at a maximum of pelvis and lumbar vertebral column) N0 stage, defined in accordance to the RECIST guidelines as no sign of macroscopic retroperitoneal lymph-node metastases >=1.5 cm (short axis) on CT scan, PET-CT, or MRT or more than one suspected lymph-node metastases Presence Gleason grade pattern 4 or 5
- Signed Informed consent
Exclusion Criteria:
- Patients with a PSA value of > 100 ng/mL
- Any medical condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives Patients with contraindications for either prostatectomy or radiotherapy to the prostate are not eligible for the study. Most contraindications for these treatments are relative, but in general, radiotherapy may be precluded among patients with:
- Anorectal disease, such as fistulae, Crohn´s disease, and ulcerative colitis
- Significant obstructive lower urinary tract symptoms
- Proximal stricture of the urethrae
- Severe neurogenic bladder dysfunction
- Enlarged prostate beyond 70-90 ml
- Previous radiotherapy to the pelvic region
On the other hand, surgery may be precluded among patients with:
- Massive local tumor progression, particularly in the apical region
- Massive abdominal obesity
- Contraindications to anesthesia
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02102477
| Contact: Olof Akre, Prof. | +46-8-517 700 00 | olof.akre@ki.se |
Show 30 study locations
| Principal Investigator: | Johan Stranne, M.D ass prof | Sahlgrenska University Hospital, Department of Urology, SE- 413 45 Gothenburg | |
| Principal Investigator: | Camilla Thellenberg Karlsson, MD, PhD | Umeå University Hospital, Department of Radiation Science, SE-901 87 Umeå Sweden | |
| Principal Investigator: | Eva M Johansson, R.N PhD | Karolinska Institute, Nobelsväg, SE- 171 77 Solna, Sweden | |
| Principal Investigator: | Gunnar Steineck, M.D Prof | Karolinska Institute, Nobelsväg, SE-171 77 Solna, Sweden | |
| Principal Investigator: | Klaus Brasso, M.D | Rigshospitalet, department Urology, DK-2001-Copenhagen, Denmark | |
| Principal Investigator: | Peter M Meidahl Petersen, M.D ass prof | Rigshospitalet, Region h, Department of Oncology, Blegdamsvej 9, DK- 2001, Copenhagen, Denmark | |
| Principal Investigator: | Bjørn Brennhovd, M.D ass.prof | Oslo University Hospital, Department of Urology, P.O Box 4950 Nydalen, N-0424, Oslo Norway | |
| Principal Investigator: | Wolfgang Lilleby, M.D ass.prof | Oslo University Hospital, Department of Radiation Therapy, P.O Box 4950, N-0424, Nydalen Oslo, Norway | |
| Principal Investigator: | Antti Rannikko, M.D ass.prof | Helsinki University Central Hospital, Department Urology,Stenbäckinkatu 9, FIN-00290 Helsinki , Finland | |
| Principal Investigator: | Mauri Kouri, M.D PhD | Helsinki University Central Hospital, Department Urology,Stenbäckinkatu 9, FIN-00290 Helsinki , Finland | |
| Principal Investigator: | Tuomas Mirtti, M.D PhD | Helsinki University Central Hospital, Department Urology,Stenbäckinkatu 9, FIN-00290 Helsinki , Finland |
| Responsible Party: | Olof Akre, Professor, Karolinska University Hospital |
| ClinicalTrials.gov Identifier: | NCT02102477 |
| Other Study ID Numbers: |
SPCG-15 |
| First Posted: | April 3, 2014 Key Record Dates |
| Last Update Posted: | May 3, 2021 |
| Last Verified: | April 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
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Prostatic neoplasms Locally advanced Radiotherapy Surgery Mortality |
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms |
Prostatic Diseases Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |