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ADT with or without robot-assisted PSMA-radioguided surgery for patients with recurrent prostate cancer.
Improving the oncological treatment outcomes in men with a biochemical recurrence after primary prostate cancer (PC) treatment that are diagnosed with a disease recurrence confined to the regional lymph nodes or local residual disease using Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography and Computed Tomography (PET/CT.)
The proposed trial randomizes patients with recurrent PC following primary PC treatment to either 6 months of ADT or Technetium-PSMA-radioguided salvage surgery plus 6 months of ADT. Although the optimal duration of ADT is unknown, a minimal duration of 6 months of ADT seems advisable in this setting and will be mandatory for both arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: ADT | Active Comparator | Patients in arm A will receive standard 6 months of ADT according to current clinical guidelines. |
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| Arm B: ADT + PSMA radioguided surgery | Experimental | Patients in arm B will receive standard 6 months of ADT according to current clinical guidelines, and will undergo 99mTechnetium (99mTc)-based PSMA-radioguided salvage surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PSMA-radioguided surgery | Procedure | Approximately 15-24 hours prior to surgery, 400-600 Megabecquerel (MBq) of 99mTc-PSMA-I&S will be intravenously administered to the patient at the Nuclear Medicine department. Following this injection patients will be allowed to return home, and then present for their 99mTechnetium (99mTc)-based PSMA-radioguided salvage surgery the next day. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical progression-free survival (CPFS) | CPFS is defined as time between randomization and the appearance of a recurrence (any N1 or M1) as suggested by PSMA PET/CT or symptoms related to progressive PC, or death due to any cause | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Metastasis-free survival (MFS) | Metastasis-free survival will be defined as the time between randomization and the appearance of a metastatic recurrence (any M1) as suggested by PSMA PET-CT. | 24 months |
| Biochemical progression-free survival (BPFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pim van Leeuwen, MD, PhD | Contact | 003125129111 | pj.v.leeuwen@nki.nl | |
| Lotte Zuur, MD | Contact | 003125129111 | l.zuur@nki.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antoni van Leeuwenhoek Hospital | Recruiting | Amsterdam | North Holland | 1066CX | Netherlands |
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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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| ADT | Drug | Standard 6 months of ADT according to current clinical guidelines. ADT consists of one subcutaneous depot of 22,5mg triptorelin (Pamorelin), with 4 weeks bicalutamide 50mg per os from 2 weeks before till 2 weeks after the first Pamorelin administration. |
|
Biochemical progression-free survival will be defined as the time between randomization and the development of biochemical progression ( three consecutive rises in prostate specific antigen (PSA) 1 week apart, resulting in two 50% increases over the nadir and PSA>2 ng/ml)
| 24 months |
| Castrate resistant prostate cancer (CRPC) | CRPC is defined as castrate serum testosterone<50 ng/dl plus biochemical progression, i.e., three consecutive rises in PSA 1 week apart, resulting in two 50% increases over the nadir and PSA>2 ng/ml. | 10 years |
| Overall survival (OS) | Overall survival will be read as the time from trial randomization to the date of death from any cause | 10 years |
| Incidence of adjuvant therapy | ADT, radiation therapy or additional salvage surgery | 10 years |
| Patient reported QOL as per EORTC-QLQ C30 | Quality of life (QoL) will be assessed with the EORTC Core Quality of Life questionnaire's (QLQ-C30) global QoL scale ranging from 0 to 100, higher scores indicate better QoL | 24 months |
| Patient reported QOL as per Expanded Prostate cancer Index Composite (EPIC) 26 | Quality of life (QoL) will be assessed with the EPIC 26 questionnaire, containing 26 items covering 5 domains: Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better QOL. | 24 months |
| Complications | Assessment of 99mTc-PSMA-I&S injection-related as well as surgery-related complication rate according to Clavien-Dindo. | 30 and 90 days |
| Number of in-field recurrences | Recurrence measured by use of PSMA PET/CT in the template of 99mTc-PSMA-radioguided surgery (RGS) supported salvage surgery | 24 months |
| Specificity of 99mTc-PSMA RGS for salvage surgery for recurrent PC compared to histologic evaluation | In percentage | 30 days |
| Sensitivity of 99mTc-PSMA RGS for salvage surgery for recurrent PC compared to histologic evaluation | In percentage | 30 days |
| Positive Predictive Value of 99mTc-PSMA RGS for salvage surgery for recurrent PC compared to histologic evaluation | In percentage | 30 days |
| Negative Predictive Value of 99mTc-PSMA RGS for salvage surgery for recurrent PC compared to histologic evaluation | In percentage | 30 days |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |