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Less than 50% of patients receiving salvage radiation therapy (SRT) to the pelvis as treatment for prostate cancer relapsing after surgery will achieve undetectable Prostate Specific Antigen (PSA) levels. Despite SRT, two-thirds of patients will again develop elevated PSA, 20% will have distant metastases, and 10% will die from prostate cancer within 10 years. The reason for this is probably preexisting distant metastasis and lymph node metastasises which need to better targeted directly. Additionally , there are well known permanent side effects to SRT.
Standard imaging techniques have poor sensitivity detecting recurrence when PSA is below 1.0 ng/ml. The surface protein Prostate-specific membrane antigen (PSMA) is overexpressed on prostate cancer cells and 68Gallium (68Ga)- and 18Fluorine (18F)-targeted radioligands have been developed. PSMA PET/CT is used increasingly but there is limited data of its impact.
In this study patients with biochemical relapse of prostate cancer after surgery are randomised to the control or experimental group (1:2) and undergo a PSMA PET/CT scan. The experimental group receives individualised therapy based on the result of the PET/CT. The control group receives standard salvage therapy and the result of the PET/CT is blinded. The patients are followed-up with PSA test and quality of life questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm | Experimental | Individualised therapy based on results of the PSMA PET/CT. |
|
| Control arm | Active Comparator | Standard salvage therapy. Results of PSMA PET/CT blinded. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individualised therapy | Combination Product | Group I - No uptake: treated with conventional SRT against the prostate bed. Group II -Uptake only in the prostate bed: will receive intensity modulated RT (IMRT) including Volumetric Modulated Arc Therapy (VMAT) for prostate bed with simultaneous-integrated boost (SIB) to the PET positive uptake in the prostate bed. Group III - Uptake in the prostate bed and involvement of regional lymph nodes in the pelvis: will be treated as Group II plus VMAT for the pelvic lymph nodes with SIB to the PET positive lymph nodes or pelvic lymph nodes salvage lymph node dissection (SLND). Group IV - Uptake in regional lymph nodes only: will be treated with VMAT for the pelvic lymph nodes with SIB to the PET positive lymph nodes or pelvic lymph nodes SLND. Group V - Uptake in extra-pelvic lymph nodes or bone metastasis: systemic treatment instead of surgery or radiation. Local treatment with surgery or radiation is acceptable if curative intention. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary PSA progression free survival | Number of patients with progress defined by Prostate-Specific Antigen (PSA) measurement | Throughout the study, approximately 10 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to metastasis | Time to documented metastasis of prostate cancer | At 5, 7 and 10 years |
| Prostate cancer specific survival | Time to prostate cancer specific death |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefan Carlsson | Contact | 0704871106 | 46 | stefan.carlsson@ki.se |
| Yvonne Larsen | Contact | yvonne.larsen@regionstockholm.se |
| Name | Affiliation | Role |
|---|---|---|
| Stefan Carlsson | Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital | Recruiting | Gothenburg | Göteborg | 413 45 | Sweden |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| Standard salvage therapy | Radiation | Standard salvage radiotherapy |
|
| At 5, 7 and 10 years |
| Time to secondary treatment | Time to need for secondary treatment for prostate cancer | At 5, 7 and 10 years |
| Differences in quality of life recorded using Patient Reported Outcome Measure (PROM) | A modified version of the PSMA questionnaire developed by the National Prostate Cancer Register. Scale from 1 to 5 were 1 is very good and 5 is very bad. | Baseline, 6, 12, 36 and 60 months after completed treatment. |
| Södersjukhuset | Not yet recruiting | Stockholm | Stockholm County | 118 83 | Sweden |
|
| Karolinska University Hospital | Recruiting | Stockholm | Stockholm County | 171 76 | Sweden |
|
| Norrland's University Hospital | Not yet recruiting | Umeå | 901 85 | Sweden |
|
| Örebro University Hospital | Not yet recruiting | Örebro | Örebro County | 701 85 | Sweden |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |