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Rising serum PSA after radiation therapy for localized prostate cancer: Salvage local therapy

Rising serum PSA after radiation therapy for localized prostate cancer: Salvage local therapy
Literature review current through: Jan 2024.
This topic last updated: Jul 05, 2022.

INTRODUCTION — Prostate-specific antigen (PSA) is a sensitive and specific serum marker for prostate tissue. Serial measurements are routinely obtained to detect early disease recurrence in males who have received definitive treatment for localized disease.

The role of definitive salvage therapy after initial radiation therapy (RT; external beam or brachytherapy) is reviewed here. Other aspects of patient management for males with a rising serum PSA following initial RT are discussed separately:

(See "Rising serum PSA following local therapy for prostate cancer: Definition, natural history, and risk stratification".)

(See "Rising serum PSA following local therapy for prostate cancer: Diagnostic evaluation".)

(See "Rising or persistently elevated serum PSA following radical prostatectomy for prostate cancer: Management".)

(See "Role of systemic therapy in patients with a biochemical recurrence after treatment for localized prostate cancer".)

GENERAL APPROACH — Monitoring PSA after treatment of localized prostate cancer can lead to the identification of males with a PSA-only (biochemical) recurrence. In this situation, increases in serum PSA over the baseline after initial treatment are not accompanied by symptoms or signs of locally recurrent or metastatic disease. Many of these males are relatively young and otherwise healthy. For males in whom there is a significant likelihood that disease is confined to the prostate gland, salvage therapy may result in prolonged disease-free survival (algorithm 1).

For patients with a confirmed rise in serum PSA following prior definitive RT, careful evaluation is required to rule out the possibility of distant metastases. The staging evaluation may include computed tomography (CT) of the abdomen and pelvis, bone scan, and/or positron emission tomography (PET) scan using one of the more sensitive prostate cancer-specific radiotracers (eg, F-18 fluciclovine [Axumin]), or prostate-specific membrane antigen (PSMA) PET/CT, where available. (See "Rising serum PSA following local therapy for prostate cancer: Diagnostic evaluation", section on 'Accuracy of individual tests and procedures'.)

In the absence of metastatic disease or other contraindications to local salvage therapy, many clinicians, including the authors and editors associated with this review, perform multiparametric prostate magnetic resonance imaging (MRI) to guide a confirmatory biopsy if salvage surgery/cryotherapy/brachytherapy/or high-intensity focused ultrasound is being considered. The finding of seminal vesicle invasion or extraprostatic extension on multiparametric MRI identifies males who are unlikely to achieve long-term disease control from salvage radical prostatectomy. (See "Rising serum PSA following local therapy for prostate cancer: Diagnostic evaluation", section on 'Males previously treated with radiation therapy'.)

For patients with a positive prostate biopsy, without evidence of disseminated disease, and who are candidates for salvage therapy, treatment options include radical prostatectomy, cryotherapy, and brachytherapy. (See 'Radical prostatectomy' below and 'Cryotherapy' below and 'Brachytherapy' below.)

For patients without disseminated disease who have received definitive RT and are not candidates for salvage therapy, systemic therapy may be indicated. (See "Role of systemic therapy in patients with a biochemical recurrence after treatment for localized prostate cancer".)

DEFINITION OF BIOCHEMICAL FAILURE — The interpretation of changes in serum PSA after RT can be difficult since some normal prostatic glandular tissue is present. Thus, serum PSA levels are unlikely to fall to undetectable levels following a course of RT.

The most widely accepted definition is the so-called Phoenix criteria, established by the American Society for Radiation Oncology (ASTRO) [1]. According to this definition, a PSA rise of ≥2 ng/mL above the nadir PSA is considered a biochemical failure in a patient who was previously treated with definitive RT, with or without androgen deprivation therapy (ADT). Although an increase of 2 ng/mL or more is defined as a biochemical relapse, repeat confirmation is generally carried out to rule out a PSA bounce. (See "Rising serum PSA following local therapy for prostate cancer: Definition, natural history, and risk stratification", section on 'After radiation therapy'.)

PATIENT SELECTION FOR LOCAL SALVAGE THERAPY — Formal criteria have not been established to determine which males are candidates for local salvage therapy following a PSA-only recurrence. The decision of whether or not to proceed to local salvage therapy requires consideration of the likelihood that the disease is locally confined in combination with an assessment of the patient's age and overall health. (See "Rising serum PSA following local therapy for prostate cancer: Diagnostic evaluation".)

Clinical and pathologic parameters at the time of original diagnosis, as well as subsequent events, are helpful in predicting those males who are most likely to benefit from aggressive salvage therapy and least likely to develop distant metastases and die from their disease.

Males who were classified as high or very high risk (table 1) at their original presentation are at increased risk for developing distant disease following initial therapy and are less likely to benefit from local salvage therapy. In particular, this includes males who originally had a histologic grade group of 4 or 5 (Gleason score ≥8), a clinical tumor stage ≥T2c, or a serum PSA level >20 ng/mL [2,3]. This corresponds to prognostic stage groups II and III in the most recent tumor, node, metastasis (TNM) staging system from the American Joint Committee on Cancer (AJCC) (table 2 and table 3).

A shorter interval from treatment to biochemical failure was significantly associated with an increase in prostate cancer-specific mortality in a study of 1722 males treated with RT for prostate cancer [4]. The five-year prostate cancer-specific mortality was significantly higher in those with an interval to biochemical failure <18 months compared with an interval >18 months (26 versus 9 percent).

A short PSA doubling time following initial therapy is correlated with an increased risk of subsequent distant metastases. As an example, in one study, a PSA doubling time <8 months was associated with a 54 percent risk of distant metastases at seven years, and in another report, a PSA doubling time <3 months correlated with a 49 percent risk of distant metastases at three years [5,6].

A serum PSA >10 ng/mL at the time of evaluation for salvage therapy correlates with a poorer outcome following therapy for a PSA-only recurrence [7,8].

Although long-term outcomes are better with early treatment for a PSA-only recurrence, these results may reflect the natural history of the disease and do not necessarily reflect a benefit from therapy. Males with a PSA-only relapse and relatively low PSA levels (particularly those with a low Gleason score, clinical stage T1 or T2 tumors, a long PSA doubling time, and a long interval to PSA recurrence) are more likely to have a prolonged disease course even without treatment. The lack of randomized trials comparing surgery or another form of local therapy versus observation makes it difficult to know whether these males would have remained free of clinical metastases even without salvage therapy. (See "Rising serum PSA following local therapy for prostate cancer: Definition, natural history, and risk stratification", section on 'Risk of metastases or death'.)

Need for biopsy confirmation — Local salvage therapy is associated with the risk of clinically significant toxicity and should not be undertaken unless there is biopsy confirmation of a local recurrence. In the era of improved multiparametric MRI of the prostate, it might be tempting to offer salvage therapy based on MRI alone, but this is not recommended and biopsy confirmation of a local recurrence remains indicated.

OPTIONS FOR SALVAGE THERAPY — There is no consensus on the optimal approach to salvage local therapy and clinical practice is variable. The available options are radical prostatectomy, brachytherapy, and cryotherapy. There are no randomized trials that compare different therapeutic options with each other or with observation in this setting. A systematic review of the literature found the five-year recurrence-free survival rates to be similar with different modalities, although there are differences in the toxicity profiles [9]. The choice of a specific intervention is often dependent on available experience and expertise. Even though high-intensity focused ultrasound (HIFU) is approved by the US Food and Drug Administration (FDA) for destruction of prostate tissue, it is not approved explicitly for the treatment of prostate cancer, and we do not use HIFU to treat locally recurrent prostate cancer. (See "Cryotherapy and other ablative techniques for the initial treatment of prostate cancer", section on 'High-intensity focused ultrasound'.)

Radical prostatectomy — Salvage prostatectomy provides prolonged disease control in many patients. In the pre-PSA era, surgery was not widely used because of concerns about operative morbidity and the frequent development of disseminated metastases. More contemporary experience utilizing better patient selection criteria and improved operative techniques has made radical prostatectomy an important option for appropriately selected patients, particularly those with a life expectancy of 10 to 15 years or more [10]. Although most of the literature is based on open radical prostatectomy, minimally invasive techniques appear to be an option for experienced surgeons [11]. (See "Radical prostatectomy for localized prostate cancer".)

Preoperative evaluation — Prior to surgery, appropriate studies should be conducted to rule out disseminated disease and to provide a tissue confirmation of the diagnosis of a recurrence in the prostate. In males who are candidates for radical prostatectomy, cystoscopic examination is helpful to rule out bladder neck involvement or urethral strictures. (See "Rising serum PSA following local therapy for prostate cancer: Diagnostic evaluation".)

Disease control — The most extensive contemporary evidence on the efficacy of salvage radical prostatectomy comes from a multi-institutional series of 404 males with recurrent prostate cancer following RT [12]. With a median follow-up of 4.4 years, the 10-year biochemical relapse-free, metastasis-free, and cancer-specific survival rates following salvage radical prostatectomy were 48, 83, and 92 percent, respectively. Factors associated with an improved prognosis included a lower serum PSA prior to salvage radical prostatectomy and a lower Gleason score in the post-RT biopsy.

Data on the use of minimally invasive techniques for salvage radical prostatectomy are more limited [13]. Although the results appear similar, more experience and longer follow-up are required [14].

Complications — Radical prostatectomy is technically more challenging and is associated with an increased risk of significant complications in patients who have had prior RT compared with those who have not had prior RT [15]. Older series of patients treated with salvage prostatectomy reported major complications in one-third to one-half of all males [16-18]. These included rectal injury, bladder neck contractures, hemorrhage, ureteral injury, vesicorectal or vesicoperineal fistulas, venous thromboembolism, and chronic urinary incontinence.

These series included many patients who had undergone staging pelvic lymph node dissection and/or open radioactive seed implantation. The degree of fibrosis after modern conformal external beam RT or transperineal brachytherapy is much less, permitting the majority of males to undergo a salvage operation that is similar to the standard non-salvage prostatectomy [19]. In three large contemporary series, the rate of early perioperative complications ranged from 13 to 27 percent [20-22]. A summary of the acute and late complications in three salvage radical prostatectomy series is presented in the table (table 4). (See "Radical prostatectomy for localized prostate cancer", section on 'Functional outcomes'.)

However, late rates of urinary incontinence (30 to 70 percent) and anastomotic stricture (17 to 32 percent) do not appear to have improved substantially despite better patient selection, less pelvic fibrosis, and better surgical technique [15,22,23]. These rates are substantially higher than those observed after radical prostatectomy as initial therapy. This may reflect the persistence of radiation-induced sphincter dysfunction. When the assessment is based on patient-reported data, even higher rates of incontinence have been reported [19]. The incidence of incontinence may also be biased by the use of an artificial urinary sphincter in some patients.

Erectile dysfunction is generally a consequence of salvage prostatectomy. However, nerve preservation is sometimes feasible, and occasional males with adequate preoperative erectile function may recover potency after bilateral nerve-sparing salvage prostatectomy. In one retrospective series, 45 percent of males who were potent preoperatively maintained potency [19], and males were more likely to recover erectile function if they had bilateral preservation of the neurovascular bundles [24].

Perioperative androgen deprivation therapy — There are no randomized trials that address the role of adjuvant or neoadjuvant androgen deprivation therapy (ADT) in males undergoing salvage prostatectomy. Small retrospective series have reported on the use of perioperative ADT in this setting, but these reports do not provide reliable information on the efficacy of these approaches [8,18,25]. Our approach is to perform salvage prostatectomy and monitor PSA postoperatively without adjuvant or neoadjuvant ADT.

Cryotherapy — For males with locally recurrent disease, cryoablation is less invasive than salvage prostatectomy, and it seems to have fewer side effects (particularly incontinence and rectal injury) compared with salvage radical prostatectomy. This approach might be preferred over salvage radical prostatectomy for males over age 70 who have an isolated local recurrence after EBRT, and for any patient who is not willing to accept a 10 to 25 percent risk of long-term incontinence or a 1 to 5 percent risk of rectal injury after salvage radical prostatectomy.

The rationale and techniques for prostate cryotherapy, as well as its use for the initial treatment of prostate cancer, are discussed separately. (See "Cryotherapy and other ablative techniques for the initial treatment of prostate cancer".)

Efficacy — The efficacy of cryoablation as a salvage therapy following RT has been evaluated only in retrospective series. Many of these reports used older cryotherapy techniques, and their interpretation is further limited by variable definitions of biochemical failure.

The most extensive data come from an analysis of 328 patients who underwent salvage cryosurgery between 1994 and 2011 [26]. Primary treatment had included external beam RT or brachytherapy in 308 cases (94 percent) and cryotherapy in 20 patients (6 percent). The 5- and 10-year recurrence-free survival rates were 63 and 35 percent, respectively, and the 5- and 10-year disease-specific survival rates were 91 and 79 percent, respectively. Factors associated with a better prognosis included an increasing time interval from original treatment to salvage therapy, a lower serum PSA level at the time of surgery, and a lower PSA nadir after cryotherapy.

Similar results have been reported in other series [27-29].

Complications — Patients can experience the same range of complications following salvage cryotherapy as have been observed when cryotherapy is used for the treatment of primary localized prostate cancer. (See "Cryotherapy and other ablative techniques for the initial treatment of prostate cancer", section on 'Complications'.)

However, the complications of salvage cryotherapy appear to be more common and more severe than those of primary cryotherapy. These differences include the full array of potential cryotherapy complications. As with cryoablation for primary therapy of prostate cancer, effective urethral warming is essential to reduce complications and maximize quality of life for males undergoing salvage cryoablation [30].

In the Cryo On-Line Data (COLD) registry series, urinary incontinence sufficient to require the use of pads was reported in 4 percent of cases [27]. However, the reported rates of incontinence were substantially higher in a study that relied on patient, rather than clinician, reporting [31]. Forty-six males undergoing salvage cryotherapy were asked to complete quality of life forms before and after therapy. Urinary bother was a moderate to big problem 24 months after cryotherapy in 29 percent; 73 percent reported leaking of urine daily or weekly, and 53 percent needed one or more pads daily.

The net effect is that salvage cryotherapy may not offer quality of life advantages compared with salvage prostatectomy in males with locally recurrent disease following RT [30]. However, the modern argon-based cryotherapy technique seems to have fewer complications than older techniques [27]. (See "Cryotherapy and other ablative techniques for the initial treatment of prostate cancer", section on 'Technique'.)

Cryotherapy versus salvage prostatectomy — There are no prospective studies that directly compare cryosurgery with radical prostatectomy or brachytherapy after failure of external beam RT.

A retrospective study compared 42 males treated with salvage prostatectomy at the Mayo Clinic with 56 patients treated with salvage cryotherapy at MD Anderson Cancer Center. Patients were matched for pretreatment PSA and biopsy Gleason score [32]. Biochemical progression occurred more frequently in patients treated with salvage cryotherapy than in those treated with radical prostatectomy (five-year biochemical relapse-free survival 66 versus 42 percent, based on a criterion of two increases in serum PSA above the nadir). There was no difference in five-year disease-specific survival (96 versus 98 percent). The choice of therapy needs to be individualized, and cryotherapy is appropriate for older patients and those with significant comorbidity.

Cryotherapy can freeze and destroy tissue beyond the confines of the prostate gland, and this may be an advantage compared with radical prostatectomy in some patients. Guidelines from the American Urological Association (AUA) support cryotherapy as an option in this setting [33].

Brachytherapy — Brachytherapy is another option for salvage treatment in males with a biochemical recurrence following initial management with external beam RT [34]. Brachytherapy is typically given using a low-dose-rate methodology with iodine-125 (I-125) or palladium-103 (Pd-103) [35-40], but it can also be given using a high-dose-rate technique [41-43]. (See "Brachytherapy for low-risk or favorable intermediate-risk, clinically localized prostate cancer", section on 'Technique'.)

There are no randomized trials comparing brachytherapy with other forms of salvage therapy. The following results are available from uncontrolled trials and retrospective analyses:

In the prospective multicenter phase II RTOG 0526 trial, in which 100 individuals with low/intermediate-risk prostate cancer before EBRT who had a biopsy-proven local recurrence >30 months after RT, a PSA <10 ng/mL, and no evidence of regional/distant disease (as assessed by bone scan and abdominopelvic CT scan) all received transperineal template-guided LDR brachytherapy using either iodine-125 or palladium-123 seeds [40]. Overall, 92 were eligible and received protocol treatment. Concurrent or prior ADT was prescribed for 16 percent at the time of salvage; with minimum five-year follow-up (median 6.7 years), the five-year freedom from biochemical failure rate was 68 percent. At ten years, local failures were rare (5 percent), but 46 percent had biochemical failure. Ten-year overall survival was 70 percent; of the 19 patients who died, five died from their prostate cancer, 10 from other causes, 4 of unknown causes. Treatment-related toxicity was not reported.

Additional information, including toxicity information is available from one of the largest retrospective series, which included 108 males with a biopsy-proven local recurrence after external beam RT underwent salvage low-dose-rate brachytherapy [39]. At an average follow-up of 6.3 years, the freedom from biochemical failure rates at 5 and 10 years were 63 and 52 percent, respectively, and rates of prostate cancer-specific survival were 91 and 78 percent, respectively. Grade 3 toxicity occurred in 17 percent of patients, mostly genitourinary (15.7 percent) rather than gastrointestinal (2.8 percent), and the vast majority were late, occurring more than six months following brachytherapy.

High-intensity focused ultrasound — HIFU uses sonic waves to create thermal energy that destroys the target tissue within the prostate. HIFU has been used as salvage therapy for the treatment of biopsy-proven recurrent prostate cancer following RT [44]. Updated guidelines on treatment of prostate cancer from the European Society of Medical Oncology also include HIFU as an option for local salvage therapy after initial RT for localized prostate cancer [45]. However, the risk of significant complications in this setting is higher compared with primary therapy [46]. Given that HIFU lacks robust evidence of efficacy both for primary and savage treatment, and that even though HIFU is approved by the FDA for destruction of prostate tissue, it is not approved explicitly for the treatment of prostate cancer, and we do not use HIFU to treat locally recurrent prostate cancer. (See "Cryotherapy and other ablative techniques for the initial treatment of prostate cancer", section on 'High-intensity focused ultrasound'.)

SUBSEQUENT BIOCHEMICAL RECURRENCE — Serum PSA levels should be monitored after salvage therapy (eg, radical prostatectomy) for a biochemical recurrence following RT. Evidence of a further biochemical recurrence is not uncommon in this situation.

The primary approach to management of a subsequent biochemical recurrence is androgen deprivation therapy (ADT). The optimal timing for the initiation of ADT in this situation is not clear. (See "Role of systemic therapy in patients with a biochemical recurrence after treatment for localized prostate cancer", section on 'ADT monotherapy'.)

SOCIETY GUIDELINE LINKS — Links to society and government-sponsored guidelines from selected countries and regions around the world are provided separately. (See "Society guideline links: Diagnosis and management of prostate cancer".)

SUMMARY AND RECOMMENDATIONS

Definition of biochemical failure – The routine monitoring of serum prostate-specific antigen (PSA) after treatment of early stage prostate cancer has led to the identification of males with a PSA-only (biochemical) recurrence without symptoms or signs of locally recurrent or disseminated prostate cancer. The most widely accepted definition of biochemical failure following radiation therapy (RT) is the Phoenix criteria. According to this definition, a PSA rise of ≥2 ng/mL above the nadir PSA following definitive RT (external beam or brachytherapy) is considered a biochemical failure. (See 'Definition of biochemical failure' above.)

Patient selection for salvage therapy – Formal criteria have not been established to determine which males are candidates for local salvage therapy following a PSA-only recurrence. The decision of whether or not to proceed to local salvage therapy requires consideration of the likelihood that the disease is locally confined in combination with an assessment of the patient's age and overall health. Tissue confirmation of the localized recurrence should be pursued prior to salvage local therapy. (See "Rising serum PSA following local therapy for prostate cancer: Diagnostic evaluation" and 'Patient selection for local salvage therapy' above.)

Options for salvage local therapy

There is no consensus on the optimal approach to salvage local therapy and clinical practice is variable. The available options are radical prostatectomy, brachytherapy, and cryotherapy. There are no randomized trials that compare different therapeutic options with each other or with observation in this setting. Five-year recurrence-free survival rates appear to be similar with different modalities, although there are differences in the toxicity profiles. Key factors in choosing the approach include age, comorbidity, patient preferences, and the availability of local experience and expertise. (See 'Options for Salvage therapy' above.)

Even though high-intensity focused ultrasound (HIFU) is approved by the US Food and Drug Administration for destruction of prostate tissue, it is not approved explicitly for the treatment of prostate cancer, and we do not use HIFU to treat locally recurrent prostate cancer. (See 'High-intensity focused ultrasound' above.)

ACKNOWLEDGMENT — We are saddened by the death of Nicholas Vogelzang, MD, who passed away in September 2022. UpToDate gratefully acknowledges Dr. Vogelzang's role as Section Editor on this topic, and his dedicated and longstanding involvement with the UpToDate program.

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References

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